Coconut Oil: Managing Radiation-Induced Xerostomia
Primary Purpose
Xerostomia
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Coconut Oil
Sponsored by
About this trial
This is an interventional supportive care trial for Xerostomia focused on measuring dry mouth, coconut oil, radiation
Eligibility Criteria
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.
Sites / Locations
- The Ottawa Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Coconut Oil
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
Speech as assessed clinically at follow up appointment and as measured by the Xerostomia-related quality of life scale (XeQOLS).
Quality of speech
Dysphagia as assessed clinically at follow up appointment and by way of the XeQOLS.
Degree
Coconut Oil
Quantity and Frequency of Use as determined by diary entries.
Full Information
NCT ID
NCT03176368
First Posted
May 1, 2017
Last Updated
April 13, 2018
Sponsor
Ottawa Hospital Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT03176368
Brief Title
Coconut Oil: Managing Radiation-Induced Xerostomia
Official Title
Coconut Oil as a Novel Approach to Managing Radiation-Induced Xerostomia: An Interventional Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 5, 2017 (Actual)
Primary Completion Date
June 15, 2018 (Anticipated)
Study Completion Date
September 15, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Xerostomia, or dry mouth, is a common complication in patients treated with radiotherapy for cancer of the head and neck, having been cited as occurring to some degree in 60- 100% of patients. Radiation, either alone or in addition to surgery, is a mainstay in the treatment of head and neck cancer. The incidence and degree of xerostomia as a side-effect is proportional to both the dosage of radiation used, and the amount of salivary gland tissue included in the radiation field. The downstream effects of xerostomia are wide-ranging, and can include difficulty chewing, swallowing, impaired phonation, altered taste sensation, dental carries, oropharyngeal candidiasis, systemic malnutrition and weight loss. Several studies have demonstrated a significant negative impact of xerostomia on patient quality of life. With cancer of the head and neck being the sixth most commonly diagnosed cancer worldwide, the burden of xerostomia on both the healthcare system and patient quality of life should not be underestimated.
There is no single effective treatment for radiation-induced xerostomia. Current treatments are non-specific, and directed at alleviating symptoms. These include lifestyle modifications (such as discontinuation of smoking, dairy, and other dietary products that thicken saliva), artificial saliva preparations, and parasympathetic agents such as pilocarpine which stimulate saliva production. Artificial saliva preparations such as Biotene© oral lubricant are commonly used today. However many of these treatments have limited efficacy, are costly, and the use of pilocarpine in particular is associated with significant side-effects. Other therapies which have been studied but not definitively proven effective include acupuncture and hyperbaric oxygen. Submandibular gland transfer, first described in 2000 and subsequently demonstrated in 2001, has also been shown to be effective in preventing xerostomia, however is a highly specialized procedure which prolongs the length of surgery, with benefit in only a limited patient population. Of these potential treatments, certainly Biotene© is the most common method of alleviating xerostomia. Preliminary evidence in the form of a phase II study has demonstrated the efficacy of Biotene© in alleviating symptoms of xerostomia in patients who have undergone radiation for head and neck cancer. The use of Biotene© is common practice at our tertiary care hospital, The Ottawa Hospital (TOH) although it is not agreed upon as THE standard of care.
Coconut oil, defined by Health Canada as a natural health / food product, has been anecdotally suggested to ameliorate the symptoms of xerostomia following radiation treatment for head and neck cancer. This anecdotal evidence has been derived from discussion with both patients and healthcare providers at The Ottawa Hospital. Both patients and allied health care providers involved in the care of patients following radiation treatment for head and neck cancer have attested to the beneficial effects of coconut oil. However, the effects of coconut oil in the management of radiation-induced xerostomia in patients previously treated for cancer of the head and neck have not been formally studied.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerostomia
Keywords
dry mouth, coconut oil, radiation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Coconut Oil
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Coconut Oil
Other Intervention Name(s)
Natural Product
Intervention Description
Coconut Oil
Primary Outcome Measure Information:
Title
Subjective benefit
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Quality of Life
Description
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.
Time Frame
3 months
Title
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).
Description
Sleep Quality
Time Frame
3 months
Title
Speech as assessed clinically at follow up appointment and as measured by the Xerostomia-related quality of life scale (XeQOLS).
Description
Quality of speech
Time Frame
3 months
Title
Dysphagia as assessed clinically at follow up appointment and by way of the XeQOLS.
Description
Degree
Time Frame
3 months
Title
Coconut Oil
Description
Quantity and Frequency of Use as determined by diary entries.
Time Frame
2 weeks or more
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Johnson-Obaseki, MD
Organizational Affiliation
The Ottawa Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H8L6
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Coconut Oil: Managing Radiation-Induced Xerostomia
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