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.
Ganti, B.R., Marini, B.L., Nagel, J., Bixby, D., & Perissinotti, A.J. (2017). Impact of antibacterial prophylaxis during reinduction chemotherapy for relapse/refractory acute myeloid leukemia. Supportive Care in Cancer, 25, 541–547.
To evaluate the effects of prophylaxis with levofloxacin in relapsed/refractory acute myeloid leukemia (AML)
Data were obtained from medical records of patients with relapsed or refractory AML admitted from 2006–2015. Standard levofloxacin prophylaxis was begun in 2013 with 500 mg once daily on day 1 of chemotherapy and continued until neutrophil recovery. Cohorts who received levofloxacin were compared to a cohort that did not receive prophylaxis.
PHASE OF CARE: Active antitumor treatment
Retrospective cohort comparison
Febrile neutropenia (FN) was defined as an oral temperature of 38.3 C or greater with and absolute neutrophil count less than 500 cells/mm3
A lower rate of bacteremia existed in the prophylaxis group, but the difference was not significant. The time to onset of bacteremia from onset of neutropenia was delayed in the prophylaxis group compared to others (p = 0.012). No differences in drug-resistant organisms existed between cohorts, or in the incidence of FN. In the prophylaxis group, the frequency of gram-negative organism–related infections was lower.
Levofloxacin prophylaxis reduced the number of overall infections and the prevalence of gram-negative infections in patients being treated for relapsed or refractory AML.
The findings suggest that antibiotic prophylaxis is beneficial for patients undergoing re-induction chemotherapy for relapsed or refractory AML.
Gandemer, V., Le Deley, M., Dollfus, C., Auvrignon, A., Bonnaure-Mallet, M., Duval, M., … Schmitt, C. (2007). Multicenter randomized trial of chewing gum for preventing oral mucositis in children receiving chemotherapy. Journal of Pediatric Hematology/Oncology, 29, 86–94.
Patients chewed five to six pieces of fluoride-containing, sugar-free gum, sweetened with xylitol per day for 20 minutes per piece from the first day of chemotherapy to three days after course of treatment. Both groups practiced standard oral care, consisting of brushing teeth with a soft toothbrush and rinsing with sodium bicarbonate rinse.
The study was conducted between March 1999 and December 2002.
This was a randomized, controlled trial.
Researchers recorded the WHO grade of mucositis within first 21 days, time to development of grade 3–4 mucositis, incidence of any grade of mucositis, incidence of pain using a 70-point visual analogue scale, number of days of total parenteral nutrition, incidence of abdominal symptoms, and incidence of septicemia.
No significant differences were found between arms for severe mucositis endpoints.
Patients receiving less toxic regimens had a decrease in WHO grade 1–4 oral mucositis of 49% in the gum group and 72% in the control group (p = 0.03).