Coconut Oil: Managing Radiation-Induced Xerostomia

NCT03176368 | Unknown

• 1 other identifier: 20170139-01H
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study will seek to assess the experience of using of coconut oil as an approach to managing radiation-induced xerostomia in patients previously treated for cancer in the head and neck. There is a high prevalence of radiation-induced xerostomia in this patient population, and the condition has significant negative impact on patients' quality of life. There is currently no agreed-upon standard of care for the treatment of this condition. Anecdotal evidence from patients and both physicians and allied healthcare providers suggests improvement in this condition with the use of coconut oil, but this has not previously been formally studied. We therefore propose a case series study to formally assess the tolerability and efficacy of coconut oil as an approach to managing radiation-induced xerostomia.

Conditions

Xerostomia

Keywords

dry mouth; coconut oil; radiation

Outcome Measures

Primary Outcomes (1)

• Subjective benefit

  Our primary outcome of interest will be descriptive in nature, namely whether patients find subjective benefit from the use of coconut oil, as evidenced by its continued use throughout the study period. This will be appraised qualitatively by analyzing diary entries.

  3 months

Secondary Outcomes (5)

• Quality of Life

  3 months

• Change in Activities of Daily Living as assessed clinically at follow up appointment and as measured by the Xerostomia-related quality of life scale (XeQOLS).

  3 months

• Speech as assessed clinically at follow up appointment and as measured by the Xerostomia-related quality of life scale (XeQOLS).

  3 months

• Dysphagia as assessed clinically at follow up appointment and by way of the XeQOLS.

  3 months

• Coconut Oil

  2 weeks or more

Study Arms (1)

Coconut Oil

EXPERIMENTAL

Through a interventional/cohort design, we propose to study the experience of coconut oil over a three month period, allowing patients to use Biotene© oral lubricant (or another product of their choice) as an alternative to coconut oil if they so prefer.

Other: Coconut Oil

Interventions

Coconut Oil OTHER

Coconut Oil

Also known as: Natural Product

Coconut Oil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has completed treatment for head and neck cancer at least 18 months prior to entry to the study.
• Patient has experienced xerostomia following completion of radiation treatment.
• Patient has received external beam radiation at a dose of at least 50 Gy to the head and neck.
• Patients able to read / understand English.
• Patients who are competent/willing to consent to the study.
• Patients willing to comply with protocol and study schedule.

You may not qualify if:

• Patient currently undergoing treatment for head and neck cancer.
• Patient has previously used coconut oil for the treatment of xerostomia.
• Patient with allergy/sensitivity to coconut.
• Patient cannot read/ understand English.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H8L6, Canada

Location

MeSH Terms

Conditions

Xerostomia

Interventions

Coconut Oil; Biological Products

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats; Fats; Lipids; Plant Oils; Oils; Complex Mixtures

Study Officials

• Stephanie Johnson-Obaseki, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: June 5, 2017
• Study Start: October 5, 2017
• Primary Completion: June 15, 2018
• Study Completion: September 15, 2018
• Last Updated: April 17, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)