Randomised controlled trial to test the efficacy of herbal mouth wash in managing acute toxicity of radiation in Head & Neck cancer patients

Introduction

Oral mucositis is the major dose limiting side effect for patients with oral cancer undergoing radiotherapy.  Mucositis  can interfere with the patient’s ability to maintain adequate intake of food and liquids.  Severe mucositis can lead to treatment interruptions or premature termination of therapy resulting in poor tumour control and survival.  All patients undergoing radiotherapy to oral cavity develop some degree of mucositis

Several agents have been tried to minimize the severity of oral mucositis.  But so far, no method has mentioned has been found to be effective. Regional Cancer Centre, Trivandrum has done a study earlier using an ayurvedic mouth wash containing 5 plant ingredients-Emblica officinalis (dried fruit), Terminalia chebula (dried fruit), Terminalia bellerica (dried fruit), Azadiracta indica (leaf & Bark), Glycyrrhiza glabra (root) in patients undergoing radiotherapy for oral cancer¹. One hundred and forty eight patients were randomly assigned to use ayurvedic mouth wash or the standard practice of soda / saline mouthwash. 

The ayurvedic mouth wash delayed the onset of oral mucositis during radiotherapy. Oral hygiene was significantly better in patients using ayurvedic mouth wash. Analgesic  and antibiotic requirements were also low in these patients.  There was a significant decrease in the late side effects of radiation to the oral cavity such as dryness of mouth, intolerance to spicy food in the patients who used ayurvedic  mouthwash. Use of this mouth wash did not affect the response to radiotherapy in  these patients.

The major drawback of this mouth wash was the process of preparation of the mouth wash by the patient and also the shelf life.  In order to overcome this RCC in collaboration with RGCB and Ceego Labs Pvt Ltd, Chennai has developed mouth wash using the same ingredients with the same quantity in two forms; one as a ready to use liquid form and another one in a powder form which can be dissolved in water and can be used.

Aim    

To find out whether these two forms of mouth wash is useful in minimizing the side effects of radiation in patients undergoing radiotherapy for Head & Neck Cancers

Methodology

            Patients with oral cancer undergoing radical / adjuvant radiotherapy with or without surgery will be randomized into 3 arms after getting informed consent.  Those who require adjuvant chemoradiation will not be included.  However, induction chemotherapy is not an exclusion criteria.  One arm will be using the liquid form of mouthwash 5 ml dissolved in 20 ml of water.  Second one will be using mouth wash prepared by dissolving 30 gm of the powder dissolved in 300 ml of water and the control arm will be using the soda saline mouthwash.  All patients will be advised to rinse the mouth with the mouth wash 4 times daily during the entire course of radiotherapy treatment. 

            All these patients will be evaluated weekly. Mucositis grade will be expressed on a 5-point scale using RTOG / ECOG scoring system.  The intensity of pain, dryness of mouth, alteration and taste will be scored on a 10 – point scale using a Visual Analogus Scale (VAS).   The use of analgesics, antibiotics and antifungal and oral hygiene will be recorded in a structured proforma.    Measurements of Weight (Wt) will be done before and after radiotherapy.  All these patients will be reviewed 6 weeks following the treatment to evaluate the degree of xerostomia, intolerance to spicy food and the tumour response.

The sample size is calculated based on the previous study.  Assuming 80% power, 5% and error sample size required is 43 in each arm

Reference

1.    R Kunnambath, D Ravindran, R R Kumar, R.Muwonge, R.M. Pillai. Management of Radiation-Induced Oral Mucositis With a Herbal Mouthwash. Int J Radiat Oncol Biol Phys.2013; 87(Supplement 2): S 143.