Apolone, G., Corli, O., Negri, E., Mangano, S., Montanari, M., Greco, M.T., . . . Zucco, F. (2009). Effects of transdermal buprenorphine on patients-reported outcomes in cancer patients: Results from the Cancer Pain Outcome Research (CPOR) Study Group. Clinical Journal of Pain, 25(8), 671–682.
To assess the effects of various analgesic options, particularly transdermal buprenorphine, on cancer-related pain
This study is a multicenter trial in which participants were patients with advanced solid tumors and persistent cancer-related pain that required analgesic treatment. For one month investigators collected descriptive data, including data from screening and weekly assessments and data related to medical history, examination findings, medications, analgesic consumption, pain assessment, satisfaction with pain treatment, and patient self-reports of quality of life. Data were collected up to the final visit, at week 12. This study did not describe specific pain interventions. Data relating to various subgroups were described and analyzed.
Nonrandomized open-label prospective, descriptive study
Patients using transdermal buprenorphine tend to show more pain reduction than patients who are taking other WHO level III analgesia. The majority of patients seem to tolerate transdermal buprenorphine well. Approximately 30% of patients were unresponsive to transdermal buprenorphine.
Transdermal buprenorphine may be a helpful alternative and adjunct in the management of cancer-related pain. Note that approximately one-third of patients in the study did not respond to this medication. Other studies have shown that absorption of transdermal medication varies among individuals. Findings point to the importance, in ensuring optimal pain management, of timely and consistent pain reassessment, particularly if switching from one approach to another or when adding medications to a regimen.
Aoyama, T., Nishikawa, K., Takiguchi, N., Tanabe, K., Imano, M., Fukushima, R., . . . Tsuburaya, A. (2014). Double-blind, placebo-controlled, randomized phase II study of TJ-14 (hangeshashinto) for gastric cancer chemotherapy-induced oral mucositis. Cancer Chemotherapy & Pharmacology, 73, 1047–1054.
To study the safety and efficacy of TJ-14 in preventing or treating chemotherapy-induced mucositis versus a placebo in patients with gastric cancer
Patients who identified a Common Terminology Criteria for Adverse Events (CTCAE version 4) grade 1 or greater mucositis were randomized on a one-to-one ratio and stratified according to age, chemotherapy regimen, institution, and previous treatment for oral mucositis. Participants received either TJ-14 or a placebo beginning with their next cycle of chemotherapy. The placebo was prepared to mimic the intervention. TJ-14 and the placebo were given three times per day. Patients were instructed to dissolve 2.5 g (total daily dose 7.5 g) of either TJ-14 or the placebo in 50 mL of regular drinking water and to rinse the oral cavity for 10 seconds. Treatment began on the first day of the protocol treatment, continued till the final day, and was administered as much as possible for one course of treatment. No other mouthwash prophylactic interventions for oral mucositis were allowed during the trial period. Assessments took place during the screening cycle from the beginning of the protocol treatment or the appearance of mucositis until all symptoms disappeared.
Randomized, double-blinded, controlled, phase II trial
In this study, 40% of patients in the intervention group and 41.3% of patients in the placebo group experienced ≥ grade 2 oral mucositis, and there was no difference between the groups (p = .588). In addition, there was no difference between the two groups concerning the duration of oral mucositis (p = .937).
This study did not demonstrate any beneficial effects of TJ-14 in reducing the incidence of chemotherapy-induced oral mucositis.
No prophylactic or treatment-related benefits of TH-14 were evident in this study regardless of the grade of chemotherapy-induced oral mucositis. Nurses should consider other interventions for the prevention and treatment of oral mucositis.
Antunes, H.S., Ferreira, E.M., de Matos, V.D., Pinheiro, C.T., & Ferreira, C.G. (2008). The impact of low power laser in the treatment of conditioning-induced oral mucositis: A report of 11 clinical cases and their review. Medicina Oral, Patología Oral y Cirugía Bucal, 13(3), 189–192.
Low-power laser therapy (LPLT) versus placebo
Only dentists knew the randomization.
Low level intensity laser: InGaAIP diode laser—660 nm, 46.7 mW
Predental care
Oral care: Extrasoft toothbrushes; dental paste with a peroxidase system after meals, and alcohol-free chlorhexidine solution until neutrophil recovery TID
Evaluations were performed daily by one dentist (not blinded) and three nurses (blinded).
Crossover allowed for control group patients who developed grade 4 oral mucositis.
The sample was comprised of 38 patients with HSCT.
Adults M =36.5/36.8
Women = 7/8
Men = 12/11
Autologous HSCT = 5/5
Allogenic HSCT = 14/14
Centro de Transplante de Medula Ossea
January 2004-May 2005
Randomized, placebo-controlled, quantity and prospective clinical trial
WHO scale
OMAS
VAS
All patients completed the study; none were lost to follow-up or excluded.
LPLT less intense oral mucositis
Grade 0 = 1, 63.2%, 12 of 19 versus 10.5%, 2 of 19 (p < 0.001)
6 LPLT, 31.5% WHO Grade 2
94.7% WHO 0–2
Control group was the opposite (data not provided) (p < 0.001).
Mucositis-free survival hazard ration grade 2, 3, and 4 was 0.41 (p = 0.002); the hazard ration grade for grade 3 and 4 was 0.07.
OMAS = 84.2% (16) patients receiving laser treatment stayed on a weighted average zone of 0–2.9 versus 26.3% (5) (p = 0.007).
Patients receiving laser treatment presented with small extension of ulcerous area (p = 0.003).
Control group showed mucositis earlier (D + 5) than laser group (D + 6) (p = 0.67, NS).
Longer duration 6 versus 9 (p = 0.13, NS)
Longer to heal (p = 0.15)
No differences in presence and intensity of pain
No differences in blood cultures
The level of agreement among evaluators was 81.7%.
Sample size
Implies difference when p value is not significant
Narrative frequently does not match p values.
Antunes, H.S., Herchenhorn, D., Small, I.A., Araújo, C.M., Viégas, C.M.P., Cabral, E., . . . & Ferreira, C.G. (2013). Phase III trial of low-level laser therapy to prevent oral mucositis in head and neck cancer patients treated with concurrent chemoradiation. Radiotherapy and Oncology, 109(2), 297–302.
To assess the efficacy of preventive low-laser therapy to reduce grade 3 and 4 oral mucositis (OM) in patients receiving chemoradiation
Both groups received cisplat 100 mg/m2 for three cycles every three weeks, radiation 70.2 Gy (1.8 Gy per day five times per week), and the same oral hygiene. The intervention group received low-level laser therapy five times per week before every fraction of radiation. The energy and energy density were the same for each patient. A dentist applied the laser tip to the mucosa of the lips, the right and left buccal mucosa, the left and right lateral tongue border, the buccal floor, and the ventral tongue. The placebo group had the laser tip touched to the same sites, but there was no laser light.
A significant decrease was seen in the rate of grades 3 and 4 OM in the treatment group. Relative risk ratio (6.4% with laser versus 40.5% control) 0.158 (CI 95%). The treatment group reported better physical, emotional, fatigue, and pain scores and had less pain, fewer problems swallowing, and less trouble with social eating.
Low-level laser light therapy is effective in reducing grades 3 and 4 OM in patients with squamous cell carcinoma of the head and neck undergoing concurrent chemotherapy and radiation.
Nurses who work in facilities with access to low-level laser light therapy should advocate for the use of it for their patients with head and neck cancer undergoing radiation and chemotherapy. There may be a role for nurses in learning to administer low-level laser light therapy.
Antoni, M.H., Lehman, J.M., Kilbourn, K.M., Boyers, A.E., Culver, J.L., Alferi, S.M., . . . Carver, C.S. (2001). Cognitive-behavioral stress management intervention decreases the prevalence of depression and enhances benefit finding among women under treatment for early-stage breast cancer. Health Psychology, 20, 20–32.
Participants were randomly assigned to the intervention or control group. The intervention one was a closed, structured group that met weekly for 10 two-hour sessions. It included didactic material, experiential exercises, and homework assignments (practicing relaxation exercises) and focused on learning to cope better. The control group participants received a condensed version of the intervention during a five- to six-hour seminar; it provided information but lacked the therapeutic group environment and support. Participants were assessed initially, post-treatment, at three months, and at nine months. The study was advertised by letters and posters, and participants phoned for eligibility screening.
The intervention group showed reduced prevalence of moderate depression per the CES-D. The intervention also influenced two measures of positive well-being—increasing reports of experiencing benefit from having had breast cancer and increasing general optimism about the future.
An implication here is that it is important to collect information on positive experiences as well as negative. Responding to adversity presents an opportunity to experience growth and positive change.
Although this is a well-designed RCT, several flaws exist.
Antonarakis, E.S., Evans, J.L., Heard, G.F., Noonan, L.M., Pizer, B.L., & Hain, R.D. (2004). Prophylaxis of acute chemotherapy‐induced nausea and vomiting in children with cancer: What is the evidence? Pediatric Blood and Cancer, 43, 651–658.
PHASE OF CARE: Active antitumor treatment
APPLICATIONS: Pediatrics
Based on published evidence, many pediatric patients may not be receiving appropriate antiemetic therapy. The patients who were most likely to not receive recommended antiemetic therapy were those receiving highly emetogenic chemotherapy, which put those patients at an increased risk for experiencing CINV.
This study took place in the United Kingdom, which may have different medication availability and prescription practices than other locations.
In the pediatric population, antiemetic prescription practices may not be in line with published evidence. Current best-practice sources should be consulted to ensure pediatric patients are adequately medicated to prevent CINV.
Antonadou, D., Pepelassi, M., Synodinou, M., Puglisi, M., & Throuvalas, N. (2002). Prophylactic use of amifostine to prevent radiochemotherapy-induced mucositis and xerostomia in head-and-neck cancer. International Journal of Radiation Oncology, Biology, Physics, 52, 739–747.
Patients in the study group received 300 mg/m2 amifostine 15–30 minutes before radiation therapy (RT) on days 1–5 of each week. Patients in both the study group and the control group received 90 mg/m2 carboplatin once per week before RT. Treating physicians and patients reported data.
The study was conducted between January 1997 and January 1998.
The Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/EORTC) 0–4 grading system was used.
Ansari, M., Porouhan, P., Mohammadianpanah, M., Omidvari, S., Mosalaei, A., Ahmadloo, N., . . . Hamedi, S. H. (2016). Efficacy of ginger in control of chemotherapy induced nausea and vomiting in breast cancer patients receiving doxorubicin-based chemotherapy. Asian Pacific Journal of Cancer Prevention, 17, 3877–3880.
To evaluate the efficacy of adding powdered ginger to prevent chemotherapy-induced nausea and vomiting (CINV) in women with breast cancer receiving moderately emetogenic chemotherapy
Women with breast cancer were randomized to receive either 500 mg ginger or placebo twice a day for three days, during the course of three cycles of chemotherapy.
PHASE OF CARE: Active antitumor treatment
Double-blind, randomized, longitudinal
Not described; only states that participants were asked to “record the episodes of vomiting and nausea severity”
No significant difference in nausea or vomiting existed when comparing the ginger group to the placebo group.
The results of this study do not indicate that powdered ginger capsules (1 g daily) are effective in reducing CINV in women with breast cancer receiving chemotherapy.
Measurement/methods not well described
Powdered ginger capsules may not offer CINV relief for patients receiving chemotherapy.
Ansari, M., Farzin, F., Mosalaei, A., Omidvari, S., Ahmadloo, N., & Mohammadianpanah, M. (2013). Efficacy of topical alpha ointment (containing natural henna) compared to topical hydrocortisone (1%) in the healing of radiation-induced dermatitis in patients with breast cancer: A randomized controlled clinical trial. Iranian Journal of Medical Sciences, 38, 293–300.
To compare the efficacy between topical alpha ointment, which contains natural henna, and topical 1% hydrocortisone cream in the healing of radiation-induced dermatitis in patients with breast cancer
Patients in both arms were instructed to wash the area of the treatment field daily. The intervention included topical alpha ointment, which contains natural henna (i.e., Lawsonia inermis Linn), applied twice a day in a thin layer over the chest wall field commencing the last day of treatment and continuing for three weeks. The active control included topical 1% hydrocortisone cream applied twice a day in a thin layer over the chest wall field commencing the last day of treatment and continuing for three weeks. The patient’s dermatitis area was examined independently by two physician raters each week. The patient’s reported skin burning, pain, pruritus, and amount of discharge were recorded during the weekly physician visit. The primary endpoint of the study was speed measured in cm/week of dermatitis healing (i.e., complete reepithelialization of moist desquamation).
Originally, 63 patients were assessed for eligibility, and three were ineligible. Of the remaining 60 patients, with 30 in each arm, none were lost to follow-up. There was no statistically significant difference in mean age, dermatitis area, dermatitis grade, and total radiation dose between members of the two arms. The mean area of grade 2 and 3 radiodermatitis was significantly less in the alpha ointment arm (51.64 ± 59.04 cm2) as compared to the hydrocortisone arm (74.77 ± 71.20 cm2, p = 0.007) during the second week but not at baseline, the first week, or the third week. There was no difference in patient-reported burning throughout the study. Alpha ointment significantly decreased patient-reported pain (p < 0.001), pruritus (p = 0.009), and the amount of discharge (p = 0.010) at three weeks as compared to hydrocortisone cream.
Alpha ointment significantly enhanced radiation dermatitis healing as compared to hydrocortisone cream. Alpha ointment also reduced patient-reported pain, pruritus, and the amount of discharge, but not skin burning.
Alpha ointment with an active ingredient of henna may be an effective treatment to manage grades 2 and 3 radiodermatitis. Additional studies are needed.