Management of Chemotherapy and radiotherapy induced Oral mucositis with add on homoeopathy to standard care versus the standard care in patients with head and neck cancer - A Randomized Controlled Clinical Trial

Oral mucositis is a common, debilitating complication of cancer chemotherapy and radiotherapy, occurring in about 40 percent of patients. Patients treated with radiation therapy for head and neck cancer typically receive an approximately 200 centigray daily dose of radiation, five days per week, for 5 to 7 continuous weeks. Almost all such patients will develop oral mucositis.

The development of Grade III mucositis warrants stoppage of radiotherapy as further injury to the mucosa causes permanent injury to the mucosa. Resolutions occurs 3 to 6weeks after completion of radiotherapy. In cases of severe oral morbidity, the patient may no longer be able to continue cancer therapy; treatment is then usually discontinued. These disruptions in dosing due to oral complications can directly affect patient survivorship.

A wide variety of validated scales have been used to record the extent and severity of oral mucositis in clinical practice and research including the Oral Mucositis Assessment Scale (OMAS) and Patient Reported Oral Mucositis Symptom (PROMS) will be used for the assessment and follow up of the cases. The Radiation Therapy Oncology Group (RTOG) has developed the Acute Radiation Morbidity Scoring Criteria for the evaluation of Radiotherapy treatments. The RTOG grading is reliant on a ability of clinician to judge the anatomical changes associated with oral mucositis (size and characteristics of ulceration)and shall be used for assessing the inclusion of cases in this study.

Research shows many agents have been tested for prevention and treatment of mucositis: oral glutamine supplementation, sucralfate, steroids, immunoglobulin, amifostine, antibiotic lozenges, chlorhexidine rinses, vitamin E, salt and soda mouthwash, but none of them showed optimal symptom relief and reduction in the intensity or duration of the lesions.Thus, there is a need for alternative therapeutic approaches.

 Thus, fundamental and clinical research studies in Homoeopathy suggest that homoeopathy treatment can influence the prognosis and quality of life in cancer patients and also help in managing the repercussions of conventional cancer treatment. However, systematic studies having statistical rigor are lacking. As individualised homoeopathy has not been evaluated for treatment induced mucositis, this exploratory study is proposed.