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.
Maccio, A., Madeddu, C., Gramignano, G., Mulas, C., Floris, C., Sanna, E., . . . Mantovani, G. (2012). A randomized phase III clinical trial of a combined treatment for cachexia in patients with gynecological cancers: Evaluating the impact on metabolic and inflammatory profiles and quality of life. Gynecologic Oncology, 124, 417–425.
To compare the efficacy and safety of (arm 1) combined treatment with L-carnitine (4 g/day) plus celecoxib (300 mg/day) plus antioxidants (lipoic acid 600 mg/day, carbocysteine 2.7 g/day) plus megestrol acetate (MA) 320 mg/day versus (arm 2) MA 320 mg/day alone (considered standard of care) for the treatment of advanced neoplastic disease-associated symptoms in gynecologic patients with progressive or recurrent disease previously treated with one or more lines of chemotherapy
Primary endpoints included increase in lean body mass (LBM), decrease in resting energy expenditure (REE), decrease in fatigue, and an improvement in global quality of life (QOL). Secondary endpoints included appetite, grip strength, Glasgow Prognostic Score (GPS), Eastern Cooperative Oncology Group (ECOG) performance score, and serum markers of inflammation and oxidative stress: C-reactive protein (CRP), interleukin 6 (IL-6), tumor necrosis factor (TNF), leptin, reactive oxygen species (ROS), glutathione peroxidase (GPx), and superoxide dismutase (SOD).
Baseline anthropometric measures, physical examination, vital signs, tumor site, stage, chemotherapy regimen, weight loss in previous three to six months, performance status, Glasgow Prognostic Score, and QOL were assessed. After baseline assessment, randomization was completed by a biostatistician to arm 1 or arm 2. Treatment duration was planned for four months. All patients received 150 UI/kg of low molecular weight heparin subcutaneously for the treatment duration. Endpoints were assessed at baseline (before treatment) and at 4, 8, and 16 weeks, although all analysis was presented as a comparison between baseline and 16 weeks. Safety was monitored with weekly evaluations of adverse events and toxicity. All patients also received psychosocial counseling.
This multisite study was conducted in an inpatient setting in Italy.
This was an open-label, randomized, controlled, prospective study.
Groups were similar in patient characteristics. At 16 weeks, LBM increased significantly (p = 0.032) in arm 1 with a mean difference of +4.65 kg compared to arm 2. REE changes were decreased significantly in arm 1 (p = 0.046) compared to arm 2. Arm 1 had significant decreases in fatigue symptoms (p = 0.049) and a higher mean QOL score (p = 0.042) compared to arm 2. Arm 1 gained a significant amount of weight with a mean increase of 0.5 kg per week over 16 weeks (p = 0.002). REE and fatigue decreased in arm 1 significantly at 16 weeks but not in arm 2. Both arms had significantly increased appetite (p < 0.05) and decreased ECOG scores. There was no difference between groups in appetite. Serum markers for inflammation and oxidative stress decreased significantly in arm 1 at 16 weeks. No significant arm 2 findings resulted. Leptin increased significantly in arm 1 and moderately but nonsignificantly in arm 2. Two patients had grade 3 diarrhea in arm 1.
The multimodal arm (arm 1) had improved physical, inflammatory, oxidative stress markers and QOL compared to MA alone, but did not appear to make a difference in appetite.
Study findings support multimodal approaches, including psychosocial support, for symptom management. More work should include patient-reported outcomes, toxicity, and safety of the intervention.
Annino, L., Chierichini, A., Anaclerico, B., Finolezzi, E., Norata, M., Cortese, S., . . . Girmenia, C. (2013). Prospective phase II single-center study of the safety of a single very high dose of liposomal amphotericin B for antifungal prophylaxis in patients with acute myeloid leukemia. Antimicrobial Agents and Chemotherapy, 57, 2596–2602.
To evaluate the feasibility and tolerability of prophylactic administration of a single, very high dose of liposomal amphotericin B (L-AmB) in adult patients newly diagnosed with acute myeloid leukemia (AML) and undergoing induction chemotherapy
The study was a pilot, phase II, single-center trial. The L-AmB was used to evaluate its efficacy and the level of toxicity. The study enrolled patients with AML undergoing first remission induction chemotherapy from January 2004–January 2011.
Overall, 18 of the 48 (37.5 %) patients experienced at least one adverse effect (all CTC grade) after the first or second L-AmB, and only six of them (12.5%) reported CTC grade 3 adverse events related to L-AmB administration.
The study demonstrates the feasibility and safety of a single, very high dose of L-AmB as antifungal prophylaxis in patients with AML undergoing induction chemotherapy.
This study basically determines the use of L-AmB to be used safely in patients with AML undergoing induction chemotherapy and does not have enough specification related to nursing.
Anghelescu, D.L., Faughnan, L.G., Hankins, G.M., Ward, D.A., & Oakes, L.L. (2010). Methadone use in children and young adults at a cancer center: A retrospective study. Journal of Opioid Management, 7, 353–361.
To augment the literature on methadone applications in pediatric oncology
This was a retrospective review of all patients treated with methadone at St. Jude Children’s Research Hospital over a five-year period (October 2001–September 2006).
Methadone dosing data were available for 37 patients. Four patient records lacked baseline doses because methadone was initiated at another institution. Starting doses ranged from 0.06–3.8 mg/kg/d. The highest methadone dose was 9.4mg/kg/d. More than one-third of the patients (34.1%) had no documented adverse effects. The most common adverse effect was sedation (24.4%). No respiratory depression or pruritus were documented. Pain reduction was reported by comparing the maximum pain score on the day that methadone was discontinued to the maximum pain score on the day that methadone was initiated. Fourteen of the 41 patients had documented pain scores for both time points. Nine patients (64.3%) showed reduction of the pain score, and seven (50%) had complete resolution of pain.
Methadone was effective for pediatric patients with neuropathic pain or nociceptive pain unresponsive to other opioids, and it effectively prevented opioid withdrawal.
Prospective studies are needed to evaluate specific methadone regimens for each of the clinical entities described and to determine opioid conversion scales to and from methadone in the pediatric population.