Xerostomia Clinical Trial
Official title:
Coconut Oil as a Novel Approach to Managing Radiation-Induced Xerostomia: An Interventional Study
Verified date | April 2018 |
Source | Ottawa Hospital Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 30 |
Est. completion date | September 15, 2018 |
Est. primary completion date | June 15, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Canada | The Ottawa Hospital | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
Ottawa Hospital Research Institute |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Quality of Life | Mean changes in Quality of Life Scores as measured by the Xerostomia-related quality of life scale (XeQOLS). - Subjective changes in speech quality, dysphagia, and sleep quality. |
3 months | |
Secondary | 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). | Sleep Quality | 3 months | |
Secondary | Speech as assessed clinically at follow up appointment and as measured by the Xerostomia-related quality of life scale (XeQOLS). | Quality of speech | 3 months | |
Secondary | Dysphagia as assessed clinically at follow up appointment and by way of the XeQOLS. | Degree | 3 months | |
Secondary | Coconut Oil | Quantity and Frequency of Use as determined by diary entries. | 2 weeks or more |
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