Allison, P. J., Edgar, L., Nicolau, B., Archer, J., Black, M., & Hier, M. (2004). Results of a feasibility study for a psycho-educational intervention in head and neck cancer. Psycho-Oncology, 13, 482–485.
Participants were offered the Nucare coping strategies program (teaches people to cope with cancer, based on the McGill Model of Nursing) in one of three formats: small group; one on one; and one on one with therapy (home version with materials). There was no control arm. Data were taken at baseline and two and three months following the intervention outcome. Participants chose the study arm.
This was a nonrandomized, no control pilot, feasibility study for delivery in which participants wanted the intervention.
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30)
Fatigue was improved in 17 (38%) patients overall, and improvement was equal in self (home) to that seen with the use of a therapist.
Allard, P., Lamontagne, C., Bernard, P., & Tremblay, C. (1999). How effective are supplementary doses of opioids for dyspnea in terminally ill cancer patients? A randomized continuous sequential clinical trial. Journal of Pain and Symptom Management, 17(4), 256–265.
The objective of this study was to compare the efficacy of supplemental, oral, and parenteral opioid doses consisting of either 25% or 50% of the equivalent 4-hour opioid dose (i.e., total 24-hour opioid dose divided into 4-hour portions) in patients already receiving opioids on a regular basis.
The study reported on a sample of 33 terminally ill patients with cancer and dyspnea at rest who already were receiving opioids.
The study was conducted in three separate palliative care centers in Quebec, Canada.
The study was a randomized, double-blind, continuous sequential controlled trial.
Dyspnea intensity on the visual analog scale and respiratory rate were measured at baseline, 30, 60, 120, 180, and 240 minutes after dose.
The overall treatment effect, as measured by dyspnea intensity and respiratory frequency, was not significantly different for 25% or 50% of the equivalent four-hour opioid dose. A significant (p < 0.0001) decrease was found in pre- and post-dyspnea intensity. Dyspnea decrease was inverse to baseline dyspnea intensity (i.e., low dyspnea at baseline had greater decrease in dyspnea intensity whereas high dyspnea at baseline had less decrease).
Because 25% and 50% doses had the same effect, a supplementary dose of 25% of the equivalent four-hour opioid dose is recommended to reduce dyspnea for as long as four hours.
Alicino, I., Giglio, M., Manca, F., Bruno, F., & Puntillo, F. (2012). Intrathecal combination of ziconotide and morphine for refractory cancer pain: A rapidly acting and effective choice. Pain, 153, 245–249.
To assess the efficacy and safety of an intrathecal (IT) combination of ziconotide and morphine in malignant pain refractory to high doses of oral uploads
Visual anolog scale of pain intensity (VASPI) scores and Karnofsky Performance Status Scale (KPSS) scores were recorded for each patient at the initial visit. An IT catheter was place under fluoroscopy with aseptic technique, with a 1 g dose of cefazolin to prevent infection. Patients continued their long-term oral morphine until the IT infusion started and asked to start a short-acting morphine dose of 10 or 30 mg if needed. VASPI and KPSS scores, vital signs, electrocardiograms (ECGs), and adverse events were evaluated at day 2, day 7, and weekly up to day 28. The ziconotide infusion titration was started at 2.4 micrograms per day and increased by 1.3 micrograms per day at day 7 in patients with a VASPI score greater than 30 at rest. IT morphine dose was calculated based on their daily dose, an oral-IT ratio of 400:1. Increases in IT morphine were based on the oral morphine consumption. Doses were adjusted for adverse events and analgesic effect. The mean VASPI score, mean change in VASPI score, and mean percentage change from baseline to each visit and to the last observation was calculated.
Prior to the study, participants had persistent pain for a mean of six months SD = two months) and took a mean daily dose of 320 mg per day (SD = 80 mg) of systemic opioids. The mean VASPI score at rest was 90 mm (SD = 7 mm), with a mean incidental VASPI score of 99 mm (SD = 3 mm), and a mean KPSS of 59 (SD = 10. 4). Patients had severe opioid-related side effects that did not permit an increase in systemic opioids. IT therapy started with morphine 0.82 mg per day (SD = 0.36 mg) with ziconotide 2.4 mcg per day. On day 2, the mean VASPI score at rest decreased to 55 mm (SD = 12 mm), a significant reduction (p < .001). For five patients, an increase in morphine was necessary. On day 7, the mean VASPI at rest was 44 mm (SD = 11 mm), a significant decrease (p < .001). Four patients had an increase in ziconotide daily. On day 28, mean VASPI was 34 (SD = 13), a significant decrease (p < .001). Eighty percent of patients reached the effective dose for morphine and ziconotide within two weeks. Only five patients survived until the third month with good pain control. The maximum dose of ziconotide was 5.2 mcg per day, and the maximum dose of morphine was 2 mg per day. Four patients developing adverse effects attributed them to the study drugs. Changes in serum creatinine kinase levels and vital signs were not significant. No infections correlated with IT catheter placement.
IT therapy with ziconotide and morphine is a helpful strategy in controlling malignancy-related pain refractory to high dose of systemic uploads. Using both drugs appears to have a synergistic effect and may benefit patients with cancer. Lower doses of each drug may be utilized with few adverse events and side effects. However, this study has a few limitations that impair generalizability, may have a potential for bias, and may not have captured the risk to patients being treated longer than a few months.
Combination IT ziconotide and morphine in patients with cancer with nociceptive bone pain refractory to systemic opioids may be a helpful strategy for controlling pain. Low doses of ziconotide are required with the use of morphine, as compared to higher doses of ziconotide alone. In turn, less adverse events may be observed with potentially better pain control. When considering drug stability, alternative agents for pain in combination with ziconotide may be considered in place of morphine, as pump refills are required with lower-stability agents.
Alibhai, S.M., Durbano, S., Breunis, H., Brandwein, J.M., Timilshina, N., Tomlinson, G.A., . . . Culos-Reed, S.N. (2015). A phase II exercise randomized controlled trial for patients with acute myeloid leukemia undergoing induction chemotherapy. Leukemia Research, 39, 1178–1186.
To determine if a multimodal exercise program for patients during induction chemotherapy is feasible, safe, and beneficial for fatigue, quality of life, and fitness
Patients were randomized to the exercise or usual care groups. Usual care generally included suggestions to walk on a regular basis, without further instruction. Those in the exercise group were approached 4–5 days per week during hospital admission to participate in light-to-moderate–intensity exercise for 30–60 minutes. Exercise sessions included combined aerobic, resistance, and flexibility training. Aerobic intensity was encouraged at an exertion equivalent to 50%–75% of heart-rate reserve. The resistance exercises targeted large muscle groups using resistance bands and free weights. Flexibility was incorporated into each session via static stretching. Exercise sessions were directly supervised by a certified exercise physiologist. Study assessments were completed at baseline, post induction, and within two weeks of discharge, post cycle 2 (4–6 weeks post discharge).
Exercise group participants completed 514.2 minutes of exercise on average during an average admission of 36.5 days. The most common reported reason for not exercising was fatigue. Adherence to exercise sessions was 54%. Control group patients exercised an average of 510.4 minutes over 35.8 days. Participants in both groups demonstrated an improvement in global quality of life. Fatigue scores improved only in the exercise group, with a between group difference of 3.6 points, which was not statistically significant. The six-minute walk improved in both groups but improved significantly more in the exercise group (p = 0.005). No significant adverse event occurred. During over 1,000 patient days of observation, four musculoskeletal events were reported. No differences existed between groups in length of stay or other resource utilization.
This study demonstrated that the provision of an exercise program is feasible for patients during induction chemotherapy and may help manage fatigue in these patients. Patients who participated in the multimodal exercise program demonstrated improved physical fitness.
Participation in an exercise program of moderate intensity was shown to be feasible for patients who were hospitalized and receiving induction chemotherapy for AML.
Alibhai, S.M., O'Neill, S., Fisher-Schlombs, K., Breunis, H., Timilshina, N., Brandwein, J.M., . . . Culos-Reed, S.N. (2014). A pilot phase II RCT of a home-based exercise intervention for survivors of AML. Supportive Care in Cancer, 22, 881–889.
To examine the feasibility (recruitment, retention, and adherence), preliminary efficacy, and safety of a 12-week, home-based exercise program for middle-aged and older acute myeloid leukemia (AML) survivors
Phase II randomized controlled trial with an exercise group and a wait-list control group that could cross over to the exercise group at week 12.
Recruitment and retention rates were 31% and 91%, respectively. The adherence rate was 28%. The analyses did not suggest statistically significant or clinically important benefits in QOL, fatigue, or physical fitness between groups. There were no adverse events.
Successful recruitment with low adherence and limited effects on clinical outcomes including fatigue.
Further study is needed in this population including how to enhance exercise adherence.
Alexandrescu, D.T., Vaillant, J.G., & Dasanu, C.A. (2006). Effect of treatment with a colloidal oatmeal lotion on the acneform eruption induced by epidermal growth factor receptor and multiple tyrosine-kinase inhibitors. Clinical and Experimental Dermatology, 32, 71–74.
To evaluate the effectiveness of colloidal oatmeal lotion (Aveeno®), administered TID for at least seven days.
Multiple centers in Washington, DC, and New York, NY
This was an open-label study used to evaluate the rate and quality of response to colloidal oatmeal lotion.
Toxicity was graded as follows.
Treatment with colloidal oatmeal lotion appeared to be effective in controlling rash associated with EGFRIs and multiple TKIs. This treatment allowed for the continuation of antineoplastic therapy.
Albi-Feldzer, A., Mouret-Fourme, E.E., Hamouda, S., Motamed, C., Dubois, P.Y., Jouanneau, L., & Jayr, C. (2013). A double-blind randomized trial of wound and intercostal space infiltration with ropivacaine during breast cancer surgery: Effects on chronic postoperative pain. Anesthesiology, 118, 318–326.
To evaluate the short- and long-term effects of ropivacaine wound infiltration on pain after breast cancer surgery
Patients were randomized to receive, prior to surgery, either ropivacaine or normal saline placebo wound infusion. All patients received the same general anesthesia regimen of propofol and sufentanil. At the end of surgery, before skin suturing, the wound was completely infiltrated along the subcutanous and deep layers of the breast and axilla surgical incisions. Infiltration was also done in the second and third intercostal spaces. The ropivacaine group received 3 mg/kg of 0.375% ropivacaine. Pain was assessed every 30 minutes for two hours in the postanesthesia care unit and every six hours for the next 48 hours. Patients completed study questionnaires at baseline and at 3, 6, and 12 months after surgery.
Mutliple phases of care
Randomized double-blind placebo-controlled trial
Surgical wound infusion with ropivacaine resulted in significantly lower acute postoperative pain as measured up to 48 hours after breast cancer surgery. Wound infusion had no effect on longer-term postoperative pain.
Authors did not describe chronic levels of pain at follow-up time points.
Local wound infusion resulted in significantly lower acute postoperative pain after breast cancer surgery. This study adds to the body of evidence that demonstrates the effectiveness of this approach. Nurses can advocate for this approach to help ensure that surgical patients receive effective acute pain management.
Albers, J.W., Chaudhry, V., Cavaletti, G., & Donehower, R.C. (2014). Interventions for preventing neuropathy caused by cisplatin and related compounds. Cochrane Database of Systematic Reviews, 3, CD005228.
STUDY PURPOSE: To examine the efficacy of chemoprotective agents to prevent or limit neurotoxic side effects of cisplatin and related chemotherapy agents
TYPE OF STUDY: Meta-analysis and systematic review
PHASE OF CARE: Active antitumor treatment
There is insufficient high quality evidence to show that any agent is protective against platinum-induced neuropathy. There is some suggestion that amifostine, glutathione, and calcium and magnesium may have some effect.
There is insufficient evidence to show that any agent is truly effective in protecting against neurotoxic effects of platinum-based chemotherapy. There is a continued need for well designed research using appropriate objective as well as subjective measures of neuropathy.
Albers, J.W., Chaudhry, V., Cavaletti, G., & Donehower, R.C. (2011). Interventions for preventing neuropathy caused by cisplatin and related compounds. Cochrane Database of Systematic Reviews (Online), Feb. 16 (2), CD005228.
Examine the efficacy of purported chemoprotective agents to prevent or limit neurotoxicity of cisplatin and related agents
TYPE OF STUDY: Combined systematic review and meta-analysis
DATABASES USED: Cochrane Neuromuscular Disease Group Specialized Register, Cochrane Central Register of Controlled Clinical Trials, MEDLINE, EMBASE, LILACS, and CINAHL
KEYWORDS: Extensive list provided in article appendix
INCLUSION CRITERIA: Quasi-randomized or randomized clinical trials whose participants received cisplatin (or related compounds) chemotherapy with or without a potential chemoprotectant and were evaluated zero to six months after completing chemotherapy using quantitative sensory testing (primary) or other measures, including nerve conduction studies or neurologic impairment rating using validated scales (secondary)
TOTAL REFERENCES RETRIEVED: Sixteen randomized trials were evaluated in the initial 2006 review. In the 2010 update, 11 additional randomized trials not among the 2006 review were identified.
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Cochrane method of evaluation for risk of bias done by two authors and finalized by consensus
Cisplatin is considered to have neurotoxic effects, with patients developing sensory neuropathy. Symptoms of pain, numbness, and tingling are observed mostly in the extremities from a distal to proximal distribution. The neuropathy experienced by patients may recover partially or may become permanent. Neuroprotective agents such as acetylcysteine, acetyl-L carnitine, amifostine, calcium and magnesium, growth factors, glutathione, ORG 2766, oxcarbazepine, and vitamin E have been tested. The five newly added randomized controlled trials included three chemoprotective agents not previously described in the 2006 review.
From the data examined in this updated review, inconclusive evidence exists for recommending any neuroprotective agent tested to prevent or limit the neurotoxicity of platinum chemotherapy.
While 1,537 participants were included in the 2010 update, few trials were amenable to meta-analysis. Clinical trials of neuroprotective agents are plagued by issues of study design, including small sample size, unclear randomization and blinding procedures, and lack of quantitative measures, especially conventional QST or electrophysiologic evaluation.
Ala, S., Saeedi, M., Janbabai, G., Ganji, R., Azhdari, E., & Shiva, A. (2016). Efficacy of sucralfate mouth wash in prevention of 5-fluorouracil induced oral mucositis: A prospective, randomized, double-blind, controlled trial. Nutrition and Cancer, 68, 456–463.
To determine the efficacy of sucralfate mouthwash in the prevention of oral mucositis (OM) in patients receiving fluorouracil (5-FU) chemotherapy
Patients 18 years and older receiving chemotherapy containing 5-FU and calcium folinate were randomized into two groups through a computer-generated list of random numbers. One group received sucralfate suspension mouthwash and the other group received a placebo. Both groups received 10 ml of either sucralfate or placebo mouthwash every six hours for 10 days after the last dose of chemotherapy. Patients were instructed to rinse their mouth with the suspension for at least five minutes and spit it out 30 minutes after meals to ensure prolonged exposure of the mouthwash to the mucosal membranes.
A statistically significant difference in the severity of mucositis was shown between the sucrafate group and placebo group on both day 5 and day 10 (p = 0.005, p < 0.001), respectively. The severity of mucositis in the sucrafate group on day 5 and 10 was grade 0. The majority of patients in the placebo group had a mucositis severity grade 2 on day 5 and day 10. A statistically significant reduction in pain intensity was shown in the sucrafate group versus the placebo group on both day 5 and day 10 (p = 0.004, p = 0.001), respectively.
Sucralfate mouthwash may be more effective than placebo in the prophylaxis of 5-FU–induced OM. A correlation between both the reduction of pain intensity and mucositis severity was shown with the use of the sucralfate mouthwash suspension, further confirming the role of sucralfate in the prophylaxis of OM in patients receiving 5-FU chemotherapy.
Sucralfate mouthwash may be effective in reducing the severity and pain intensity of OM in patients receiving 5-FU.