Phase III Randomized Trial of Calendula Officinalis Compared With Trolamine for the Prevention of Acute Dermatitis During Irradiation for Breast Cancer

Abstract

Calendula is highly effective for the prevention of acute dermatitis of grade 2 or higher and should be proposed for patients undergoing postoperative irradiation for breast cancer.

RTOG criteria to evaluate acute skin reaction and its risk factors in patients with breast cancer submitted to radiotherapy

“…These data are comparable to those found in literature, in which studies show evolution to degree 3 from 10 to 15% and from 7 to 20% (9) . When the breast region and the degree of skin reaction are evaluated, 100% of degree 3 reactions were in the inframammary region.…”

Prophylaxis and Management of Acute Radiation-Induced Skin Reactions: A Systematic Review of the Literature

“…Twenty-one of the trials were open 3,16,19,20,24-26, 28,29,32-35,37-43,45 , three were single-blind 17,22,27 , and nine were double-blind 2,18,21,23,30,31,36,44,46 . Of the six management trials, three were rcts 49,50,52 , and three were nonrandomized clinical trials 47,48,51 .…”

“…Reasons for exclusion of patients from analysis included lack of compliance with the agent or dressing, withdrawal from the study, or failure to show up to clinic appointments. Skin reactions were often assessed by one evaluator, which was commonly a radiation oncologist, dermatologist, research nurse, research assistant, radiation therapist, principal investigator, or other medical professional 3,17,20,21,24,26,27,32,33,35,39,44,46,50 . A few studies incorporated an inter-rater reliability measure by having more than one evaluator assess the skin reactions 23,34,36,45,49,51 ; the remaining studies did not describe who assessed the radiated area or areas 2,16,19,25,28,30,31,38,[41][42][43]47,48 .…”

Dietary Supplement Use in Cancer Care: Help or Harm

“…Allergic reactions occurred in two chamomile-treated patients and one almond oil patient. A large phase III clinical trial tested the efficacy of a calendula or trolamine in preventing grade II or higher dermatitis in breast cancer patients during radiation [162]. Subjects (n ¼ 254) were randomized to apply either to a proprietary calendula homeopathic lotion or trolamine to the skin at least twice a day throughout the course of radiation.…”

“…Decreased dermatitis [162] Chamomile Decreases fatigue [184][185][186][187] Black cohosh extracts in breast cancer patients with menopausal symptoms Decreases vasomotor symptoms in some trials [189,191] Green or black tea in leukoplakia Improved abnormality [194,195] Green tea extract in high-grade intraepithelial neoplasia of the prostate without conventional therapy Decreased progression to frank prostate cancer [196] Pomegranate juice in prostate cancer patients with rising PSA after radiation or surgery…”