Cullum, J. L., Wojciechowski, A. E., Pelletier, G., & Simpson, J. S. (2004). Bupropion sustained release treatment reduces fatigue in cancer patients. Canadian Journal of Psychiatry, 49, 139–144.
Bupropion sustained release was initiated at 100 or 150 mg daily, and the dose was adjusted according to the patient’s response. The final bupropion dose ranged from 100 to 300 mg daily. The modal bupropion dose was 150 mg, and patients were treated and observed for as long as two years.
The study was a single-arm, open-label, case series.
Fatigue was evaluated on the Clinical Global Improvement (CGI) Scale by a clinician not directly involved in the trial.
Cost is incurred to acquire the drug.
Cullen, M.H., Billingham, L.J., Gaunt, C.H., & Steven, N.M. (2007). Rational selection of patients for antibacterial prophylaxis after chemotherapy. Journal of Clinical Oncology, 25, 4821–4828.
Adult patients with cancer receiving cyclic chemotherapy for solid tumors or lymphoma who were at risk for temporary, severe neutropenia (absolute neutrophil count [ANC] < 500/mm³) were treated with oral levofloxacin 500 mg or matching placebo daily for seven days during the expected neutropenic period. Treatment began on day 5 for regimens associated with early onset of neutropenia (e.g., docetaxel), day 8 for 14-day and 21-day cycles, and day 15 for 28-day cycles.
Patients were on study for a mean of 4.4 cycles of chemotherapy, with 45% of patients completing six cycles.
784 patients were randomly assigned to the placebo arm and received 3,459 cycles of chemotherapy (mean = 4.4 cycles per patient).
Random assignment of patients in the SIGNIFICANT trial was stratified by age (younger than age 40, 40–59, and 60 years of age and older) and cancer type (breast, testicular, small cell lung, Hodgkin disease, non-Hodgkin lymphoma [NHL], and others).
1,565 adults starting chemotherapy for solid tumors or lymphomas; eligible regimens were known to be associated with a risk of neutropenia (ANC < 500/mm³), but were not routinely given with granulocyte–colony-stimulating factor (G-CSF) support. Many different types of cancer were included.
60 oncology centers in the United Kingdom.
The study was a prospective, multicenter, randomized, double-blind, placebo-controlled trial with secondary univariate and multivariate analysis.
119 of 784 (15.2%) control group participants had at least one FE during chemotherapy.
Treatment benefit of quinolone prophylaxis was present across all cycles.
As reported in a 2005 article by the authors, the per-patient FE rate was 10.8% (84 of 781) for patients receiving levofloxacin compared with 15.2% for patients receiving placebo (119 of 784), giving a statistically significant reduction in the risk of FE (odds ratio = 0.67; 95% confidence interval [0.5, 0.91]; p =0.009).
For the first cycle only, the per-patient FE rate was 3.5% in patients receiving levofloxacin compared with 7.9% in controls (odds ratio = 0.42; 95% confidence interval [0.26, 0.66]; p =0.0001), whereas for non–first cycles, the per-patient FE rate was 7.8% (61 of 781) and 9.8% (77 of 784), respectively (odds ratio = 0.78; 95% confidence interval [0.55, 1.11]; p = 0.16).
Per-cycle FE rates in cycle 2 and cycles 2–6 indicate that prophylactic benefit is gained in the small number of patients who experience an FE in cycle 1, but not in the much larger group of patients who do not experience an FE in cycle 1.
The data suggest that the benefit of antibiotics is greatest in those who experience an FE in cycle 1 because they are at higher risk of developing an FE in subsequent cycles compared with patients who do not develop an FE in cycle 1.
Cui, Z., Xin, M., Yin, H., Zhang, J., & Han, F. (2015). Topical use of olive oil preparation to prevent radiodermatitis: Results of a prospective study in nasopharyngeal carcinoma patients. International Journal of Clinical and Experimental Medicine, 8, 11000–11006. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4565279/
To evaluate the effect of olive oil on radiodermatitis
Patients were randomly assigned to the olive oil group or the control group. Patients treated with olive oil used it three times daily beginning on the first day of radiation therapy (RT) and continued for two weeks after completion of RT. The control group used water in place of the olive oil. Both groups were instructed to gently wash with water alone or mild soap and water. Side effects were recorded by a dermatologist and radiologist who were blinded to the study group assignment.
PHASE OF CARE: Active antitumor treatment
Single-blind, randomized, controlled trial
Grade I and II skin reactions occurred in 93.6% of those using olive oil and 72.3% of those using water. Grade III reactions were seen in 6.4% of those in the experimental group and 27.7% of those in the control group (p < 0.01). Symptoms from VAS scores were also lower in the experimental group (p < 0.01). No patients developed grade IV skin toxicity.
Olive oil appeared to provide some protection against the development of severe radiodermatitis compared to cleansing and water alone.
Prophylactic use of topical olive oil may provide protection from the development of more severe radiodermatitis. Results of this study provide promising results. Further research to confirm these findings would be beneficial.
Cuesta-Vargas, A.I., Buchan, J., & Arroyo-Morales, M. (2014). A multimodal physiotherapy programme plus deep water running for improving cancer-related fatigue and quality of life in breast cancer survivors. European Journal of Cancer Care, 23, 15–21.
To assess feasibility and effectiveness of aquatic-based exercise in the form of deep water running as part of a multimodal physiotherapy program for breast cancer survivors in an effort to decrease cancer-related fatigue
Eight week program of one hour sessions, three times per week, of multimodal physiotherapy program combined with deep water running delivered by physiotherapists in groups of 8–10 participants. Each session included 30 minutes of land-based exercise, followed by 20 minutes of deep water running.
Statistically significant differences in fatigue were found between groups after eight weeks, with the intervention group reporting greater improvement in behavioral severity, affective/meaning, and sensory fatigue.
Demonstrated positive effects of exercise on cancer-related fatigue. Supports prior studies that demonstrated greater improvement combining educational and exercise programs
This is a difficult program to replicate, but it appears that it is likely to be effective in reducing cancer-related fatigue.
Cubero, D.I., & del Giglio, A. (2010). Early switching from morphine to methadone is not improved by acetaminophen in the analgesia of oncologic patients: A prospective, randomized, double-blind, placebo-controlled study. Supportive Care in Cancer, 18, 235–242.
To evaluate the efficacy of methadone as a substitute for morphine, and to investigate whether the addition of acetaminophen improves pain control in switching to methadone
Patients using morphine for oncologic pain who were on a stable dose for at least one week were recruited. Patients were rapidly switched to oral methadone without a transition period and randomized to receive acetaminophen or placebo with methadone for seven days. The daily morphine dose was converted to methadone in ratios according to the total daily morphine dose. In case of additional pain, patients were instructed to use extra methadone no more than every two hours using a dose equal to 25% of the total daily dose. Use of coanalgesics such as anti-inflammatory drugs, antidepressants, and neuroleptics was allowed. Pain intensity was evaluated daily and recorded by patients in a diary along with all analgesic medications used. Patients were followed for seven days.
The study design was double-blind, randomized, placebo-controlled for use of acetaminophen, and open label for switch to methadone.
Of the original study sample, 16% ended participation early due to treatment failure with intense pain, somnolence, or vomiting. Most patients who completed the study had a significant improvement in pain by the faces (p = 0.05) and numeric (p = 0.03) rating scales. There were no differences between patients who did and did not receive acetaminophen.
Study findings show that most patients can be switched from morphine to methadone with no transition period, with some improvement in side effects of constipation and xerostomia and adequate pain control. The addition of acetaminophen in this process was of no benefit.
This study shows that patients can be rapidly switched from morphine to methadone; however, this approach failed in 16% of patients. Methadone may be associated with less constipation and dry mouth, and may be a good pain control option for patients with these problems. Acetaminophen did not improve pain control with this switching process.
Cruz, F.M., de Iracema Gomes Cubero, D., Taranto, P., Lerner, T., Lera, A. T., da Costa Miranda, M., … del Giglio, A. (2012). Gabapentin for the prevention of chemotherapy-induced nausea and vomiting: A pilot study. Supportive Care in Cancer, 20, 601–606.
To evaluate the efficacy and safety of gabapentin for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) during the first cycle of moderately or highly emetogenic chemotherapy
Chemotherapy naïve patients with cancer who were scheduled to begin moderately or highly emetogenic chemotherapy were randomized to either receive 300 mg gabapentin or a placebo, in addition to a standard regimen of antiemetic prophylaxis (8 mg IV ondansetron, 10 mg IV dexamethasone, and 50 mg IV ranitidine before chemotherapy on day 1 and 4 mg oral dexamethasone twice a day on days 2 and 3).
Patients received either the gabapentin or the placebo five and four days before chemotherapy, once per day; three and two days before chemotherapy, twice per day; and one day before through five days after chemotherapy, three times per day. After chemotherapy was administered until the morning of day 5, patients kept diaries to record episodes of emesis or retching and severity of nausea over the previous 24 hours.
The primary outcome of this study was an evaluation of the number of patients reporting a complete response (CR), defined as the absence of nausea and vomiting and no use of rescue medications, during three timeframes.
The study was conducted at a single site at a large medical institution in Brazil.
All patients were in active treatment.
This was a randomized, double-blind, placebo-controlled trial.
Gabapentin may be a low-cost, nausea prophylaxis medication that can be used as an alternative to more expensive antiemetic medications. Although the authors described gabapentin as a low-risk medication, recent reports have linked gabapentin to increased rates of depression and suicide. It also has been commonly associated with the side-effects of drowsiness and dizziness.
For patients who are uninsured or underinsured and those living in developing countries where obtaining high-cost medications may be difficult, gabapentin may prove useful as a less-expensive alternative antiemetic prophylactic medication. Research should attempt to compare less expensive alternatives with current best practices.
Cruz, L.B., Ribeiro, A.S., Rech, A., Rosa, L.G., Castro, C.G., & Brunetto, A.L. (2007). Influence of low-energy laser in the prevention of oral mucositis in children with cancer receiving chemotherapy. Pediatric Blood and Cancer, 48(4), 435–440.
780 nm 60 mW 4 J/cm2 was applied uniformly to five areas of the oral cavity for five consecutive days from initiation of chemotherapy.
The sample was pediatric patients (some with HSCT) receiving a variety of chemotherapies.
Laser group: n = 29
Control group: n = 31
The study ran from May 2003-February 2005.
RCT was the study design.
CTC-NCI
Nutritional Status Assessment
Day 8,15
Day 8 results: 13 patients in the laser group and 7 patients in the control group with mucositis; median grade of mucositis was 2 for the laser group and 1 for the control group (p = 0.234)
Day 15 results: 13 patients in the laser group and 11 patients in the control group with mucositis; median grade of mucositis was 1 in both groups; prevalence and severity were similar (p = 0.208)
Almost identical prevalence of mucositis and other findings; no evidence to support laser for prevention
Rigorous oral care may have masked results.
Optimal timing of laser treatment is unknown.
Small sample
Cruciani, M., Malena, M., Bosco, O., Nardi, S., Serpelloni, G., & Mengoli, C. (2003). Reappraisal with meta-analysis of the addition of gram-positive prophylaxis to fluoroquinolone in neutropenic patients. Journal of Clinical Oncology, 21, 4127–4137.
To compare prophylaxis with a fluoroquinolone (ciprofloxacin, ofloxacin, perfloxacin, or norfloxacin) in combination with an antibiotic against gram-positive bacteria (penicillins, macrolide, rifampin, or vancomycin) compared to fluoroquinolone alone in neutropenic patients with cancer
DATABASES USED: MEDLINE, CANCERLIT, Database of Abstracts of Reviews of Effects, and Cochrane Library (1984–2002); the bibliographies of retrieved studies also were reviewed.
The addition of gram-positive prophylaxis to fluoroquinolones reduced
No difference was found between gram-positive prophylaxis and a fluoroquinolone compared with a fluoroquinolone alone with regard to
However, adding gram-positive prophylaxis significantly increased the occurrence of side effects, primarily gastrointestinal intolerance and liver function test abnormalities seen with rifampin and roxithromycin.
The authors concluded that the evidence does not support routine use of gram-positive coverage in combination with a fluoroquinolone for antibacterial prophylaxis in neutropenic patients with cancer.
Cruciani, M., Rampazzo, R., Malena, M., Lazzarini, L., Todeschini, G., Messori, A., & Concia, E. (1996). Prophylaxis with fluoroquinolones for bacterial infections in neutropenic patients: A meta-analysis. Clinical Infectious Diseases, 23, 795–805.
DATABASES USED: MEDLINE was searched for literature published from January 1984–October 1994. Current Contents also was used, as were the bibliographies from MEDLINE articles.
KEYWORDS: Key words used in the search were neutropenia/agranulocytosis and bacterial infections.
INCLUSION CRITERIA: Eligible studies were randomized, controlled trials with fluoroquinolones alone or in combination with gram-positive prophylaxis in granulocytopenic patients receiving chemotherapy for cancer.
Prophylaxis with fluoroquinolones alone was shown to significantly reduce the frequency of gram-negative bacteremia. No significant difference was found in terms of gram-positive bacteremia or infection-related mortality. Fluoroquinolone with gram-positive prophylaxis significantly reduced the frequency of gram-positive bacteremia. Fever-related morbidity and infection-related mortality were not affected. Of note, the majority of the studies (four of six) used fluoroquinolone alone in the control group.
Cruciani, R. A., Dvorkin, E., Homel, P., Malamud, S., Culliney, B., Lapin, J., . . . Esteban-Cruciani, N. (2006). Safety, tolerability and symptom outcomes associated with L-carnitine supplementation in patients with cancer, fatigue, and carnitine deficiency: a phase I/II study. Journal of Pain and Symptom Management, 32, 551–559.
Carnitine deficiency is among the many metabolic disturbances that may contribute to fatigue in patients with cancer. Administration of exogenous L-carnitine may hold promise as a treatment for this symptom. Carnitine was prepared by the institutional pharmacy at a concentration of 1 g/mL. The drug was administered in two daily doses for seven days. After the intervention period, patients were allowed to continue L-carnitine supplementation if desired. Patient outcomes were evaluated at baseline and on day seven.
Beth Israel Medical Center Continuum Hospice Care, Jacob Perlow Hospice, or the Cancer Center
Patients were undergoing the active treatment phase of care.
The study was an open-label, phase I/II clinical trial.
Brief Fatigue Inventory (BFI)
Patients who received the L-carnitine intervention experienced a significant decline in fatigue (p < 0.001) as BFI scores decreased from baseline (66.1 [standard deviation (SD) = 12]) to one week after treatment to (39.7 [SD = 26]).