A Phase III Study on the Efficacy of Topical Aloe Vera Gel on Irradiated Breast Tissue

Abstract

The aim of the study was to see if topical aloe vera gel would be beneficial in reducing the identified skin side-effects of radiation therapy, including erythema, pain, itching, dry desquamation, and moist desquamation, when compared with aqueous cream. The secondary aim was to assess the effect of other factors known to predict severity of radiation skin reaction, ie, breast size, smoking habit, and one or more drainages of lymphocele after surgery, on other skin side effects. A Phase III study was conducted involving 225 patients with breast cancer after lumpectomy or partial mastectomy, who required a course of radiation therapy using tangential fields. Patients were randomized to either topical aloe vera gel or topical aqueous cream to be applied 3 times per day throughout and for 2 weeks after completion of radiation treatment. Weekly skin assessments were performed by nursing staff. Aqueous cream was significantly better than aloe vera gel in reducing dry desquamation and pain related to treatment. Subjects with D cup or larger size breasts experienced significantly more erythema, regardless of treatment arm. For subjects who had undergone lymphocele drainage, the aloe vera group experienced significantly more pain than the aqueous cream group. Within the aqueous cream arm, smokers were significantly more likely to experience itching within the treatment field than were nonsmokers. Within the aloe vera arm, subjects who had undergone one or more lymphocele drainages after surgery were significantly more likely to experience erythema and itching within the treatment field than those who did not have drainage. In this study, aloe vera gel did not significantly reduce radiation-induced skin side effects. Aqueous cream was useful in reducing dry desquamation and pain related to radiation therapy.

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 .…”

“…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 .…”

“…The second most common tool in use was the U.S. National Cancer Institute's Common Toxicity Criteria (nci ctc), which is similar to the rtog and was used in nine studies 2,3,26,28,30,[37][38][39]46 . The remaining studies used a study-designed tool closely modeled after either the rtog or nci tool, with slight variations [18][19][20]23,31,43,49 .…”

“…The evidence for the use of nonsteroidal topical agents is conflicting: some trials were positive for nonsteroidal agents 30,33,35,37 ; others showed no statistical difference 34,36,38 . The evidence did not support the use of Aloe vera 22,23 or sucralfate cream 31,32 . There was some evidence to suggest that led treatment, pentoxifylline, silver-leaf dressings, washing with soap and water, and zinc supplements help to prevent radiation-induced skin reactions 3,17,[43][44][45] .…”

“…At a cumulative dose of more than 2700 cGy, a protective effect of adding Aloe vera to mild soap was noted, although the difference was nonsignificant. In a large double-blind study by Heggie et al 23 , Aloe vera was compared with an aqueous cream. The aqueous cream was found to be significantly better at reducing dry desquamation and pain secondary to treatment.…”