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Chaitanya, B., Pai, K.M., Yathiraj, P.H., Fernandes, D., & Chhaparwal, Y. (2017). Rebamipide gargle in preventive management of chemo-radiotherapy induced oral mucositis. Oral Oncology, 72, 179–182.

Study Purpose

The aim of the study to evaluate the efficacy of a Rebamipide gargle in the prevention and treatment of chemoradiotherapy-induced oral mucositis.

Intervention Characteristics/Basic Study Process

All participants received bottles of gargle and were advised to gargle with 20 ml of gargle, six times a day (breakfast, 11 am lunch, 3 pm dinner, and at bedtime) beginning on the first day of radiotherapy and ending at the completion of radiotherapy. The gargle provided to both groups were identical in ingredients except for the one given to the intervention group, which contained an extra ingredient (Rebamipide). Daily oral exams were conducted at the beginning of radiotherapy and concluded at the end of radiotherapy to determine the onset of oral mucositis.

Sample Characteristics

  • N = 60 (n = 30 in intervention and control groups)    
  • AGE: 34-75 years
  • MALES: 98%    
  • FEMALES: 1%
  • KEY DISEASE CHARACTERISTICS: Participants were aged 18 years of age or older who were undergoing radiation therapy for newly diagnosed head and neck squamous cell carcinoma.
  • OTHER KEY SAMPLE CHARACTERISTICS: 13% had stage I/II cancer and 86% had stage III/IV cancer.

Setting

  • SITE: Not stated/unknown    
  • SETTING TYPE: Not specified  
  • LOCATION: Unknown

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active anti-tumor treatment
  • APPLICATIONS: Elder care, palliative care

Study Design

Randomized, double-blinded placebo controlled study.

Measurement Instruments/Methods

Numeric scale and the RTOG grading system. Statistical methods used were the IBM SPSS Statistics, version 18, with comparison of variables done using an Independent sample t test and Mann-Whitney U test. Chi-square test was used to compare categorical variables.

Results

A statistically significant delay of onset of mucositis of 3.5 days was found in the intervention group as compared to the control group. A statistically significant reduction in numeric and RTOG pain scores were also found in the intervention group as compared to the control group.

Conclusions

Rebamipide gargle is effective in delaying the onset of oral mucositis and in reducing the severity of pain of oral mucositis in patient undergoing chemotherapy and radiation therapy for head and neck cancer.

Limitations

Small sample (< 100)

 

Nursing Implications

CAM 2028 can be effective in treating pain induced oral mucositis from radiation therapy. Benzydamine does not contribute to the reduction of oral mucositis pain.

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Eslami, H., Pouralibaba, F., Falsafi, P., Bohluli, S., Najati, B., Negahdari, R., & Ghanizadeh, M. (2016). Efficacy of Hypozalix spray and propolis mouthwash for prevention of chemotherapy-induced oral mucositis in leukemic patients: A double-blind randomized clinical trial. Journal of Dental Research, Dental Clinics, Dental Prospects, 10, 226–233.

Study Purpose

To evaluate Hypozalix artificial saliva and propolis mouthwash efficacy for the prevention of chemotherapy-induced oral mucositis in patients with leukemia.

Intervention Characteristics/Basic Study Process

Double-blind RCT with patients assigned to three groups. The control group used the CHX mouthwash and fluconazole. Group 1 and 2, Hypozalix and propolis mouthwashes, respectively, added to combination therapy used in control group. Results compared between three groups after 14 days.

Sample Characteristics

  • N: 72   
  • AGE: 1-71 years
  • MALES: Matched  
  • FEMALES: Matched
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Leukemia and chemotherapy
  • OTHER KEY SAMPLE CHARACTERISTICS: Starting similar chemotherapy regimens, matched

Setting

  • SITE: Single site   
  • SETTING TYPE: Inpatient    
  • LOCATION: Oncology Dept of Shahid Ghazi Hospital in Tabriz

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active anti-tumor treatment
  • APPLICATIONS: Pediatrics, elder care

Study Design

Double-blind RCT, one control and two intervention groups.

Measurement Instruments/Methods

Descriptive two-part questionnaire checklist and OM severity checklist. The tool used to collect data was a two-part questionnaire and a checklist to determine the severity of mucositis. The two-part questionnaire was used to collect demographic data (age and gender) and consisted of questions on the type of disease, history of chemotherapy, presence or absence of systemic disease other than malignancy, and the presence or absence of skin or respiratory allergy. The second part of the questionnaire consisted of questions on the severity of xerostomia, ease of mastication and swallowing, the severity of burning sensation, the quality of sleep during the night, and the tendency to continue to use the medications; the patients completed this part before and after the intervention. In addition, in order to determine the severity of oral mucositis, a checklist was used, which was designed based on the criteria of WHO; based on these criteria, oral mucositis is divided into five distinct grades from 0 to 4.17. To determine validity of the questionnaire, content validity method was used. To determine reliability of the questionnaire, simultaneous observation technique was used. To this end, observations were carried out by two observers with similar characteristics, using similar guidelines on 10 samples, which yielded a correlation coefficient of 0.94. Then, the questionnaire was completed using interviews and patient files.

Results

After 14 days, 50% of patients in the control group (CHX mouthwash and fluconazole) exhibited signs of recovery from xerostomia. For group 2 (propolis mouthwash and CHX mouthwash and fluconazole), 50% of patients exhibited some signs of recovery from xerostomia. 95.8% patients in group 1 (CHX mouthwash and fluconazole and Hypozalix spray) reported recovery from xerostomia. Chi-squared test statistically significant (p = 0.0006). At the end of the study, 29.17% in control group, 87.5% in group 1, and 70.83% in group 2 exhibited easy mastication. Chi-squared test significant statistically (p = 0.0001). 33.3% in control group, 63.3% in group 1, and 87.5% of patients in group 2 exhibited easy swallowing. Chi-squared test statistically significant (p < 0.0001). At end of study, 33.3% in control group, 58.3% in group 1, and 91.6% in group 2 were interested in continuing to use the product. Chi-squared test statistically significant (p = 0.0002). 16.67% of patients in control group, 25% in group 1, and 62.5% in group 2 exhibited more full night’s sleep and less waking up. Chi-squared test statistically significant (p = 0.0018). In relation to an improvement in oral burning sensation, 8.33% of patients in control group, 25% in group 1, and 91.67% in group 2 exhibited decrease in burning sensation. Chi-squared test significant statistically (p < 0.0001). 62.5% of patients in control group, 62.5% in group 1, and 95.8% in group 2 had a higher rate of feeling comfortable. Chi-squared test was significant (p = 0.0103). A clinical examination of patients five days after using the medications showed 8.33% of patients in control group, 12.5% in group 1, and 50% in group 2 were free of mucositis. However, 25% of patients in control group and 16.6% in group 1 had grade 4 mucositis. None in group 2 exhibited grade 4 mucositis. Chi-squared test significant (p = 0.0007). A clinical examination of patients 10 days after using the medications showed 25% of patients in control group, 33.3% in group 1, and 50% in group 2 were free of mucositis. 12.5% of patients in control group and 4.17% in group 1 had grade 4 mucositis. None in group 2 had grade 4 mucositis. However, chi-squared test indicated that the difference was not statistically significant (p = 0.1135).

Conclusions

50% of patients in control group, 95.8% of patients who received Hypozalix, and 50% who received Propolis exhibited decrease in xerostomia severity. 29.17% of patients in control group, 87.5% in Hypozalix group, and 70.83% in Propolis group exhibited easy mastication. 33.3% of patients in control group, 63.3% of patients in Hypozalix group, and 87.5% of patients in Propolis group exhibited easy swallowing. 91.6% of patients in propolis group were interested in continuing to use product. The lowest tendency was seen in control group patients, followed by those in Hypozalix group. 62.5% of patients in propolis group exhibited less waking up at night and 95.8% of them had a higher rate of feeling comfortable. The lowest burning sensation was detected in that group. Propolis resulted in significantly greater decrease in severity of mucositis compared to Hypozalix and control group five days after using medications. These contradictory results might be attributed to differences in study designs and in Propolis origins. In many cases, use of Propolis mouthwash yielded significantly better results, and patients exhibited a greater tendency to continue to use it. If results of this study are confirmed by other studies, treatment with Propolis can reduce secondary oral infections and mucositis caused by chemotherapy. Since Propolis and Hypozalix had positive effects on decreasing mucositis induced by chemotherapy in this study, toothpastes may be designed with propolis base. Hypozalix spray or propolis mouthwash in association with CHX mouthwash and fluconazole simultaneously at the start of chemotherapy resulted in decrease in chemotherapy complications after 14 days. Propolis mouthwash yielded better results and the patients exhibited greater tendency to continue to use it.

Limitations

  • Small sample (< 100)
  • Other limitations/explanation: Small study with limitations in descriptive measurement.
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Huang, B.S., Wu, S.C., Lin, C.Y., Fan, K.H., Chang, J.T., & Chen, S.C. (2018). The effectiveness of a saline mouth rinse regimen and education programme on radiation-induced oral mucositis and quality of life in oral cavity cancer patients: A randomised controlled trial. European Journal of Cancer Care, 27, e12819.

Study Purpose

To assess the impact of saline mouth rinse regimen and education program on radiation-induced OM symptoms and QOL in patients with oral cavity cancer receiving RT or CCRT.

Intervention Characteristics/Basic Study Process

Ninety‐one OCC patients were randomly divided into a group that received saline mouth rinses and an education program and a control group that received standard care. OM symptoms and QOL were assessed with the WHO Oral Toxicity Scale, MSS‐moo, and UW‐QOL. Data were collected at the first postoperative visit to the radiation department (T0) and at 4 weeks and 8 weeks after beginning RT or CCRT.

Sample Characteristics

  • N: 91   
  • AGE: 20 years or older
  • MALES: 93.8%  
  • FEMALES: 6.2%
  • CURRENT TREATMENT: Radiation, combination radiation and chemotherapy  
  • KEY DISEASE CHARACTERISTICS: Diagnosed with oral cavity cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Undergoing postoperative adjuvant RT or CCRT

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Cancer center in northern Taiwan

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active anti-tumor treatment
  • APPLICATIONS: Elder care

Study Design

Double-blind RCT one control and two intervention groups.

Measurement Instruments/Methods

OM symptoms and QOL were assessed with the WHO Oral Toxicity Scale, MSS‐moo, and UW‐QOL. Data were collected at the first postoperative visit to the radiation department (T0) and at 4 weeks and 8 weeks after beginning RT or CCRT.

Results

Patients in both groups had significantly higher levels of physical and social‐emotional QOL at 8 weeks after beginning RT or CCRT compared to the first visit. Patients in the saline rinse group had significantly better physical and social‐emotional QOL as compared to the standard care group at 8 weeks. Radiation‐induced OM symptoms and overall QOL were not different between the groups.

Conclusions

The authors concluded that the saline rinse and education program promote better physical and social‐emotional QOL in OCC patients receiving RT/CCRT. The results of this study indicated that saline mouth rinses with an education program were effective in increasing physical and social‐emotional QOL by improving the radiation‐induced OM symptoms and promoting oral comfort in patients receiving RT/CCRT for HNC, as compared to standard care. However, no improvement in radiation‐induced OM symptoms and overall QOL was found.

Limitations

  • Small sample (< 100)
  • Other limitations/explanation: Small study with limitations in descriptive measurement.

Nursing Implications

It might be helpful to provide and teach saline mouth rinses to patients

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Hashemipour, M.A., Barzegari, S., Kakoie, S., & Aghahi, R.H. (2017). Effects of omega-3 fatty acids against chemotherapy-induced mucositis: A double-blind randomized clinical trial. Wounds, 29, 360–366. 

Study Purpose

To evaluate the efficacy and route of administration of omega-3 fatty acids for the prevention and treatment of oral mucositis.

Intervention Characteristics/Basic Study Process

Patients were randomized to omega-3 (two capsules daily with meals, each capsule contained 2,000 mg of fish oil plus EPA/DHA). The placebo contained corn oil with EPA/DHA.

Sample Characteristics

  • N = 30 control group, 30 in the omega 3-fatty acid intervention group  
  • AGE: 22-63 years old
  • MALES: 23 (38%)  
  • FEMALES: 37 (62%)
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Leukemia or breast cancer diagnosis 
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients were actively undergoing chemotherapy treatments with WHO grade I mucositis and were not to be treated with chemical agents.

Setting

  • SITE: Single site   
  • SETTING TYPE: Not specified    
  • LOCATION: Kerman, Iran

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active anti-tumor treatment
  • APPLICATIONS: Elder care, palliative care

Study Design

Double-blinded random control study

Measurement Instruments/Methods

Mucositis was evaluated based on the WHO, Oral Mucositis Weekly Questionnaire (OMPQ), and Western Consortium for Cancer Nursing Research (WCCNR) criteria.

Results

At 1 and 2 weeks, the severity of mucositis was lower in the omega-3 group compared with the control group and, after 2 weeks, there was no evidence of mucositis in the patients taking omega-3. Patients taking omega-3 compared with the placebo exhibited a better ability to eat, and the difference between the two groups was statistically significant (p = 0.002). The average duration of mucositis in the omega-3 group was 5.5 days and in the placebo groups, 10-12 in the placebo group. The mean pain intensity scores during the first 24 hours were 5 ± 5.4 and 8 ± 6.4 in the omega-3 and placebo groups, respectively. The maximum and minimum values of pain severity scores in the omega-3 group were 6 and 0 in the placebo group. The patients’ quality of life in both groups showed a statistically significant difference in weeks 2 and 3 (p = 0.01).

Conclusions

Omega-3 fatty acids show promise in reducing the severity and duration of mucositis as well as the associated pain intensity.

Limitations

  • Small sample (< 100)
  • Other limitations/explanation: Only two types of diagnosis breast cancer and leukemia were included.

Nursing Implications

These results show promise for treating patients with oral mucositis with omega-3 fatty acid.

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Antunes, H.S., Herchenhorn, D., Small, I.A., Araujo, C. M., Viegas, C.M.P., de Assis Ramos, G., . . . Ferreira, C.G. (2017). Long-term survival of a randomized phase III trial of head and neck cancer patients receiving concurrent chemoradiation therapy with or without low-level laser therapy (LLLT) to prevent oral mucositis. Oral Oncology, 71, 11–15.

Study Purpose

To compare between LLLT and placebo for overall disease-free survival (DFS) and progression-free survival (PFS) of patients with head and neck cancer who received chemoradiation therapy. Randomized double-blinded placebo controlled phase III trial

Intervention Characteristics/Basic Study Process

Patients received low-level laser therapy or placebo; LLLT with an InGaAIP diod (660 nm to 100 mW-1 J-4J/cmsq, and a spot size of 0.24 cm2 five days a week before radiotherapy. contact with the mucosa on nine points per region for 10 seconds per point, totaling 12 minutes per patient for LLLT.

Sample Characteristics

  • N: 94; laser group = 47, placebo group = 47    
  • AGE: Mean age of LG = 53.5, PG = 55.7; non-significant
  • MALES: LG male, 89.4%; PG male, 85.1%    
  • FEMALES: LG female, 10.6 %; PG female, 14.9%
  • CURRENT TREATMENT: Combination radiation and chemotherapy
  • KEY DISEASE CHARACTERISTICS: Head and neck cancer (nasopharynx, oropharynx, and hypopharynx cancer)

Setting

  • SITE: Not stated/unknown Instituto Nacional de Câncer (INCA)
  • SETTING TYPE: Not specified    
  • LOCATION: Rio de Janeiro Brazil

Phase of Care and Clinical Applications

PHASE OF CARE: Active anti-tumor treatment

Study Design

Randomized phase III trial of patients with head and neck cancer. Details of randomization not provided.  

Both group received treatments of chemotherapy (cisplatin 100 mg/m2 at day 1, 22, and 43) and radiotherapy according to tumor localization, using megavoltage radiotherapy with 2D and 3D techniques. A total dose of 70.2 Gy daily in 39 fractions, five days a week, using a cobalt-60 and a linear accelerator unit.

Measurement Instruments/Methods

The adverse effects were evaluated daily, according to the Common Toxicity Criteria, version 3.0, from the National Cancer Institute (NCI-CTC) [16]. Oral mucositis was evaluated every day during the treatment period, according to the OMS and OMAS scales. The modified visual analog scale was used to evaluate pain. Body weight (body mass index) was measured every week. Patients were evaluated by a complete physical examination, oroscopy, nasopharyngoscopy, hematologic and biochemical profiles, chest radiography, and CT/MRI performed every four months for the first two years, every six months from the third to the fifth year, and then annually according to the RECIST criteria.

Results

  • Overall survival: LG 57.4% versus PG 40.4%; p = 0.9 NS; HR = 1.64; 95% CI [0.92, 2.91]
  • DFS: PG 65.9% versus 58.6%; p = 0.659 NS; HR = 1.19; 95% CI [0.55, 2.57]
  • PFS*: 61.7% versus 40.4%; p = 0.03; HR = 1.93; 95% CI [1.07, 3.5] 
  • OM stage 3-4*: LG 6.3% versus PG 48% (p < 0.001)
  • Gastrostomies*: LG 14.9% versus PG 38.3%; RRR = 0.39 (95% CI [0.18, 0.84]), p = 0.01
  • Complete chemotherapy interruption: LG 12.8% versus PG 19.1%
  • Chemotherapy dose reduction: LG 2.1% versus PG 6.4%
  • Opioid use*: LG = 31.9% versus PG = 85.1; RRR = 0.38 (95% CI [0.24, 0.58]; p < 0.001
  • Temporary radiotherapy interruption due to radiodermatitis: LG 14.9% versus PG 8.5%

* statistically significant findings.

Conclusions

Laser group had better progression-free survival and complete response, however this did not carry over to overall survival significance. Oral mucositis severity was statistically significantly lower in LLLT group.

Limitations

  • Small sample (< 100)
  • Unintended interventions or applicable interventions not described that would influence results
  • Subject withdrawals ≥ 10%
  • Other limitations/explanation: Limited information in article regarding original study, so do not have many details that would be helpful

Nursing Implications

LLLT was beneficial to reduce oral mucositis. No statistically significant results for overall survival is likely affected by type II error (small sample size), and larger sample size study is needed. This study found statistically significant improvement for progression-free survival and LLLT may improve not only mucositis occurrence/severity but also patients’ survival.

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Zheng, B., Zhu, X., Liu, M., Yang, Z., Yang, L., Lang, J., . . . Zhu, G. (2018). Randomized, double-blind, placebo-controlled trial of Shuanghuabaihe tablets to prevent oral mucositis in patients with nasopharyngeal cancer undergoing chemoradiation therapy. International Journal of Radiation Oncology, Biology, Physics, 100, 418–426.

Study Purpose

To evaluate if Shaunghaubaihe tablets can prevent oral mucositis for patients with locally advanced nasopharyngeal carcinoma undergoing chemoradiotherapy.

Intervention Characteristics/Basic Study Process

Multi-site, randomized, double blind study of Shuanghuabaihe tablets versus placebo (four tablets, three times a day) started at the initiation of chemoradiotherapy and lasting seven weeks. Patients could stop taking the tablets if grade 3 mucositis developed.

Sample Characteristics

  • N = 240   
  • AGE: 18-70 years old 
  • MALES: 70% (intervention) and 63.03% (placebo)  
  • FEMALES: 30% (intervention) and 36.97% (placebo)
  • CURRENT TREATMENT: Combination radiation and chemotherapy
  • KEY DISEASE CHARACTERISTICS: Nasopharyngeal carcinoma

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Not specified    
  • LOCATION: China

Phase of Care and Clinical Applications

PHASE OF CARE: Active anti-tumor treatment

Study Design

RCT. Patients age 18-70 years with locally advanced nasopharygeal carcinoma randomly assigned to receive Shaunghaubaihe tablets or a placebo, starting at the initiation of chemoradiation.

Measurement Instruments/Methods

The incidence of different stages of mucositis was compared using Fisher’s exact test and the 95% confidence intervals. The Kaplan-Meier method was used to estimate the median time of the occurrence of OM (latency). To compare latency, the Cox proportional hazard model was used for hazard ratio (HR) and 95% CI values. One-way ANOVA and Fisher’s exact were used to compare toxicities and secondary efficacy endpoints. All data was analyzed using SAS, version 9.2, software.

Results

Shaunghaubaihe tablets significantly reduced the incidence, latency, and severity of oral mucositis in patients with nasopharyngeal cancer.

Limitations

Two patients from placebo and eight from treatment arm did not complete the entire course of radiation therapy. This is an initial study and further clinical study is needed to evaluate and verify therapeutic effects.

Nursing Implications

Therapeutic agents that prevent oral mucositis are needed because systemic oral care alone is insufficient.

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Wang, C., Wang, P., Ouyang, H., Wang, J., Sun, L., Li, Y., . . . Pan, Z. (2017). Efficacy of traditional Chinese medicine in treatment and prophylaxis of radiation-induced oral mucositis in patients receiving radiotherapy: A randomized controlled trial. Integrative Cancer Therapies, 17, 444–450.

Study Purpose

To estimate the efficacy of traditional Chinese medicine (Chining decoction, CHIN) for radiation-induced oral mucositis in patients with head and neck cancer.

Intervention Characteristics/Basic Study Process

70 consecutive patients were randomly assigned to receive CHIN (treatment group) or recombinant human epidermal growth factor (rhEGF) spray (control group) at a 1:1 ratio in the period between May 2014 to December 2015. CHIN was administered to treatment group from the first day of radiotherapy until the completion of radiotherapy. Simultaneously, the rhEGF spray was administered to control group on the oral mucosa of the irradiated area. The clinical benefit was determined by gradation of mucositis (Common Terminology Criteria for Adverse Events, version 4.0), oral pain, and xerostomia (visual analysis scale) for each week during radiotherapy. Body mass index was evaluated before and after radiotherapy.

Sample Characteristics

  • N = 70   
  • AGE: 17-76
  • MALES: 76%  
  • FEMALES: 24%
  • CURRENT TREATMENT: Radiation
  • KEY DISEASE CHARACTERISTICS: Head and neck cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: No history of oral ulcer and salivary gland diseases, No history of anti-tumor therapies.

Setting

  • SITE: Single site   
  • SETTING TYPE: Inpatient    
  • LOCATION: China

Phase of Care and Clinical Applications

PHASE OF CARE: Active anti-tumor treatment

Study Design

Prospective control randomized trial

Measurement Instruments/Methods

  • The National Cancer Institute Common Toxicity Criteria Oral Mucositis Scale.
  • Oral pain and xerostomia were assessed by the patients with the visual analysis scale (VAS).
  • Body mass index (BMI) was used to assess the nutritional status of patients before and after treatment.

Results

  • Patients in the treatment group had prominent remission of oral pain and grade of mucositis on each observing point compared with those in control group (p < 0.01).
  • Xerostomia was decreased notably in treatment group compared with control group (p < 0.01).
  • The degrees of OM in the treatment group were 1.57 (SD = 0.51) versus 2.49 (SD = 0.7) in the control group (p < 0.01).

Conclusions

CHIN presented an obvious advantage in preventing radiation-induced oral mucositis compared with rhEGF spray.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)

 

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Marucci, L., Farneti, A., Di Ridolfi, P., Pinnaro, P., Pellini, R., Giannarelli, D., . . . Sanguineti, G. (2017). Double-blind randomized phase III study comparing a mixture of natural agents versus placebo in the prevention of acute mucositis during chemoradiotherapy for head and neck cancer. Head and Neck, 39, 1761–1769.

Study Purpose

To test the effectiveness of four natural compounds (propolis, aloe vera, calendula, and chamomile) in the prevention of acute mucositis during chemoradiotherapy for head and neck cancer.

Intervention Characteristics/Basic Study Process

The patients were randomized to receive a mixture of the natural ingredients or placebo. All patients received dental and nutritional evaluations and were allowed to use standard supportive care such as baking soda mouth rinses, NSAIDs, opioids, and IV hydration. The placebo had the same volume, color, flavor, and density as the experimental solution. The pharmacist who dispensed the study drugs managed the randomization list. Patients were instructed to rinse with 7 ml four times per day (before each meal and RT) during weekdays and before each meal (three times per day) on weekends. Weekly interviews were conducted along with a physical examination, including visual inspection of the oral cavity and the oropharynx, by a nurse and a radiation oncologist. Body weight, objective mucositis, pain control, and dysphagia were assessed during these visits.

Sample Characteristics

  • N = 104   
  • AGE: median = 57 years
  • MALES (%): 86.45  
  • FEMALES (%): 13.55
  • CURRENT TREATMENT: Combination radiation and chemotherapy
  • KEY DISEASE CHARACTERISTICS: Head and neck
  • OTHER KEY SAMPLE CHARACTERISTICS: Squamous cell carcinoma of the oral cavity, pharynx, or larynx. Squamous cell carcinoma in the neck of unknown primary. Previously untreated with chemotherapy or radiation therapy for head and neck cancer, good oral intake with no feeding tubes (NG or PEG) at study entry, and ECOG 0-1.

Setting

  • SITE: Single site   
  • SETTING TYPE: Not specified    
  • LOCATION: Regina Elena National Cancer Institute, Rome, Italy

Phase of Care and Clinical Applications

PHASE OF CARE: Active anti-tumor treatment

Study Design

Phase III double-blind randomized placebo controlled; 1:1 experimental versus control

Measurement Instruments/Methods

CTCAE, version 3.0, was used for grading mucositis. The Verbal Descriptor Scale was used for assessing pain. Locoregional control and OS were computed with the Kaplan-Meier method from the last day of treatment and comparison was done with the log-rank test (These were included in the secondary endpoints of the study).

Results

No difference was noted between arms.

Conclusions

The prophylactic use of the natural agent combination, propolis, aloe vera, calendula, and chamomile, did not show a benefit versus placebo in the prevention of oral mucositis for patients with head and neck cancer receiving chemoradiotherapy.

Limitations

This was a well-conducted single-site clinical trial.

Nursing Implications

Use of natural ingredients for supportive care in oncology is usually preferable to more expensive, hard to access pharmacologic interventions. However, if the evidence does not support their use, even natural ingredients should not be used due to potential increase costs and untoward effects. Nurses play an important role in patient and HCP education about evidence-based interventions.

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Mazzola, R., Ricchetti, F., Fiorentino, A., Giaj-Levra, N., Fersino, S., Tebano, U., . . . Alongi, F. (2016). Fentanyl pectin nasal spray for painful mucositis in head and neck cancers during intensity-modulated radiation therapy with or without chemotherapy. Clinical and Translational Oncology, 19, 593–598.

Study Purpose

To evaluate the effect and toleration of transmucosal opioid for painful mucositis affecting swallowing.

Intervention Characteristics/Basic Study Process

Retrospective medical chart review was done for data collection for individuals who had opioid maintenance and received fentanyl pectin nasal spray for incidental mucositis pain. Results in patients were compared at different time points when they did and did not use fentanyl pectin nasal spray for incidental breakthrough pain.

Sample Characteristics

  • N: 40   
  • AGE: Mean age = 64.08 years, range = 36-80
  • MALES: 70%  
  • FEMALES: 30%
  • CURRENT TREATMENT: Radiation, combination radiation and chemotherapy
  • KEY DISEASE CHARACTERISTICS: Head and neck cancer, orophyarynx most common site

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Spain

Phase of Care and Clinical Applications

PHASE OF CARE: Active anti-tumor treatment

Study Design

Retrospective observational

Measurement Instruments/Methods

  • Oral intake
  • Prevalence of breakthrough pain
  • Numeric rating scale for pain intensity

Results

After implementation of transmucosal opioid for incidental pain, oral intake improved (p = 0.000). With use of fentanyl pectin nasal spray, intensity of breakthrough pain episodes went from 5.73 (SD = 1.54) to 2.25 (SD = 2.45).

Conclusions

Transmucosal opioids may be helpful in managing incidental pain associated with mucositis, and may facilitate oral nutritional intake.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Measurement/methods not well described

 

Nursing Implications

Due to rapid onset, transmucosal opioid use for incidental pain that interferes with swallowing and oral intake in patients with head and neck cancer may be of benefit. Further well-designed research in this area is warranted.

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