Abstract CT122: RCT of an herbal mouthrinse for radiotherapy induced oral mucositis in cancer patients

Objectives: Primary aim of the ongoing study (NCT01898091) is to determine whether a mouthrinse containing extract of neem leaf (Azadirachta indica A. Juss.), a tropical evergreen tree with anti-inflammatory and anti-microbial medicinal properties, will lessen the severity of oral mucositis (OM) in patients undergoing radiation therapy (RT) to the head and neck. Secondary aims are to assess the effects of the neem mouthrinse on the microbial environment of the oral cavity and on quality of life.Methods: Design is a double-blind, controlled, randomized, parallel-group Phase II clinical trial at a single NCI designated center. Block-randomization was used for patient assignment, stratified by tobacco use. Eligibles were adults with histologically confirmed head and neck cancer (HNC) whose treatment includes RT for 7 weeks. HNC includes malignancy of the oral cavity, oro-pharynx and larynx (ICD-9 codes 140 - 149, 161; ICD-O morphology code of 2 or 3). Exclusion criteria include prior HNC radiotherapy, baseline mouth and throat soreness (MTS) score of >3, ECOG performance status >2, allergy or inability to use mouthrinse, and language barrier. Evaluable participants receive > 40 Gy RT and participate to week 6 RT. Study duration is 12 weeks with visits at baseline, weekly during RT, 3 telephone visits post RT, and one-month follow-up visit. Data were collected using the Oral Mucositis Daily Questionnaire, Functional Assessment of Cancer Therapy-Head and Neck, and Symptom Distress...

Source: Cancer Research - August 2, 2015 Category: Cancer & Oncology Authors: Reed, S. G., Cunningham, J. E., Garrett-Mayer, E., Mulligan, J. L., Fields, L. D., Boyle, L. R., Daanen, S. P., Keller, J. H., Roach, C. L., Pasquini, W. C., Lawrence, L., Harmon, H., Garrett, A. R., Wargovich, M. J., Sharma, A. K. Tags: Clinical Trials Source Type: research