Herbal mouth wash to minimise radiation induced mucositis in head and neck cancer patients

Phase 3

Not yet recruiting

• Conditions: Malignant neoplasms of lip, oral cavity and pharynx,

• Registration Number: CTRI/2020/04/024851
• Lead Sponsor: Regional Cancer Centre Trivandrum

Brief Summary

**Randomised controlled trial totest the efficacy of herbal mouth wash in managing acute toxicity of radiationin Head & Neck cancer patients**

**Introduction**

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

Several agentshave been tried to minimize the severity of oral mucositis.  But so far, no method has mentioned has beenfound to be effective. Regional Cancer Centre, Trivandrum has done a studyearlier using an ayurvedic mouth wash containing 5 plant ingredients-Emblicaofficinalis (dried fruit), Terminalia chebula (dried fruit), Terminalia bellerica(dried fruit), Azadiracta indica (leaf & Bark), Glycyrrhiza glabra (root) inpatients undergoing radiotherapy for oral cancer1. One hundred andforty eight patients were randomly assigned to use ayurvedic mouth wash or thestandard practice of soda / saline mouthwash.

 The ayurvedicmouth wash delayed the onset of oral mucositis during radiotherapy. Oralhygiene was significantly better in patients using ayurvedic mouth wash. Analgesic  and antibiotic requirements were also low inthese patients.  There was a significantdecrease in the late side effects of radiation to the oral cavity such as drynessof mouth, intolerance to spicy food in the patients who used ayurvedic  mouthwash. Use of this mouth wash did notaffect the response to radiotherapy in  these patients.

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

 **Aim**

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

**Methodology**

Patientswith oral cancer undergoing radical / adjuvant radiotherapy with or withoutsurgery will be randomized into 3 arms after getting informed consent.  Those who require adjuvant chemoradiationwill not be included.  However, inductionchemotherapy is not an exclusion criteria. One arm will be using the liquid form of mouthwash 5 ml dissolved in 20ml of water.  Second one will be usingmouth wash prepared by dissolving 30 gm of the powder dissolved in 300 ml ofwater and the control arm will be using the soda saline mouthwash.  All patients will be advised to rinse themouth with the mouth wash 4 times daily during the entire course ofradiotherapy treatment.

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

 The sample sizeis 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 RKumar, R.Muwonge, R.M. Pillai. Management of Radiation-Induced Oral MucositisWith a Herbal Mouthwash. Int J Radiat Oncol Biol Phys.2013; 87(Supplement 2): S143.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-04-23
• Study Start: 2020-04-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

Patients with oral cancer undergoing radical / adjuvant radiotherapy with or without surgery will be included.

Exclusion Criteria

Patients who require adjuvant chemoradiation will not be included.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To find out whether the two forms of mouth wash is useful in minimizing side effects of radiation in patients undergoing radiotherapy for oral cancers in terms of oral hygiene, in minimising oral mucositis and in decreasing the severity of analgesic and antibiotic usage.	At baseline, Weekly, | at the end of radiotherapy treatment and 6 weeks after the treatment

Secondary Outcome Measures

Name	Time	Method
degree of xerostomia, intolerance to spicy food and the tumour response.	6 weeks after the completion of treatment

Trial Locations

Locations (1)

Regional Cancer Centre,Thiruvananthapuram; 🇮🇳 Thiruvananthapuram, KERALA, India

Regional Cancer Centre,Thiruvananthapuram

🇮🇳Thiruvananthapuram, KERALA, India

DrK Ramadas

Principal investigator

9447042309

ramdasrcc@gmail.com