Ravasco, P., Monteiro-Grillo, I., Marques-Vidal, P., & Camilo, M. (2005). Dietary counseling improves patient outcomes: A prospective, randomized, controlled trial in colorectal cancer patients undergoing radiotherapy. Journal of Clinical Oncology, 23, 1431–1438.
To investigate the impact of dietary counseling or nutritional supplements on morbidity and quality-of-life outcomes in patients with cancer during and three months after radiotherapy (RT)
Group 1 patients received individualized dietary counseling based on regular food groups. Group 2 patients consumed two cans of a high-protein liquid supplement per day in addition to their usual diet. Group 3 patients (control) were instructed to maintain their ad lib intake.
This prospective study design allowed for comparison of the effects of the interventions across the study arms over time. Evaluation took place at three points: baseline, at the end of RT, and three months later. Several types of outcome variables were measured, including nutritional status indicators.
The study was a prospective, randomized, controlled trial.
Protein 3 energy intake: at three-month time point, group 1 maintained nutritional intake and groups 2 and 3 returned to baseline. After RT and at three months, rates of anorexia, nausea and vomiting, and diarrhea were higher in group 3. At RT completion, 211 QOL function scores improved in group 1, 3 out of 6 function scores improved in group 2, and all scores worsened in group 3.
Researchers concluded that both interventions positively influenced outcomes. Three months after RT, dietary counseling was the only intervention to sustain a significant impact on patient outcomes.
This study examined the effects of individualized dietary counseling in a high-risk group. Whether individualized dietary counseling in other cancer groups will produce the desired outcome of increased appetite needs to be examined.
Raulji, C.M., Clay, K., Velasco, C., & Yu, L.C. (2015). Daily bathing with chlorhexidine and its effects on nosocomial infection rates in pediatric oncology patients. Pediatric Hematology and Oncology, 32, 315–321.
To determine the effect of daily bathing with chlorhexidine on nosocomial infection rates
Nosocomial infection rates were compared before and after the implementation of a daily chlorhexidine bathing. A solution of 4% chlorhexidine gluconate was diluted in 10 parts water to 1 part cleanser and was used to rinse all body surfaces except the face.
The infection rate was lower in the study group compared to historical controls only in those aged 12–21 years (p = 0.008). This age group also showed a higher prevalence of neutropenia (p = 0.039) in the study group. Overall, no significant differences existed in infection rates between study groups.
The results did not show an overall reduction in infections with daily chlorhexidine bathing, although some benefit was seen among older adult patients.
The findings did not provide definitive evidence that daily chlorhexidine bathing reduces hospital-acquired infections; however, the rates among older adult patients, who also had a higher prevalence of neutropenia, improved. Chlorhexidine bathing is a simple and potentially low cost intervention that may have some benefit for neutropenic patients. Further research in this intervention is warranted.
Rauck, R.L., Tark, M., Reyes, E., Hayes, T.G., Bartkowiak, A.J., Hassman, D., . . . Howell, J. (2009). Efficacy and long-term tolerability of sublingual fentanyl orally disintegrating tablet in the treatment of breakthrough cancer pain. Current Medical Research and Opinion, 25, 2877–2885.
To evaluate the effect of sublingual fentanyl on breakthrough cancer pain in opioid-tolerant patients; to assess how well patients tolerate sublingual fentanyl
The study included an open-label titration phase, a two-week double-blind efficacy phase, and a long-term open-label safety phase of up to 12 months duration. Sublingual orally disintegrating tablet (ODT) fentanyl was given at 100 mcg and titrated in the open-label phase to a maximum dose of 800 mcg until patients identified a single effective and tolerable dose. In the double-blind phase, patients received seven doses of the study drug and three doses of placebo. The study drug and placebo were identical in appearance. Patients took doses in a randomly assigned sequence. Rescue medication could be administered if needed after two hours. Patients were followed on a daily basis by telephone to monitor use of the study and rescue medications and the incidence of adverse events during the titration phase. Thereafter, investigators monitored patients in person on a monthly basis and at two weeks after monthly by-telephone evaluations. Patients maintained an electronic daily diary. Pain intensity and pain relief were recorded immediately prior to treatment and at 10, 15, 30, and 60 minutes after use.
Randomized placebo-controlled phase III trial
Overall, patients received the study drug for an average of 51 days. Median dose of ODT fentanyl was 600 mcg. A median of three doses were taken per day. The most common treatment-related complications were nausea (12.2%), vomiting (5.3%), and somnolence (4.6%). One patient developed stomatitis, which may have been related to the study drug. Sublingual ODT fentanyl was significantly more effective (p < 0.006) than placebo at all time points and was most effective at 60 minutes (p = 0.0004). Pain relief was significantly better with ODT fentanyl than with placebo (p = 0.0007) at 15 minutes after use and at 30 and 60 minutes.
Sublingual ODT fentanyl was effective in the management of breakthrough pain, and patients tolerated the medication well.
In this study ODT fentanyl was effective in treating breakthrough pain; therefore, ODT fentanyl may be an appropriate means to manage this problem. The study reported one case of stomatitis, which may have been related to this drug. Nurses should be aware of the potential of stomatitis occurring with a patient's use of ODT fentanyl. The follow-up period in the present study was relatively short. Longer use of ODT fentanyl may pose greater risk of stomatitis.
Rauck, R., Reynolds, L., Geach, J., Bull, J., Stearns, L., Scherlis, M., . . . Dillaha, L. (2012). Efficacy and safety of fentanyl sublingual spray for the treatment of breakthrough cancer pain: A randomized, double-blind, placebo-controlled study. Current Medical Research and Opinion, 28(5), 859–870.
To assess the efficacy of and determine the side effects related to the use of sublingual fentanyl spray for the treatment of breakthrough cancer pain
The study involved an open-label titration period followed by a treatment period of up to 26 days. The primary efficacy measures were summed pain intensity difference at 30 minutes (SPID30), total pain relief at 30 minutes (TOTPAR30), and patient global evaluation of medication study at 30 minutes. Efficacy was observed 5–60 minutes postdose and for side effects throughout. Patients were randomly assigned to the study drug or placebo. After the treatment period, a follow-up assessment was done 30 days after treatments. The fentanyl sublingual spray was titrated from 100 mcg to up to 1600 mcg until an effective dose was reached. Rescue medication was the medication the patient had for breakthrough pain before the study.
Randomized, double-blind, placebo-controlled study
Of 130 patients, 98 entered the double-blind period. Relative to placebo, fentanyl sublingual spray significantly improved mean SPID scores from 5 minutes (p = 0.0219) through 60 minutes (p < 0.0001), including the primary endpoint at 30 minutes (p < 0.0001). The most frequent effective dose was 800 mcg. Side effects reported were nausea, hyperhidrosis, and peripheral edema; however, investigators did not consider any of these effects to be related to the treatment. Side effects occurred in about 4% of patients. Degree of pain relief and speed of pain relief were significantly higher with the study drug (p < 0.0001).
In this study fentanyl sublingual spray was well tolerated and effective in treating breakthrough of cancer pain.
Proper patient assessment prior to recommendation of the treatment is highly important. Oral hygiene is important during treatment with fentanyl spray. Keep an eye on side effects to ensure the comfort of the patient.
Rauck, R., North, J., Gever, L.N., Tagarro, I., & Finn, A.L. (2010). Fentanyl buccal soluble film (FBSF) for breakthrough pain in patients with cancer: A randomized, double-blind, placebo-controlled study. Annals of Oncology: Official Journal of the European Society for Medical Oncology/ESMO, 21(6), 1308–1314.
To evaluate the efficacy of fentanyl buccal soluble film (FBSF), at doses of 200–1200 mcg, in the management of breakthrough pain (BTP) in patients with cancer who are receiving ongoing opioid therapy
In phase 1, patients were screened, for up to one week, to assess tolerance of FBSF. In phrase 2, the titration phase, patients started with 200 mcg dose that was increased in a stepwise fashion (200, 400, 600, 800, 1200 mcg) until the patient experienced pain relief. Patients were discontinued from the study if a satisfactory dose could not be determined. If a satisfactory dose was achieved for two BTP episodes, patients proceeded to the double-blind phase. The double-blind phase lasted up to two weeks. Each patient received nine doses of FBSF (six of study medication and three of placebo). A computer determined the order of administration. Patients were allowed to use usual rescue medication if they did not receive adequate pain relief in 30 minutes. Study medication was allowed every four hours.
Randomized placebo-controlled, double-blind, multiple-crossover study
FBSF was more effective than placebo for the treatment of breakthrough pain in patients with cancer. The treatment was well tolerated.
FBSF shows favorable and safe results for the treatment of breakthrough pain, but the treatment remains investigational.
Rath, H.M., Ullrich, A., Otto, U., Kerschgens, C., Raida, M., Hagen-Aukamp, C., . . . Bergelt, C. (2016). Psychosocial and physical outcomes of in- and outpatient rehabilitation in prostate cancer patients treated with radical prostatectomy. Supportive Care in Cancer, 24, 2717–2726.
To examine the effects of inpatient and outpatient rehabilitation (i.e., physical therapy, psycho-oncological treatment, patient education, medical treatment, group sessions) on quality of life and psychosocial outcomes
Patients who had radical prostatectomy participated in inpatient and/or outpatient rehabilitation within 14 days after completion of acute oncology treatment
PHASE OF CARE: Transition phase after active treatment
Subjects reported similar cognitive function scores at baseline and one year after rehabilitation. Cohen’s d was 0.51 and 0.54 respectively (both p < 0.001). They reported higher cognitive function at the end of rehabilitation (F [df 1.8, 1238.2] = 138.1, p < 0.001). Quality of life was higher at a one-year follow-up (p < 0.001). Anxiety was lower at the end of rehabilitation for inpatient and outpatient rehabilitation groups (p < 0.001). Depression was lower at end of rehabilitation and sustained at a one-year follow-up (p = 0.008).
The effect of structured rehabilitation on outcomes in this study was unclear, and no clear differences in outcomes based on whether patients received inpatient or outpatient rehab services were observed.
Rehabilitation, whether provided in an inpatient or outpatient setting, improved patients’ perception of quality of life, depression, anxiety, and cognitive function by the end of rehabilitation. Perceived improvements in quality of life and depression persisted at one year after treatment.
Rastogi, M., Khurana, R., Revannasiddaiah, S., Jaiswal, I., Nanda, S.S., Gupta, P., . . . Bhatt, M.L. (2016). Role of benzydamine hydrochloride in the prevention of oral mucositis in head and neck cancer patients treated with radiotherapy (> 50 Gy) with or without chemotherapy. Supportive Care in Cancer. Advance online publication.
To evaluate the role of benzydamine in the prevention of mucositis in patients receiving more than 50 Gy of radiation therapy
Patients were stratified according to receiving radiotherapy or radiotherapy and chemotherapy, and then randomly assigned to control or treatment with benzydamine. All patients were advised to use saline mouth rinses, and those in the treatment group also used 0.15% benzydamine hydrochloride rinse. Both groups were to rinse and gargle with the mixture four to six times daily. Patients were examined weekly until four weeks after completion of the treatment.
PHASE OF CARE: Active antitumor treatment
Randomized, controlled trial
Patients receiving radiotherapy alone who used benzydamine had a lower prevalence of grade 3 mucositis compared to controls (p = 0.038); however, control patients receiving only radiotherapy also had a longer duration of radiation treatment (p = 0.042, 56 versus 44 days). No significant difference in mucositis outcomes occurred among those receiving both chemotherapy and radiation. Control patients in this group had a longer duration of radiation therapy.
Benzydamine prophylaxis appears to be effective to reduce the severity of oral mucositis among patients receiving radiotherapy alone for head and neck cancer. Effects for patients receiving both chemotherapy and radiation therapy were not seen.
Oral rinses with benzydamine were helpful to reduce the prevalence of severe mucositis among patients receiving radiation therapy for head and neck cancer. It is unclear if benzydamine can also be helpful for patients receiving combination chemotherapy and radiation therapy.
Rasmussen, C.L., Olsen, M.K., Johnsen, A.T., Petersen, M.A., Lindholm, H., Andersen, L., . . . Pedersen, L. (2015). Effects of melatonin on physical fatigue and other symptoms in patients with advanced cancer receiving palliative care: A double-blind placebo-controlled crossover trial. Cancer, 121, 3727–3736.
To determine if oral melatonin administered at night would reduce fatigue and improve sleep in patients with advanced cancer treated in a palliative care facility
This was a two-part trial. In part one, patients received either melatonin (20 mg) or placebo followed by a washout of two days, then crossed over and received the opposite of the first week of treatment. Part two was an open-label study of patients who completed part one and chose to continue melatonin. Study questionnaires were completed at the beginning and end of each treatment period (days 1, 7 ,10, and 17). In part two, study measures were obtained weekly. Patients were randomly assigned to the order in which they received melatonin or placebo.
No significant differences were noted in patient outcomes between the placebo and melatonin groups.
Melatonin administration did not improve fatigue, insomnia, or other symptoms in patients with advanced cancer.
This study did not show any improvement in fatigue or sleep as a result of melatonin.
Rashad, U.M., Al-Gezawy, S.M., El-Gezawy, E., & Azzaz, A.N. (2009). Honey as topical prophylaxis against radiochemotherapy-induced mucositis in head and neck cancer. Journal of Laryngology and Otology, 123, 223–228.
Patients smeared 20 mL of pure, natural honey (acidic with a pH of about 3.9) on the inside of their mouths 15 minutes before, 15 minutes after, and six hours after radiation. Patients rinsed honey on oral mucosa and then swallowed it slowly. Patients were randomized to the treatment or control group. Patients also used benzydamine HCL plus supportive oral care measures. A solubility-reducing factor present in honey can activate in the absence of saliva.
Razavi, D., Allilaire, J.F., Smith, M., Salimpour, A., Verra, M., Desclaux, B., . . . Blin, P. (1996). The effect of fluoxetine on anxiety and depression symptoms in cancer patients. Acta Psychiatria Scandinavica, 94, 205–210.
This trial randomized patients to two arms: one group received fluoxetine, and the other group received placebo for five weeks.
Patients with cancer (N = 115) were randomized to two arms: fluoxetine treatment (n = 45) versus placebo (n = 46) for five weeks.
A randomized, controlled, double-blinded trial design was used.
Response rate (HADS) score < 8 after five weeks was not significantly higher in the fluoxetine group compared to the placebo group. There was significant decrease in mean scores on the SCL90-R in the fluoxetine group. There was no difference between groups on MADRS, HAS, or SQOLI.
Lower scores on subscales of the SQL90-R may reflect changes in anxiety levels between groups.
The authors did not mention power of effect size.