Topical coconut oil application to improve xerostomia related quality of life.

Not yet recruiting

• Conditions: Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx,

• Registration Number: CTRI/2021/05/033603
• Lead Sponsor: Tata Memorial Centre

Brief Summary

Head & Neck cancers contribute to around 25% of total patients suffering from cancer in India. The burden of head & neck cancers to a large extent can be attribute to abuse of different forms of tobacco used by both Indian males & females. Xerostomia thus is a common feature encountered during & after radiotherapy. The salivary secretion progressively decreases with increase in radiation dose beyond 50Gy. For cure in head & neck cancer doses more than 60Gy are needed though the tolerance of normal organs e.g. salivary glands varies between 32Gy to 40Gy. Out of all the radiation reactions xerostomia is one of the commonest & most troublesome.

Coconut oil, it is derived from the derived from the dried kernel of fatty ripe coconut.  The mechanism of xerostomia relief from coconut oil may be related to its ability to "coat " the mouth, forming a barrier to keep mucosal surface moist. So with this study i would assess the effect of topical of coconut oil application on xerostomia related quality of life among patient with radiation induced xerostomia in H&N cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-31
• Last Update Posted: 2021-11-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 234

Inclusion Criteria

• 1 Age > 18 year & < 65 years of head & neck cancer. 2 After completion of radiation therapy treatment. (Radical radiotherapy). 3 Present at the time of data collection. 4 Willing to participate.
• Patient who can follow the instruction.

Exclusion Criteria

• 1 Patients having allergy to coconut oil.
• 2 Patient receiving palliative radiation therapy.
• 3 Patient with distant metastasis.
• 4 Not willing to participate.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the xerostomia related quality of life among patient with coconut oil application with standard supportive care versus standard supportive care.	Participant will be followed by in every 3 month and weekly video calling assessment by RTOG grading scale and UOW-QOL to assess xerostomia related QOL.

Secondary Outcome Measures

Name	Time	Method
1. To assess the xerostomia related quality of life among patients with xerostomia before & after topical application of coconut with SSC.	2. To assess the xerostomia related quality of life among patient with xerostomia before & after SSC.

Trial Locations

Locations (1)

Tata Memorial Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Tata Memorial Hospital

🇮🇳Mumbai, MAHARASHTRA, India

Dr Meera Sharad Achrekar

Principal investigator

9769993848

meeraachrekar@hotmail.com