L-Carnitine to Reduce Chemoradiotherapy-Induced Toxicity in Head and Neck Cancer: A Randomized Study.

Abstract

BACKGROUND: Treatment related toxicities for management of cancer lead to significant deterioration in the quality of life, increased morbidity, hospital admissions, and increased treatment interruptions. We carried out this study, to reduce treatment related toxicities without compromising treatment efficacy. OBJECTIVES: Evaluate L-carnitine in reducing toxicities in HNSCC patients undergoing concurrent chemoradiation. METHODOLOGY: Study conducted in the Department of Radiotherapy tertiary care center in Northern India from August 2018 to 2020. All patients were randomized into the study arm and control arm; the study arm received oral L-carnitine 500 mg thrice daily, with symptomatic treatment for chemoradiotherapy-induced toxicity. The control arm received only symptomatic treatment for chemoradiation-induced toxicities. Toxicity assessment was done biweekly during treatment using RTOG (Radiation Therapy Oncology Group) criteria for toxicity assessment. Nutritional assessment was done by comparing hemoglobin, albumin, and weight loss during treatment. Fatigue was assessed using the Brief Fatigue Inventory (BFI) and the quality of life was assessed using the EORTC-QLQ-C30 questionnaire. Response evaluation for the primary tumor and neck nodes was done using RECIST 1.1. RESULTS: Significant decrease in severity and delay in onset of dermatitis, mucositis, laryngeal reactions, and dysphagia were observed; however, no such benefit was seen in xerostomia. Treatment response was comparable in both arms. Mean post-treatment BFI in the test arm versus control arm was 37.22 and 52.24 (p-value 0.042), respectively. 28.75% of patients in the control arm and none in the study arm had albumin levels < 3.4 g/dL. Median weight loss in the test arm was 5.2% and in the control arm was 7.4%. Hospital admission was significantly less in the test arm. CONCLUSION: L-carnitine can be given to HNSCC patients receiving concurrent chemoradiation to lessen treatment related toxicity, but larger, multicentric randomized trials required to substantiate this conclusion.