Prevention of acute radiation-induced Proctitis by Aloe vera: a prospective randomized, double-blind, placebo controlled clinical trial in Pelvic Cancer patients

Abstract

Background: Acute radiation-induced proctitis (ARP) is the most common side effect following radiotherapy for malignant pelvic disease. This study evaluated the efficacy of Aloe vera ointment in prevention of ARP. Methods: Forty-two patients receiving external-beam radiotherapy (RT) for pelvic malignancies were randomized to receive either Aloe vera 3% or placebo topical ointment during radiotherapy for 6 weeks. These patients were evaluated based on the severity (grade 0-4) of the following symptoms weekly: rectal bleeding, abdominal/rectal pain, diarrhea, or fecal urgency. RTOG acute toxicity criteria and psychosocial status of the patients were also recorded weekly. Lifestyle impact of the symptoms, and quantitative measurement of C-reactive protein (CRP), an indicator of systemic inflammation, were also measured. Results: The results of present study demonstrated a significant preventive effect for Aloe vera in occurrence of symptom index for diarrhea (p < 0.001), rectal bleeding (p < 0.001), and fecal urgency (p = 0.001). The median lifestyle score improved significantly with Aloe vera during RT (p < 0.001). Intervention patients had a significant lower burden of systemic inflammation as the values for quantitative CRP decreased significantly over 6 weeks of follow-up (p = 0.009). Conclusion: This study showed that Aloe vera topical ointment was effective in prevention of symptoms of ARP in patients undergoing RT for pelvic cancers.

Medical Plant of Aloe Vera in Desert Regions of Iran: Greenhouses, Economic Importance, Development, Extension, Processing and Marketing

“…Aloe Vera has been used for centuries for its health, beauty, medicinal and skin care properties (Sahebnasagh et al, 2020). At present, a number of prescribed drugs come from plants.…”

“…Although the mechanism of action by which Aloe Vera might facilitate healing is not clearly delineated, one hypothesis is that it exerts its effects as a result of antioxidant and immunomodulatory properties, and cyclooxygenase-2 suppression. One of active compounds in Aloe is salicylic acid, which can be converted into salicylate and thereby inhibits prostaglandin synthesis and the resulting inflammation (Sahebnasagh et al, 2020). Aloe Vera leaves contain anthraquinones, saccharides, vitamins, amino acids, minerals, enzymes, fatty acids, other emollient, healing, clotting, moisturizing, antiallergic, disinfectant, anti-inflammatory, astringent, choleretic, laxative, and other compounds.…”

“…Aloe Vera extract has been shown to be effective in this dermal condition, too. Aloe extracts has proven antioxidant activity which protects against ROS-induced membrane and cellular damage (Sahebnasagh et al, 2020).…”

“…Aloe Vera mouthwash has shown promised efficacy in prevention and alleviation of radiationinduced mucositits in head and neck cancers without marked side effects. In previous clinical studies, a significant number of patients with chronic radiation proctitis seemed to benefit from combination antioxidant therapy of Vitamin C and E with sustained improvement in their clinical symptoms for as long as 1 year (Sahebnasagh et al, 2020).…”

A Ten-year-long Update on Radiation Proctitis Among Prostate Cancer Patients Treated With Curative External Beam Radiotherapy

“…). Sahebnasagh et al(86) demonstrated that Aloe vera topical ointment could be effective in prevention of RP; this finding is particularly notable given the non-existent toxicity profile of this product. In a randomized controlled phase II trial conducted by Saadipoor et al(87), oral nanocurcumin was not superior to placebo in preventing or mitigating symptoms of proctitis in patients undergoing RT for prostate cancer, but this fact could be due to the lack of a sufficiently large sample size to identify a statistically significant difference (underpowered study).…”