Elliott, E. A., Wright, J. R., Swann, R. S., Nguyen-Tân, F., Takita, C., Bucci, M. K., . . . Radiation Therapy Oncology Group Trial 99-13. (2006). Phase III trial of an emulsion containing trolamine for the prevention of radiation dermatitis in patients with advanced squamous cell carcinoma of the head and neck: results of Radiation Therapy Oncology Group Trial 99-13. Journal of Clinical Oncology, 24, 2092–2097.
This phase 3 trial was designed to compare an emulsion containing trolamine against usual supportive care within each participating institution.
Patients were randomly assigned to one of three treatment arms: (a) prophylactic trolamine emulsion, (b) interventional trolamine emulsion, and (c) declared institutional preference.
In both trolamine arms, trolamine was applied at four-hour intervals. Patients were instructed to maintain at least four hours between trolamine and radiation therapy (RT).
Trolamine use was discontinued immediately if an allergic reaction occurred or if grade 3 dermatitis was reported in any area larger than 1.5 cm of confluent desquamation or bleeding in the treatment area.
Fifty-one institutions in various states in the United States
The study was a randomized, controlled trial.
The results demonstrate no advantage for the use of trolamine in reducing the incidence of grade 2 or higher radiodermatitis or improving patient-reported QOL.
Ell, K., Xie, B., Quon, B., Quinn, D.I., Dwight-Johnson, M., & Lee, P.J. (2008). Randomized controlled trial of collaborative care management of depression among low-income patients with cancer. Journal of Clinical Oncology, 26, 4488–4496.
To determine the effectiveness of Alleviating Depression Among Patients with Cancer (ADAPt-C) collaborative care management for major depression or dysthymia
ADAPt-C is collaborative care management developed for low-income and minority patients. The control group received enhanced usual care (EUC). Data collection occurred at baseline, 6 months, and 12 months. The intervention involved semistructured assessment and patient and family education, navigation assistance, behavioral therapy components in weekly sessions, and patient homework. After treatment initiation, patients received monthly telephone contact for up to 12 months, for maintenance and relapse prevention. Medication was used as clinically indicated for psychiatric symptoms. Overall management was based on guidelines, from the National Comprehensive Cancer Care Network, for treatment of depression in cancer patients.
Active treatment and transition
Prospective, randomized, controlled trial with simple blinding
ADAPt-C collaborative care may be a feasible and effective means of reducing symptoms of depression in some cancer patients.
ADAPt-C is a time- and personnel-intensive intervention that requires significant commitment on the part of the patient.
Elkins, G., Marcus, J., Stearns, V., Perfect, M., Rajab, M.H., Ruud, C., … Keith, T. (2008). Randomized trial of a hypnosis intervention for treatment of hot flashes among breast cancer survivors. Journal of Clinical Oncology, 26, 5022–5026.
Researchers compared a hypnosis intervention (five weekly sessions) or no treatment.
Sixty female breast cancer survivors with hot flashes were enrolled. Eligible patients had to have a history of primary breast cancer without evidence of detectable disease and 14 or more weekly hot flashes for at least one month.
Participants were randomly assigned to treatment with hypnosis or no treatment.
The instrument was the Hot Flash Related Daily Interference Scale.
Fifty-one randomly assigned women completed the study. By the end of the treatment period, hot flash scores (frequency and average severity) decreased 68% from baseline to end point in the hypnosis arm (p ≤ 001). Significant improvements in self-reported anxiety, depression, interference of hot flashes on daily activities, and sleep were observed for patients who received the hypnosis intervention (p ≤ .005) in comparison to the no treatment control group.
Study limitations included:
Elkins, G., Marcus, J., Stearns, V., & Rajab, M.H. (2007). Pilot evaluation of hypnosis for the treatment of hot flashes in breast cancer survivors. Psycho-Oncology, 16, 487–492.
The study looked at the effectiveness of hypnosis in treating hot flashes in breast cancer survivors.
Each participant received four weekly sessions of hypnosis using a standardized transcript and was instructed in self-hypnosis.
Sixteen breast cancer survivors were enrolled.
This was a pilot study.
Participants kept daily diaries of the frequency and severity of their hot flashes. They also completed baseline and post-treatment ratings of the degree to which hot flashes interfered with daily activities and QOL using the Hot Flash-Related Daily Interference Scale.
Results indicated a 59% decrease in total daily hot flashes and a 70% decrease in weekly hot flash scores from the baselines. Participants experienced a significant decrease in the degree to which hot flashes interfered with daily activities for all measures including work, social activities, leisure activities, sleep, mood, concentration, relations with others, sexuality, enjoyment of life, and overall QOL.
This study was limited by its small sample size and the limitations inherent in single group study design. All of the participants expressed interest in hypnosis, which may indicate some selection bias. Because no comparable control group was used, identifying the exact efficacy of hypnosis as a treatment for hot flashes is not possible.
Elkerm, Y., & Tawashi, R. (2014). Date palm pollen as a preventative intervention in radiation- and chemotherapy-induced oral mucositis: A pilot study. Integrative Cancer Therapies, 13, 468–472.
To determine the effectiveness of date palm pollen (DPP) in the prevention and treatment of oral mucositis in patients undergoing radiation and chemotherapy for head and neck cancer
Two grams of DPP in powder form were mixed in 125 mL of water by the subjects. Patients were instructed to swish and swallow nightly for 42 days starting the day before treatment. The Oral Mucositis Assessment Scale (OMAS) was completed at days 0, 15, and 29. The first 10 subjects were enrolled in the treatment arm and the next10 subjects were in the control arm.
Controlled trial; control group received facility standard of care
The mean OMAS score was lower in the DPP-treated group with statistically significant differences on day 15 (p < .05) and day 21 (p < .05). The mean oral pain intensity level was lower in the DPP group on day 15 (p < .05) and day 21 (p < .05). Only one patient in the DPP group required soft food compared to 80% in the control group. There was a significant difference in the mean impact on swallowing on day 15 (p < .05) and day 21 (p < .05).
There was a significant reduction in the severity and incidence of mucositis as indicated by the OMAS and the VAS pain scales.
Although the mechanism of DPP is not totally clear, nurses should recognize that there are many plant derivatives that may have positive effects on oral mucositis. Larger, randomized trials of these agents are needed.
Benitez-Rosario, M.A., Martin, A.S., & Feria, M. (2005). Oral transmucosal fentanyl citrate in the management of dyspnea crises in cancer patients. Journal of Pain and Symptom Management, 30(5), 395–397.
To evaluate the use of oral transmucosal fentanyl citrate (OTFC) as a rescue or breakthrough medication to relieve dyspnea
This study described four individual case reports. In case 1, the patient received 1,200 mcg of OTFC as breakthrough dose (BT) for dyspnea while on 400 mg/d IV morphine. In case 2, the patient received 800 mcg of OTFC as BT for dyspnea while on 90 mg of oral morphine every 24 hours. In case 3, 600 mcg of OTFC originally was prescribed for pain was reported to relieve dyspnea. In case 4, the patient was given 400 mcg OTFC while on 15 mg/d IV morphine.
The case reports were of four patients who were terminally ill with cancer (two women and two men). Three patients had lung cancer, and one had colon cancer. OTFC was chosen for its rapid effect and ease of administration.
Cases 1, 2, and 4 were conducted at an inpatient hospice unit, and case 3 was conducted at home.
Cases 1 , 2, and 4 used numeric rating scales (NRSs), and case 3 used percent improvement.
These reports showed that OTFC improved dyspnea in individual cases, was easy to administer, and provided rapid onset of relief and minor adverse effects. The specific doses were variable and chosen according to patients’ baseline opioid use.
Eleutherakis-Papaiakovou, E., Kostis, E., Migkou, M., Christoulas, D., Terpos, E., Gavriatopoulou, M., . . . Papadimitriou, C.A. (2010). Prophylactic antibiotics for the prevention of neutropenic fever in patients undergoing autologous stem-cell transplantation: results of a single institution, randomized phase 2 trial. American Journal of Hematology, 85, 863–867.
To demonstrate the use of prophylactic antibiotics to prevent fever in autologous stem cell transplantation recipients.
Researchers used antibiotics prophylactically (ciprofloxacin and vancomycin) to prevent ElE infections during the neutropenic stage of transplantation. Patients were randomly assigned to receive 500 mg of ciprofloxacin orally twice a day and 1000 mg of vancomycin intravenously (IV) daily or no prophylactic antibiotic use. Antibiotics were given on day 0 and continued until neutropenia resolution or the occurrence of a febrile event. Antibiotics were given to any patient who experienced a febrile event. All patients received lenogastrim three days after cyclophosphamide and until harvesting and also from posttransplant day 1 until the white blood cell (WBC) count was >10x103 µg/dL.
This was a randomized, controlled study.
Between cell reinfusion and bone marrow reconstitution, 71.3% of patients receiving prophylactic antibiotics developed neutropenic fever, compared with 91.2% of those receiving only supportive care (p < 0.001). Patients receiving the combination of ciprofloxacin and IV vancomycin had a significantly lower rate of bacteremias (5.6%) than those with no prophylaxis (35%) (p = 0.005). The cumulative hazard ratio (HR) of fever for randomized patients demonstrated a statistical benefit in favor of prophylactic antibiotics (HR = 2.43; 95% confidence interval [1.60, 3.49]; p < 0.001). There were no infection-related deaths in the sample. There were no differences between groups in duration of hospitalization. Median duration of treatment was six days. Patients were followed for one month in the study. Five patients developed severe skin rash attributed to antibiotics and discontinued treatment. There were no clear differences between groups in adverse effects, and no other effects were severe enough to warrant discontinuation of antibiotics.
This article showed that the prophylactic antibiotics oral ciprofloxacin and IV vancomycin help to prevent neutropenic fever after transplant but that their usage is not helpful in either decreasing the overall length of stay in the hospital or decreasing the risk of complication-related deaths.
Findings support the use of prophylactic antibiotic therapy for reducing the prevalence of febrile neutropenia in this group of patients.
Elad, S., Luboshitz-Shon, N., Cohen, T., Wainchwaig, E., Shapira, M. Y., Resnick, I. B., et al. (2011). A randomized controlled trial of visible-light therapy for the prevention of oral mucositis. Oral Oncology, 47(2), 125-130.
To assess the efficacy of a visible-light therapy device for the prevention of OM in HSCT patients.
All patients received preventive protocols that included prophylactic antivirals for those at risk for infection, cyclosporine as GVHD prophylaxis in allogeneic transplant patients, and standard topical antibacterial and antifungal prophylaxis with chlorhexidine, Nystatin, and saline rinses. Subjects were randomized to the study group (N = 10) who received broad band visible light (BBVLT) therapy starting on the first day of conditioning 5 times per week, continuing until at least day 21 if score was 0 on OMAS and WHO Scales. Subjects assigned to the placebo group received sham therapy using a similar device. Otherwise treatment was continued until day 28. Patients were evaluated daily, and oral mucosa was evaluated weekly by the research team.
The study was comprised of 19 patients, age 24.5 - 66 years.
Males (%): 53, Females (%): 47
Key Disease Characteristics: Leukemia, lymphoma, five patients listed as other (2 active Rx, 3 Placebo).
Other Key Sample Characteristics: Adult patients receiving myeloablative and non-myeloablative conditioning regimens with chemo + or - TBI and prophylaxis. Examined prior to treatment to confirm intact mucosal lining. Karnofsky score greater than 60.
Site: Single site
Setting Type: Not specified
Location: Hadassah University Medical Center - Department of Bone Marrow Transplantation
Phase of Care: Active treatment
Randomized, placebo controlled and double blinded
There was a statistically significant difference in both the frequency of patients with no mucositis and the severity of the mucositis based on the WHO and OMAS scales at visit three only (p = 0.02) . Other than that, there were no statistically significant differences in frequency or severity of mucositis between the two groups. There was no significant difference in narcotic consumption between the two groups. Satisfaction was highly rated in both groups.
There were significantly better mucositis scores and lower pain levels in the treatment group at one week post-HSCT. Treatment was well tolerated with no adverse events related to the study device. The conclusion is that the BB-VLT device is safe and effective in the prevention of oral mucositis in HCST patients.
Small sample <30
Costly treatment, though less so than lasers. Significant differences were seen at only one time point.
Needs further study, though device appears easy to use and safe. BBVLT therapy may be a less costly alternative to laser treatments, and the device used could be operated by patients themselves for self care. Larger studies in this area are warranted.
Einhorn, L., Rapoport, B., Navari, R., Herrstedt, J., Brames, M., Einhorn, L.H., . . . Brames, M.J. (2017). 2016 updated MASCC/ESMO consensus recommendations: Prevention of nausea and vomiting following multiple-day chemotherapy, high-dose chemotherapy, and breakthrough nausea and vomiting. Supportive Care in Cancer, 25, 303–308.
RESOURCE TYPE: Consensus-based guideline
PROCESS OF DEVELOPMENT: A literature search for papers published between January 1, 2009, and January 6, 2015, related to high-dose chemotherapy, multiple-day chemotherapy regimens, and breakthrough nausea and vomiting
DATABASES USED: PubMed
INCLUSION CRITERIA: Clinical trials, systematic reviews, stem cell transplantations (SCTs), patients with germ cell tumors
EXCLUSION CRITERIA: Other studies
PHASE OF CARE: Active antitumor treatment
Few studies related to the prevention of acute and delayed CINV in patients receiving high-dose and multiple-day chemotherapy regimens and for breakthrough nausea and vomiting. Little evidence related to the control of nausea exists.
Aprepitant should be added to two-drug antiemetic regimens in patients receiving high-dose and multiple-day cisplatin regimens to prevent acute and delayed CINV. Olanzapine is recommended for breakthrough CINV.
Einhorn, L., H., Grunberg, S., M., Rapoport, B., Rittenberg, C., & Feyer, P. (2011). Antiemetic therapy for multiple-day chemotherapy and additional topics consisting of rescue antiemetics and high-dose chemotherapy with stem cell transplant: Review and consensus statement. Supportive Care in Cancer, 19, S1-S4.
To evaluate topics related to nausea and vomiting, specifically antiemetic therapy in high-dose chemotherapy with stem cell transplant and the use of rescue antiemetic for refractory emesis, with the intention of developing a consensus statement
Recommendations were rated using the Multinational Association of Supportive Care in Cancer (MASCC) and European Society for Medical Oncology (ESMO) levels of confidence for evidence strength rating.
Patients were in active treatment.
Patients receiving multiple-day cisplatin should receive a 5-HT3 receptor antagonist plus dexamethasone for acute nausea and vomiting and dexamethasone for delayed nausea and vomiting. Because emesis in progress is difficult to control, include maximally effective antiemetics in first-line prophylactic antiemetic regimens so that rescue therapy will not be necessary. No clear evidence was provided on the most effective management of breakthrough or refractory CINV, and it is recommended that maximal prophylactic antiemetics are the best current approach.
The authors concluded that control of nausea and vomiting with high-dose chemotherapy remains a problem and more evidence is needed to aid researchers in making guideline decisions as to how to best manage CINV using modern antiemetics. Limited evidence is available for management of breakthrough and refractory CINV.