Coconut Oil: Managing Radiation-Induced Xerostomia
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|ClinicalTrials.gov Identifier: NCT03176368|
Recruitment Status : Unknown
Verified April 2018 by Ottawa Hospital Research Institute.
Recruitment status was: Active, not recruiting
First Posted : June 5, 2017
Last Update Posted : April 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Xerostomia||Other: Coconut Oil||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Coconut Oil as a Novel Approach to Managing Radiation-Induced Xerostomia: An Interventional Study|
|Actual Study Start Date :||October 5, 2017|
|Estimated Primary Completion Date :||June 15, 2018|
|Estimated Study Completion Date :||September 15, 2018|
Experimental: Coconut Oil
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
Other Name: Natural Product
- Subjective benefit [ Time Frame: 3 months ]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.
- Quality of Life [ Time Frame: 3 months ]
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). [ Time Frame: 3 months ]Sleep Quality
- Speech as assessed clinically at follow up appointment and as measured by the Xerostomia-related quality of life scale (XeQOLS). [ Time Frame: 3 months ]Quality of speech
- Dysphagia as assessed clinically at follow up appointment and by way of the XeQOLS. [ Time Frame: 3 months ]Degree
- Coconut Oil [ Time Frame: 2 weeks or more ]Quantity and Frequency of Use as determined by diary entries.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03176368
|The Ottawa Hospital|
|Ottawa, Ontario, Canada, K1H8L6|
|Principal Investigator:||Stephanie Johnson-Obaseki, MD||The Ottawa Hospital|