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).
Gamelin, L., Boisdron-Celle, M., Delva, R., Geurin-Meyer, V., Ifrah, N., Morel, A., & Gamelin, E. (2004). Prevention of oxaliplatin-related neurotoxicity by calcium and magnesium infusions: A retrospective study of 161 patients receiving oxaliplatin combined with 5-fluourouracil and leucovorin for advanced colorectal cancer. Clinical Cancer Research, 10(12, pt. 1), 4055–4061.
Participants in the treatment group received infusions of calcium gluconate and magnesium sulfate (1 g) before and after oxaliplatin. The chemotherapy protocol consisted of combination oxaliplatin, 5-fluourouracil (5-FU), and leucovorin. Three regimens of oxaliplatin were used: 85 mg/m² every two weeks, 100 mg/m² every two weeks, or 130 mg/m² every three weeks.
A total of 161 patients were enrolled in the study, with 96 placed in the treatment group and 65 in the control group.
The study had a retrospective design.
Toxicity was graded every one to two weeks by staff according to the National Cancer Institute's Common Terminology Criteria for Adverse Events and an oxaliplatin-specific neurotoxicity scale that assessed paresthesias.
Paresthesias, trismus, cramps, limb pain, and diarrhea were significantly less frequent in the treatment group. Pharyngolaryngeal dysesthesia were never reported in the treatment group versus 9% in the control group. In addition, less grade 3 toxicity was reported in the treatment group compared to the control group. At the end of oxaliplatin therapy, 65% of participants in the treatment group had no evidence of chemotherapy-induced peripheral neuropathy (CIPN) compared to 37% in the control group. By the end of treatment, 20% of patients in the treatment group showed evidence of CIPN versus 45% in the control group. Patients with grade 2 or 3 neurotoxicity at the end of treatment with oxaliplatin (85 mg/m²) recovered more rapidly from CIPN than those in the control group.
Gamborg, H., Riis, J., Christrup, L., & Krantz, T. (2013). Effect of intraoral and subcutaneous morphine on dyspnea at rest in terminal patients with primary lung cancer or lung metastases. Journal of Opioid Management, 9, 269–274.
To compare the effectiveness of orally administered red morphine drops (RMD) and subcutaneous morphine (SCM) in patients with advanced lung cancer
Patients were randomized to two groups. Group 1 received oral RMD and a subcutaneous injection of isotonic saline. Group 2 received a placebo oral RMD and a subcutaneous injection of morphine. All injections were given in the leg in a location without edema. Patients were instructed to hold the RMD or placebo RMD solution in their mouths as long as possible before swallowing. The study preparations included a) morphine hydrochloride at 2 g, ethanol 96% at 5 g, cochenille tincture PhD.48 10 g, purified water up to 100 g (one drop corresponded to 0.6 mg morphine), b) ethanol 96% at 5 g, cochenille tincture PhD.48 10 g and purified water up to 100 g, c) injectable morphine 20 mg/ml, and d) isotonic saline. Measurements were taken at baseline and five, 10, 15, 20, 30, and 60 minutes after medication administration. Patients were not allowed to take any opioid within four hours prior to the experiment.
Double-dummy randomized, controlled trial
There was no significant difference in dyspnea between the two groups. Both RMD and SCM showed a significant decrease in dyspnea (time p = 0.0451, and treatment p < 0.0001). In addition, RMD and SCM were associated with significant decreases in pulse rate (p = 0.0410). Although it was not statistically significant, patients receiving SCM showed a more rapid decline in dyspnea. Patients in the RMD group received 3.3%–8.6% of their total 24-hour opioid dose. Patients in the SCM group received 1.5%–5.5% of their total 24-hour opioid dose.
Both RMD and SCM improved dyspnea in terminally ill patients.
RMD is a reasonable alternative to SCM and should be considered as part of patient preference at the end of life. Subcutaneous administration may provide more rapid relief. It is noteworthy that opioid use relieves dyspnea for patients receiving regular opioids for pain management. The most effective dosage of RMD is not yet known. Additional research to understand the pharmacokinetics of RMD is needed.
Galway, K., Black, A., Cantwell, M., Cardwell, C.R., Mills, M., & Donnelly, M. (2012). Psychosocial interventions to improve quality of life and emotional wellbeing for recently diagnosed cancer patients. Cochrane Database of Systematic Reviews, 11, CD007064.
To assess the effects of psychosocial interventions on quality of life and mood symptoms in patients diagnosed with cancer within the past 12 months
Multiple phases of care
Findings suggest that psychosocial interventions have a positive impact on quality of life among newly diagnosed patients with cancer. Psychoeducational interventions and nurse-delivered interventions demonstrate a small significant effect across combined trials. Overall evidence does not indicate that individual psychosocial interventions are effective at improving the mood- and quality-of-life–related symptoms of patients newly diagnosed with cancer.
A small number of studies in meta-analysis related to mood changes. Effect sizes in mood changes were small, and study samples comprised high heterogeneity, demonstrating that findings should be interpreted with some caution in terms of clinical relevance.
The fact that nurse-delivered psychosocial interventions demonstrated a positive and statistically significant effect is promising, although the effect size was small. This finding provides some support for interventions delivered by nurses rather than by other healthcare professionals. Other studies have reported this finding. Nurses may be uniquely positioned to provide such interventions: Their knowledge base includes both physiologic and psychosocial components of the cancer experience, and individual interventions can simultaneously and effectively address physical and psychosocial symptom management. The findings of this study provide general support for the effectiveness of psychoeducational interventions.
Galvão, D. A., & Newton, R. U. (2005). Review of exercise intervention studies in cancer patients. Journal of Clinical Oncology, 23, 899–909.
The MEDLINE database was searched through June 2004 to identify experimental and quasiexperimental studies of exercise (cardiovascular and/or resistance training) during and following cancer treatment.
Twenty-six published studies, reflecting 18 experimental or quasiexperimental trials of exercise during cancer treatment and eight studies of exercise after cancer treatment, were identified. Of the 18 trials during treatment, 14 used some type of cardiovascular training; two used mixed training with cardiovascular, resistance, and flexibility exercise; and two applied a structured resistance training program. Of the eight trials of exercise after cancer treatment, all used cardiovascular or cardiovascular plus resistance training. The duration of the intervention ranged from two to 28 weeks, and the frequency of the exercise intervention ranged from daily to two times per week.
Outcomes were fatigue, health-related quality of life, symptom distress, psychological distress, body composition, physical exercise capacity (maximal oxygen consumption), immunologic parameters, and muscle strength. Treatment evaluated cardiovascular and/or resistance exercise.
Five of 18 studies of exercise during cancer treatment specifically found improvements in fatigue, and most of these studies were in women with breast cancer. Of note, a trial of resistance training three times per week in men with prostate cancer undergoing androgen depletion therapy showed improvements in fatigue after a 12-week program. Of the eight studies of exercise following cancer treatment, none reported statistically significant improvements in fatigue, but there were improvements in functional status, quality of life, psychological distress, strength, and capacity.
Although recent evidence supports the use of resistance exercise during cancer management as an exercise mode to counteract adverse effects of the disease and treatment, most of the studies were conducted using cardiovascular training. Promising results in terms of fatigue and other outcomes of a short-term resistance exercise program on patients diagnosed with prostate cancer and undertaking androgen-depletion therapy have been reported.
Galiano-Castillo, N., Cantarero-Villanueva, I., Fernandez-Lao, C., Ariza-Garcia, A., Diaz-Rodriguez, L., Del-Moral-Avila, R., & Arroyo-Morales, M. (2016). Telehealth system: A randomized controlled trial evaluating the impact of an internet-based exercise intervention on quality of life, pain, muscle strength, and fatigue in breast cancer survivors. Cancer. Advance online publication.
To evaluate the effectiveness of a the telehealth-delivered exercise intervention on symptoms among breast cancer survivors
Patients were randomized to the telehealth intervention or usual care. After baseline assessment, those in the study group received instructions on how to access the private area of the system. The intervention consisted of three sessions per week of exercise following recommendations of the American College of Sports Medicine for cancer survivors. Each session was delivered online. The system allowed participants to send messages and set up video conferencing, participants to write questions or comments, and research staff to comment and monitor performance remotely. Participants received phone calls from research staff if needed. The intervention lasted eight weeks. Usual care patients received basic written recommendations for exercise. After six months, they were offered the opportunity to participate in the telehealth program. Assessments were done at baseline, at completion, and at six months.
After the intervention, the telehealth group reported lower pain severity (p = 0.001) and interference (p = 0.045). The telehealth group reported improved total fatigue perception compared to controls (p = 0.001). This improvement was maintained at the six month follow-up (ES d = –0.75, p = 0.002). Adherence rate for exercise sessions was 93.9%. Muscle strength and quality of life (QOL) were also improved in the telehealth group compared to controls. There were no technical issues or adverse effects of the intervention observed.
An online exercise and interaction approach was effective in reducing pain and fatigue and improving QOL and muscle strength. The program had good patient adherence.
The online delivery of an interactive exercise intervention was shown to be effective. An Internet-based intervention may be a useful alternative to traditional approaches to deliver such interventions, particularly in the setting of barriers such as distance and time. The comparative costs for staff time to deliver and maintain this type of intervention need to be evaluated.