MucositisPhase 1/2NCT02575313
The Effects of Whole Food Intervention on Mucositis in Patients Treated for Head and Neck Cancer
A Phase 1/2 study testing Whole Food Intervention in people with Mucositis, run by Providence Health & Services at 2 sites in United States.
Trial summary
This is a study to see if a Whole Food Intervention (WFI) consisting of yogurt, butter, honey, vanilla, and glutamine will lower the frequency or severity of mucositis in head and neck cancer patients undergoing standard treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mucositis
- What is being tested?
- Whole Food Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2009to Sep 2012
- Phase
- Phase 1/2
- 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
- Histopathologically confirmed diagnosis of head \& neck carcinoma
- Scheduled to undergo continuous daily course of radiation therapy with or without chemotherapy
- No other serious concurrent medical illness as determined by the Principle Investigator
- Absolute neutrophil count ≥ 500/mm3
- Platelet count ≥ 50,000/mm3
- No history of insulin-dependent diabetes mellitus
- No prior hypersensitivity reaction to compound components
Who cannot join
- Dislike of the available forms of the WFI
- Allergy or food intolerance relevant to the ingredients
- Lack of access to refrigerated storage for the WFI
- Inability or unwillingness to participate twice a week
- Inability to swallow
- Undergoing treatment for HIV with HIV medications
- Ongoing alcohol and/or drug abuse
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Oregon Clinic, Providence Portland Cancer Center
Portland, Oregon, 97213
Integrative Medicine Program, Providence St. Vincent Medical Center
Portland, Oregon, 97225
About this study
Official title: The Effects of Whole Food Intervention on Mucositis in Patients Being Treated for Head and Neck Cancer With Radiation With or Without Chemotherapy
This is a study to see if a Whole Food Intervention (WFI) consisting of yogurt, butter, honey, vanilla, and glutamine will lower the frequency or severity of mucositis in head and neck cancer patients undergoing standard treatment.
Read the detailed description
The proposal is a one center, open label, randomized pilot study to evaluate the safety, tolerability and compliance of a Whole Food Intervention with Standard of Care for patients with head \& neck cancer. The primary objectives are:
- To determine whether patients will use a Whole Food Intervention 4-6 times daily, and
- To determine whether the Whole Food Intervention will reduce the incidence of grade 2 or greater mucositis from 75% historically seen to 25% .
- To determine whether Whole Food Intervention will reduce the incidence of treatment breaks from >19% to < 10% (see section 9 for comments)
This Whole Food Intervention will be taken by mouth before the start of radiation therapy, with or without chemotherapy and for the entire treatment therapy.
Mucositis-related pain and reduction of oral intake will be quantified by using validated assessment tools. Weight loss or gain, diarrhea, constipation or no change in bowel function and the use of conventional medication for radiation-induced mucositis will be recorded. Chart review and patient questionnaires will be used to establish whether a treatment break or dose reduction for radiation of chemotherapy was required due to radiation mucositis-related symptoms. Complete Chemistry Profile and Complete Blood Count will be extracted from the patients' medical oncologist's or radiation oncologist's records. The patient will continue to use standard mucositis therapies if desired as prescribed by the treating oncology physician.
The Whole Food Intervention consists of yogurt, butter, honey, vanilla, and glutamine with 3 portioning cups, equal to approximately 12 ounces, taken daily before starting radiation therapy. A questionnaire will be used to record symptoms and doses taken. The patient will continue to use standard mucositis therapies as prescribed by the treating oncology physician.
- Conditions
- Mucositis
- Being tested
- Whole Food Intervention
- Keywords
- L-Glutamine, chemotherapy, radiotherapy, therapeutic toxicity
- Medical subject headings
- Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Food InterventionDietary supplement
A combination of honey, glutamine, probiotics, and butter was administered to participants undergoing cancer.
| Study group | Role | What they receive |
|---|---|---|
| Whole Food Intervention Treated | Experimental | Group of participants given the experimental WFI along with standard cancer treatment. Receives: Dietary Supplement: Whole Food Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Tolerability
Estimated portion consumption on a daily basis was obtained to determine if the WFI could be tolerated by participants.
Measured: Eight (8) weeks
Secondary outcomes (2)
Mucositis Grading
Mucositis grade was calculated using established criteria.
Measured: Eight (8) weeks
Treatment Break Measurement
To determine whether Whole Food Intervention will reduce the incidence of treatment breaks from ≥19% to ≤10%.
Measured: Eight (8) weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study startOct 2009
- Primary completionSep 2012
- Study completionSep 2012
Why it stopped: Lack of participant recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MucositisStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miles H Hassell, MD, Principal investigator, Providence Health & Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02575313
- Sponsor's protocol ID
- 07-173B
- Status last verified
- Oct 2015
- First submitted
- 25 Sep 2015
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Whole Food Intervention on Mucositis in Patients Being Treated for Head and Neck Cancer With Radiation With or Without Chemotherapy
- ClinicalTrials.gov ID
- NCT02575313
- Acronym / sponsor ID
- 07-173B
- Conditions
- Mucositis
- Keywords
- L-Glutamine, chemotherapy, radiotherapy, therapeutic toxicity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of participant recruitment.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 14 Oct 2015 (estimated)
- 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 is a study to see if a Whole Food Intervention (WFI) consisting of yogurt, butter, honey, vanilla, and glutamine will lower the frequency or severity of mucositis in head and neck cancer patients undergoing standard treatment.
Detailed description
The proposal is a one center, open label, randomized pilot study to evaluate the safety, tolerability and compliance of a Whole Food Intervention with Standard of Care for patients with head \& neck cancer. The primary objectives are:
- To determine whether patients will use a Whole Food Intervention 4-6 times daily, and
- To determine whether the Whole Food Intervention will reduce the incidence of grade 2 or greater mucositis from 75% historically seen to 25% .
- To determine whether Whole Food Intervention will reduce the incidence of treatment breaks from >19% to < 10% (see section 9 for comments)
This Whole Food Intervention will be taken by mouth before the start of radiation therapy, with or without chemotherapy and for the entire treatment therapy.
Mucositis-related pain and reduction of oral intake will be quantified by using validated assessment tools. Weight loss or gain, diarrhea, constipation or no change in bowel function and the use of conventional medication for radiation-induced mucositis will be recorded. Chart review and patient questionnaires will be used to establish whether a treatment break or dose reduction for radiation of chemotherapy was required due to radiation mucositis-related symptoms. Complete Chemistry Profile and Complete Blood Count will be extracted from the patients' medical oncologist's or radiation oncologist's records. The patient will continue to use standard mucositis therapies if desired as prescribed by the treating oncology physician.
The Whole Food Intervention consists of yogurt, butter, honey, vanilla, and glutamine with 3 portioning cups, equal to approximately 12 ounces, taken daily before starting radiation therapy. A questionnaire will be used to record symptoms and doses taken. The patient will continue to use standard mucositis therapies as prescribed by the treating oncology physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Whole Food Intervention Treated | Experimental | Dietary Supplement: Whole Food InterventionGroup of participants given the experimental WFI along with standard cancer treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histopathologically confirmed diagnosis of head \& neck carcinoma
- Scheduled to undergo continuous daily course of radiation therapy with or without chemotherapy
- No other serious concurrent medical illness as determined by the Principle Investigator
- Absolute neutrophil count ≥ 500/mm3
- Platelet count ≥ 50,000/mm3
Key exclusion criteria (7 listed)
- Dislike of the available forms of the WFI
- Allergy or food intolerance relevant to the ingredients
- Lack of access to refrigerated storage for the WFI
- Inability or unwillingness to participate twice a week
- Inability to swallow
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 |
|---|---|---|
| Whole Food InterventionA combination of honey, glutamine, probiotics, and butter was administered to participants undergoing cancer. | Dietary supplement | Whole Food Intervention Treated |
Primary outcome
Measurement of Tolerability
Time frame: Eight (8) weeks
Estimated portion consumption on a daily basis was obtained to determine if the WFI could be tolerated by participants.
2 secondary outcomes
Mucositis Grading
Time frame: Eight (8) weeks
Treatment Break Measurement
Time frame: Eight (8) weeks
Results and safety
The study was stopped early (reason given: Lack of participant recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
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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.
Miles H Hassell, MD principal investigator
Providence Health & Services
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Whole Food Intervention in people with Mucositis, run by Providence Health & Services at 2 sites in United States.
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 7 inclusion and 7 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: stopped early, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of participant recruitment.). 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?
Measurement of Tolerability (time frame: Eight (8) weeks). 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 14 Oct 2015.