XerostomiaNCT03176368
Coconut Oil: Managing Radiation-Induced Xerostomia
A study testing Coconut Oil in people with Xerostomia, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Xerostomia
- What is being tested?
- Coconut Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 5 Oct 2017to 15 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Coconut Oil as a Novel Approach to Managing Radiation-Induced Xerostomia: An Interventional Study
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.
Read the 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.
- Conditions
- Xerostomia
- Being tested
- Coconut Oil
- Keywords
- dry mouth, coconut oil, radiation
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coconut OilOther
Also called Natural Product
Coconut Oil
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Coconut Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (5)
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.
Measured: 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).
Sleep Quality
Measured: 3 months
Speech as assessed clinically at follow up appointment and as measured by the Xerostomia-related quality of life scale (XeQOLS).
Quality of speech
Measured: 3 months
Dysphagia as assessed clinically at follow up appointment and by way of the XeQOLS.
Degree
Measured: 3 months
Coconut Oil
Quantity and Frequency of Use as determined by diary entries.
Measured: 2 weeks or more
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start5 Oct 2017
- Primary completion15 Jun 2018 (estimated)
- Study completion15 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for XerostomiaStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Johnson-Obaseki, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176368
- Sponsor's protocol ID
- 20170139-01H
- Status last verified
- Apr 2018
- First submitted
- 1 May 2017
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coconut Oil as a Novel Approach to Managing Radiation-Induced Xerostomia: An Interventional Study
- ClinicalTrials.gov ID
- NCT03176368
- Acronym / sponsor ID
- 20170139-01H
- Conditions
- Xerostomia
- Keywords
- dry mouth, coconut oil, radiation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 5 Oct 2017 (actual)
- Primary completion
- 15 Jun 2018 (estimated)
- Study completion
- 15 Sep 2018 (estimated)
- First posted
- 5 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coconut Oil | Experimental | Other: Coconut OilThrough 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coconut OilAlso: Natural ProductCoconut Oil | Other | Coconut Oil |
Primary outcome
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.
5 secondary outcomes
Quality of Life
Time frame: 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).
Time frame: 3 months
Speech as assessed clinically at follow up appointment and as measured by the Xerostomia-related quality of life scale (XeQOLS).
Time frame: 3 months
Dysphagia as assessed clinically at follow up appointment and by way of the XeQOLS.
Time frame: 3 months
Coconut Oil
Time frame: 2 weeks or more
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Johnson-Obaseki, MD principal investigator
The Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coconut Oil in people with Xerostomia, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective benefit (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.