Study on the effect of Yashtimadhu ghee for minimizing the radiation toxicity in patients of oropharyngeal cancer.

Phase 3

Not yet recruiting

• Conditions: Malignant neoplasm of oropharynx, (2) ICD-10 Condition: C10||Malignant neoplasm of oropharynx,

• Registration Number: CTRI/2020/06/025757
• Lead Sponsor: Investigator initiated project

Brief Summary

**A RANDOMIZED CONTROLLED TRIAL TO EVALUATE THE EFFICACY OF YASHTIMADHU GHRITA APPLICATION FOR MINIMIZING THE RADIATION INDUCED TOXICITY IN PATIENTS WITH OROPHARYNGEAL SQUAMOUS CELL CARCINOMA**

Advancement in modern diagnostic techniques and cancer therapies has considerably reduced the morbidity and mortality of cancer. Yet, there are a lot of proven side effects for the conventional chemo and radiation therapy.

To minimize the radiation induced toxicities and to improve the quality of life of patients, an integrative approach is always promising. Yashtimadhughrita is a ghee based formulation mentioned in classical ayurvedic text named Chakradutta for sadyakshata vrana (An acute inflammatory condition associated with injury) was chosen as the trial formulation.

**PURPOSE OF THE STUDY**

To evaluate the efficacy of yashtimadhughrita application for minimizing the radiation induced toxicity in patients with oropharyngeal squamous cell carcinoma.

**OBJECTIVES**

**To assess the effectiveness of the Ghrita**

·        In controlling oral mucositis

·        In controlling pain

·        In minimising antibiotic and anti fungal requirements

·        In reducing analgesic usage

·        In reducing radiation induced dryness

·        In improving oral hygiene

Biopsy proven oropharyngeal squamous cell carcinoma patients will be recruited from the OPD of Head & Neck Specialty clinic, Regional Cancer Centre, Trivandrum. 48 Patients will be randomized into intervention and control group using a computer generated randomization table. Patients in the intervention arm will be advised to smear yashtimadhu ghrita in their oral and oropharyngeal areas  4 times daily for a period of 4 weeks after the radical radiation therapy/chemo radiation along with the conventional standard of care.

Those in control arm will be given conventional standard of care

Recruited patients will undergo CBC, FBS, Lipid profile tests at the start of the study and after a period of 1 month.

All these patients will be evaluated at the beginning of the study, after 2weeks, 4 weeks and on a follow up after 6 months from the date of last treatment by a single clinician who is blinded to the randomization procedure (Blinded assessor) using Radiation Therapy Oncology Group(RTOG) grading for assessing mucositis , pain intensity and Xerostomia will be assessed on a 10-point scale using a Visual Analogous Scale (VAS).Analgesics use among these patients will be assessed on the basis of WHO step ladder analgesic requirement scale. Antibiotic and antifungal requirements will be assessed. Oral hygiene will be assessed using Oral Hygiene Index (OHI). All the findings will be tested statistically using Friedman’s test and Wilcoxon-Signed Rank Test. The information collected will be analysed and published.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-05-30
• Study Start: 2020-06-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Patients who had undergone radical radiation therapy/ chemo radiation for carcinoma oropharynx.

Exclusion Criteria

1.Patients diagnosed with diabetes mellitus 2.Presenting with trismus 3.Patients who are not willing to give informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the effectiveness of the Ghrita	Day 1,15 days, 28 days and follow up after 6 month.
In controlling oral mucositis	Day 1,15 days, 28 days and follow up after 6 month.
In controlling pain	Day 1,15 days, 28 days and follow up after 6 month.
In minimising antibiotic and anti fungal requirements	Day 1,15 days, 28 days and follow up after 6 month.
In reducing analgesic usage	Day 1,15 days, 28 days and follow up after 6 month.
In reducing radiation induced dryness	Day 1,15 days, 28 days and follow up after 6 month.
In improving oral hygiene	Day 1,15 days, 28 days and follow up after 6 month.

Trial Locations

Locations (1)

Regional Cancer Centre; 🇮🇳 Thiruvananthapuram, KERALA, India

Regional Cancer Centre

🇮🇳Thiruvananthapuram, KERALA, India

Dr K Ramadas

Principal investigator

9447042309

ramdasrcc@gmail.com