Garcia, M.K., Driver, L., Haddad, R., Lee, R., Palmer, J.L., Wei, Q., . . . Cohen, L. (2014). Acupuncture for treatment of uncontrolled pain in cancer patients: A pragmatic pilot study. Integrative Cancer Therapies, 13, 133–140.
To test the hypotheses that acupuncture would be feasible, safe, and effective adjunct for pain management
Patients were recruited from referrals to a pain management center. Patients received individualized acupuncture treatments one to three times per week. Treatments were provided by two licensed and experienced acupuncturists. The points used in the treatments are described, and standard techniques for point location were used. Needles were left in place for about 25 minutes. Electrical stimulation was added at the discretion of the practitioner. Study measures were obtained at baseline and after the last acupuncture session. Patients were dropped from the analysis if pain control medications were changed during the course of the study.
Single-arm prospective trial
The average number of treatments was eight (range = 2–10) over five weeks excluding drop-outs. 71% of patients received auricular acupuncture and 71% received electroacupuncture. Pain severity and interference scores declined significantly (p < .0011) using the BPI. A significant reduction in both of these aspects was also seen with the MASI (p < .002). Intent-to-treat analysis using the replacement of missing values with group means showed the same results. For 44% of patients, pain medications remained the same as those at baseline. Fewer patients required opioids at follow-up compared to baseline, and the prevalence of use of other medications for pain such as nonopioid analgesics, antidepressants, and other adjuvant medications declined. 87% of patients stated that the course of acupuncture treatment met their expectations very or extremely well. There were no adverse effects of acupuncture reported.
Findings suggest that the use of acupuncture as an adjunctive therapy for chronic pain management is feasible, is safe, and can be beneficial in reducing pain.
Findings suggest that acupuncture treatment as an adjunctive pain management approach can be beneficial for some patients. Interpretation of findings is difficult due to the individualization of the treatment regimen, study design limitations, and the likelihood that there is a placebo effect with acupuncture. For those patients who wish to try acupuncture for pain management, it appears to be feasible and safe when provided by appropriate practitioners.
Garcia, S. (2014). The effects of education on anxiety levels in patients receiving chemotherapy for the first time: An integrative review. Clinical Journal of Oncology Nursing, 18, 516–521.
PURPOSE: To synthesize evidence regarding the effectiveness of education for decreasing anxiety in patients receiving chemotherapy for the first time
PHASE OF CARE: Active antitumor treatment
Three sources were guidelines, two were pilot studies, one was an evidence summary review, one was a systematic review, and one was an expert opinion. Most sources were of poor or fair quality. Not all the studies actually measured anxiety; some measured patient satisfaction. There was no differentiation made between the provision of educational and informational written materials and the provision of psychoeducation or cognitive behavioral therapy interventions.
This review provides minimal actual evidence regarding the effectiveness of educational interventions.
A limited number of actual studies were included, and those included did not all address or measure anxiety.
Patient education prior to receiving chemotherapy is an essential aspect of patient care in providing an informed and empowered patient. The impact of education alone on anxiety is not clear, and this article does not provide substantial evidence or synthesis to clarify this potential effect of educational interventions.
Garcia, J.M., Friend, J., & Allen, S. (2012). Therapeutic potential of anamorelin, a novel, oral ghrelin mimetic, in patients with cancer-related cachexia: A multicenter, randomized, double-blind, crossover, pilot study. Supportive Care in Cancer, 21, 129–137.
To evaluate the effects of anamorelin in patients with cancer-related cachexia
Patients received anamorelin 50 mg/day or placebo for a three-day treatment period. This was followed by a seven-day washout period. After the washout, patients were switched to the opposite intervention. Assessments were done at baseline and at the end of each study period. Patients were stratified according to level of weight loss prior to random assignment to the treatment condition sequence.
The study was a double-blind, placebo-controlled, crossover, randomized controlled trial.
There was no treatment effect on caloric intake. Growth hormone levels were significantly greater when patients received anamorelin compared to placebo (p = 0.005). ASAS total scores improved after three days of anamorelin (p < 0.002). Among individual symptom items, patients reported improved appetite (2.67 points with anamorelin and 0.5 points with placebo, p = 0.011). FACIT-F scores improved after anamorelin compared to placebo (p = 0.018).
Anamorelin was shown to have some positive effects on patients’ symptoms in this small pilot study. Further research is needed to evaluate efficacy.
The study had a small sample size, with less than 30 participants.
This study was too small to enable any conclusions about the efficacy and safety of anamorelin. Further research with a larger sample is needed.
Garcia Gomez, J., Perez Lopez, M. E., Garcia Mata, J., Isla Casado, D., & SEOM (Spanish Society for Medical Oncology). (2010). SEOM clinical guidelines for the treatment of antiemetic prophylaxis in cancer patients receiving chemotherapy. Clinical & Translational Oncology, 12, 770-774.
To update the 2005 Spanish Society of Medical Oncology (SEOM) clinical guidelines for the treatment of chemotherapy-induced emesis and to continue to improve the supportive care of patients with cancer
The Clinical Guideline Working Group, on behalf of the Spanish Society of Medical Oncology (SEOM) Executive Committee, provided expert opinion based on a review of the literature covering patients with cancer receiving chemotherapy.
All patients were in active treatment. This paper has application to antiemetic drugs.
Prevention of CINV can be accomplished through pharmacologic interventions, increasing patients' quality of life. The use of 5-HT3, along with dexamethasone and aprepitant, seems to be the most effective regimen. Although these recommendations are helpful, no insight into cost implications and little discussion of potential side effects of antiemetic treatment were provided. Additionally, the recommendations offered are purely pharmacologic and, thus, only aimed at those with prescriptive authority.
Garcia Gomez, J., Perez Lopez, M.E., Alonso Bermejo, M., Escobar Alvarez, Y., & Garcia Mata, J. (2013). SEOM guide to antiemetic prophylaxis in cancer patients treated with chemotherapy 2013. Clinical & Translational Oncology, 15, 1030–1036.
PHASE OF CARE: Active antitumor treatment
The authors provide tables summarizing the emetogenic potential of common chemotherapy agents, the National Cancer Institute's classification of emesis by intensity and severity, and an algorithm of chemotherapy-induced nausea and vomiting (CINV) prophylaxis. Recommended schedules for the administration of palonosetron and dexamethasone are also provided.
No succinct list of recommendations was provided by the authors. The definition of nausea is also inconsistent with the National Comprehensive Cancer Network's definition. The article describes the different types of CINV, describes the emetogenic potential of agents, and supports an algorithm to select appropriate interventions. The authors do not state their intention outright; however, this document appears to present treatment guidelines for the Spanish Society of Medical Oncology. This guide is written in a clear style and offers straightforward recommendations for the prevention and treatment of CINV. The recommendations are grounded in the evidence, although no explanation of how the evidence was retrieved is provided. It is not possible to tell if research is drawn from a suitable representation of sources to be deemed comprehensive. Forty-three references were cited ranging from 1993 to 2013. It is assumed that the recommendations are applicable towards adults and not pediatrics but this was not stated. Recommendations for refractory and salvage antiemetic therapy are provided, but it is unclear how consensus was reached for these recommendations.
CINV continues to be a serious and debilitating side effect of chemotherapy for patients with cancer. Nurses should be well informed of current recommendations and guidelines for the use of 5HT3s in the prevention and treatment of CINV.
Garavito, A.A., Cardona, A.F., Reveiz, L., Ospina, E., Yepes, A., & Ospina, V. (2008). Colchicine mouth washings to improve oral mucositis in patients with hematological malignancies: A clinical trial. Palliative & Supportive Care, 6, 371–376.
To evaluate the use of colchicine solution in the treatment of mucositis in patients with hematologic malignancies undergoing chemotherapy
Group A (control) used a 9% sodium chloride (NaCl) and water solution. Group B used a colchicine solution of 2 mg dissolved in 500 cc of sterile water starting the first day of symptoms of oral mucositis until the fifth day of the disease (inflammatory phase). Following the fifth day, patients in group B received same as group A. The solution for both groups was prepared fresh every morning. Both groups gargled for two minutes, four times a day while being supervised by a researcher. Twice a day, patients brushed with a soft toothbrush, if possible. During the study, patients were allowed concomitant interventions for oral mucositis (OM), such as systemic antibiotics, antimycotics, antivirials, antiemetics, analgesics, and granulocyte colony-stimulating factor (G-CSF) support. Cryotherapy and other oral mouthwashes were not permitted.
The study was conducted in an inpatient cancer center in Bogota, Columbia.
This study used a single arm, nonrandomized, sequentially enrolled, historical control group.
Colchicine mouthwash may be helpful in reducing the severity and duration of chemotherapy-induced OM.
Further studies are needed to confirm results. This was done in an inpatient setting under direct supervision; these findings may not be applicable in other situations.
Garassino, M.C., Piva, S., La Verde, N., Spagnoletti, I., Iorno, V., Carbone, C., . . . Farina, G. (2013). Randomised phase II trial (NCT00637975) evaluating activity and toxicity of two different escalating strategies for pregabalin and oxycodone combination therapy for neuropathic pain in cancer patients. PloS One, 8(4), e59981.
To evaluate two different dose escalation approaches for the combination of oxycodone and pregabalin
Patients were randomized to receive either 20 mg per day sustained-release oxycodone and escalating doses of pregabalin starting at 50 mg per day, or to pregabalin at 50 mg per day and escalating doses of oxycodone. Patients were observed for 14 days. The primary endpoint of the study was overall analgesia, defined as pain intensity reduction by at least one-third on a numeric rating scale.
Analgesia as defined was achieved in the pregabalin escalation group with a mean dose of 100 mg and in the other group with a mean dose of 60 mg oxycodone. No differences were seen between groups in use of rescue medication, other analgesics, or side effects.
Strategies for managing neuropathic pain with either dose escalation of pregabalin or escalation of sustained-release oxycodone when given in combination produced similar results.
Findings suggest that similar pain management effects can be achieved with either escalation of pregabalin or escalation of oxycodone when given in combination for neuropathic pain. These findings suggest that either approach may provide similar effects and that the approach used can be determined according to relevant patient characteristics and preferences.
Gao, H., Liang, Y., Zhou, N., Zhang, D., & Wu, H. (2011). Aprepitant plus palonosetron and dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving multiple-day cisplatin-based chemotherapy. Internal Medicine Journal, 43, 73-76.
To evaluate the efficacy and safety of aprepitant in combination with palonsetron and dexamethasone in patients receiving three-day cisplatin-based chemotherapy
This was a single-site study conducted in Guangzhou, China.
All patients were in active treatment.
This was a prospective, nonrandomized study.
Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute, version 3.0, was used to assess nausea and safety.
Triple antiemetic medications of aprepitant, palonosetron, and dexamethasone are safe and effective for multiple-day chemotherapy to prevent vomiting. The antiemetic efficacy is maintained during multiple chemotherapy cycles. The regimen was not as effective in preventing nausea.
Using the combination of aprepitant, palonosetron, and dexamethasone is effective in decreasing the incidence of chemotherapy-induced nausea and vomiting (CINV) in multiple-day chemotherapy regimens with low incidence of toxicity. Control of the symptom of nausea remains problematic.
Gao, L., Yang, Y.J., Xu, H.Y., Zhou, J., Hong, H., Wang, Y.L., & Li, D.C. (2014). A randomized clinical trial of nerve block to manage end-stage pancreatic cancerous pain. Tumour, 35, 2297–2301.
To determine the effectiveness of nerve blocks to control pain in patients with end-stage pancreatic cancer pain
Patients were randomized to two groups, the sham and nerve block groups. Visual Analog Scale (VAS) pain scores, pain duration, reduction of other analgesics, and quality of life scores (measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30]) were obtained before and three months after intervention.
Sham-controlled, randomized, controlled trial
This study presents a potential additional intervention in combination with pain medication in patients with end-stage pancreatic cancer-associated pain. Additional potential benefits could be the improvement of physical and emotional function, fatigue, insomnia, and loss of appetite. This study would have to be replicated with a larger sample size to prove efficacy.
This type of therapy presents a potential intervention in combination with pain medication for pain control in end-stage pancreatic cancer based on this randomized, controlled trial. After-care of a patient with a nerve block would require training. An assessment of the adjustment of other medicinal treatments would be required at baseline in this intervention.
Ganz, P. A., Greendale, G. A., Petersen, L., Zibecchi, L., Kahn, B., & Belin, T. R. (2000). Managing menopausal symptoms in breast cancer survivors: results of a randomized controlled trial. Journal of the National Cancer Institute, 92, 1054-1064.
This study intended to test the effectiveness of a comprehensive menopausal assessment (CMA) on symptom relief, quality of life, and sexual functioning.
Participants were randomized by age (≤55 and >55) and tamoxifen use (current vs. not used). The CMA was delivered by a trained nurse practitioner with a specialty in family and women’s health over a 4-month period and focused on structured symptom assessment of hot flashes, vaginal dryness, and stress urinary incontinence. After assessment, patients were provided with individualized education and counseling, psychosocial support, referrals, and individualized follow-up. Specific pharmacologic and behavioral interventions for the target symptoms were implemented to control symptoms based on treatment protocols developed by the NP and the study physician. The intervention group returned for a 2-month follow-up visit. The usual care group received a telephone call 2 months after baseline to ask about therapies used to manage their symptoms. Data was collected at baseline and 4 months. The usual care group was then able to take part in the CMA but no further data was collected.
PHASE OF CARE: Late effects and survivorship
This was a randomized, controlled trial.
97% of women in the study reported hot flashes at baseline, with no difference between groups. There was a significant difference in the menopause symptom scale (p=.0004), with women in the intervention group showing the most improvement in symptoms. There was no difference between groups in QOL (p=.77). The CMA group had significantly better sexual functioning at follow-up compared to the usual care group (p=.02). No specific data on improvement in hot flashes was provided. Only the overall symptom scale was reported.
CMA is an effective intervention to improve/reduce the number of menopausal symptoms in breast cancer survivors and to improve sexual function for these women.
Limitations of the study included:
A nurse-led intervention to target menopausal symptoms is an effective way to reduce these symptoms in women who are survivors of breast cancer. However, the intervention may be too expensive or impractical given the training requirements of the intervention nurse and institutional guidelines on billable appointments.