Head and Neck CancerNCT03013699
Diet Intervention, Head and Neck Cancer, Feasibility
A study testing Cruciferous and Dark Leafy Green Intervention and Usual Dietary Care in people with Head and Neck Cancer, run by University of Alabama at Birmingham.
Trial summary
This study will examine the effects of a dietary intervention in post-treatment head and neck cancer survivors on the ability to function physically, tiredness, and quality of life, as well as on changing markers in the blood that are associated with better recurrence and survival. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Cruciferous and Dark Leafy Green Intervention and Usual Dietary Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Sep 2016
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will be eligible to participate if they are 1) diagnosed with Stage I - IV oral, hypopharyngeal, nasopharyngeal, oropharyngeal, or laryngeal cancer; 2) age 19+; 3) at least 6 months - 2 years post-treatment; 4) able to consume foods orally; 5) no evidence of disease; 6) English-speaking
Who cannot join
- Patients will not be eligible to participate if they have 1) dementia or organic brain syndrome; 2) severe emotional distress; 3) active schizophrenia; 3) another diagnosis of cancer in the past five years (not including skin or cervical cancer in situ)
About this study
Official title: Improving Dietary Patterns in Head and Neck Cancer Survivors to Optimize Disease Outcomes and Supportive Care: A Pilot/Feasibility Intervention Study
This study will examine the effects of a dietary intervention in post-treatment head and neck cancer survivors on the ability to function physically, tiredness, and quality of life, as well as on changing markers in the blood that are associated with better recurrence and survival.
- Conditions
- Head and Neck Cancer
- Being tested
- Cruciferous and Dark Leafy Green Intervention, Usual Dietary Care
- Keywords
- diet, nutrition, survival, recurrence, cruciferous, dark leafy greens
- Medical subject headings
- Head and Neck Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cruciferous and Dark Leafy Green InterventionBehavioural
Participants receive individual dietary counseling from a Registered Dietitian who will focus on increasing intake of cruciferous and green leafy vegetables while addressing any disease- and treatment-related eating difficulties experienced by the participant.
Usual Dietary CareBehavioural
Participants receive standard educational materials that focus on healthy eating for cancer survivors and the opportunity to briefly discuss nutrition-related concerns with the Registered Dietitian weekly.
| Study group | Role | What they receive |
|---|---|---|
| Usual Dietary Care | Active comparator | Participants receive standard educational materials that focus on healthy eating for cancer survivors and the opportunity to briefly discuss nutrition-related concerns with the Registered Dietitian weekly. Receives: Behavioral: Usual Dietary Care |
| Cruciferous and Dark Leafy Green Intervention | Experimental | Participants receive individual dietary counseling from a Registered Dietitian who will focus on increasing intake of cruciferous and green leafy vegetables while addressing any disease- and treatment-related eating difficulties experienced by the participant. Receives: Behavioral: Cruciferous and Dark Leafy Green Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients excluded or not agreeing to participate
Feasibility measure
Measured: Baseline
Adherence to study protocol activities (research records and diet intake self-report)
Feasibility measure (e.g., percent of assessments completed, percent of counseling phone calls completed, servings of cruciferous vegetables eaten, etc.)
Measured: Throughout 12 week study period
Attrition rates
Feasibility measure
Measured: Throughout 12 week study period
Adverse events with reporting according to institutional review board policy
Measured: Throughout 12 week study period
Questionnaire
Participant satisfaction
Measured: At conclusion of 12 week study period
Questionnaire
Intervention preferences
Measured: At conclusion of 12 week study period
Secondary outcomes (5)
DNA methylation
Measured: At beginning and end of 12 week study period
Serum cytokines
Measured: At beginning and end of 12 week study period
Quality of life (assessed using the Functional Assessment of Cancer Therapy Head and Neck index)
Measured: At beginning and end of 12 week study period
Total energy and nutrient intakes
Measured: At beginning and end of 12 week study period
Covariates
A questionnaire will collect a set of covariates used in the analyses (i.e., these do not represent individual outcomes; this is a group of covariates used in the data analyses). This group includes demographic characteristics (age, sex, race, ethnicity, education, income); lifestyle behaviors (tobacco use, alcohol consumption, exercise); medical history; cancer-specific clinical variables (tumor site, cancer stage, treatment modality); anthropometrics (height and weight)
Measured: At beginning of 12 week study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startJan 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Q. Rogers, MD, MPH, University of Alabama at Birmingham
- Investigators
- Laura Q. Rogers, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03013699
- Sponsor's protocol ID
- X140813004
- Status last verified
- Jan 2017
- First submitted
- 3 Jan 2017
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Dietary Patterns in Head and Neck Cancer Survivors to Optimize Disease Outcomes and Supportive Care: A Pilot/Feasibility Intervention Study
- ClinicalTrials.gov ID
- NCT03013699
- Acronym / sponsor ID
- X140813004
- Conditions
- Head and Neck Cancer
- Keywords
- diet, nutrition, survival, recurrence, cruciferous, dark leafy greens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 6 Jan 2017 (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 study will examine the effects of a dietary intervention in post-treatment head and neck cancer survivors on the ability to function physically, tiredness, and quality of life, as well as on changing markers in the blood that are associated with better recurrence and survival.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Dietary Care | Active comparator | Behavioral: Usual Dietary CareParticipants receive standard educational materials that focus on healthy eating for cancer survivors and the opportunity to briefly discuss nutrition-related concerns with the Registered Dietitian weekly. |
| Cruciferous and Dark Leafy Green Intervention | Experimental | Behavioral: Cruciferous and Dark Leafy Green InterventionParticipants receive individual dietary counseling from a Registered Dietitian who will focus on increasing intake of cruciferous and green leafy vegetables while addressing any disease- and treatment-related eating difficulties experienced by the participant. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients will be eligible to participate if they are 1) diagnosed with Stage I - IV oral, hypopharyngeal, nasopharyngeal, oropharyngeal, or laryngeal cancer; 2) age 19+; 3) at least 6 months - 2 years post-treatment; 4) able to consume foods orally; 5) no evidence of disease; 6) English-speaking
Key exclusion criteria (1 listed)
- Patients will not be eligible to participate if they have 1) dementia or organic brain syndrome; 2) severe emotional distress; 3) active schizophrenia; 3) another diagnosis of cancer in the past five years (not including skin or cervical cancer in situ)
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 |
|---|---|---|
| Cruciferous and Dark Leafy Green InterventionParticipants receive individual dietary counseling from a Registered Dietitian who will focus on increasing intake of cruciferous and green leafy vegetables while addressing any disease- and treatment-related eating difficulties experienced by the participant. | Behavioural | Cruciferous and Dark Leafy Green Intervention |
| Usual Dietary CareParticipants receive standard educational materials that focus on healthy eating for cancer survivors and the opportunity to briefly discuss nutrition-related concerns with the Registered Dietitian weekly. | Behavioural | Usual Dietary Care |
Primary outcome
Number of patients excluded or not agreeing to participate
Time frame: Baseline
Feasibility measure
Adherence to study protocol activities (research records and diet intake self-report)
Time frame: Throughout 12 week study period
Feasibility measure (e.g., percent of assessments completed, percent of counseling phone calls completed, servings of cruciferous vegetables eaten, etc.)
Attrition rates
Time frame: Throughout 12 week study period
Feasibility measure
Adverse events with reporting according to institutional review board policy
Time frame: Throughout 12 week study period
Questionnaire
Time frame: At conclusion of 12 week study period
Participant satisfaction
Questionnaire
Time frame: At conclusion of 12 week study period
Intervention preferences
5 secondary outcomes
DNA methylation
Time frame: At beginning and end of 12 week study period
Serum cytokines
Time frame: At beginning and end of 12 week study period
Quality of life (assessed using the Functional Assessment of Cancer Therapy Head and Neck index)
Time frame: At beginning and end of 12 week study period
Total energy and nutrient intakes
Time frame: At beginning and end of 12 week study period
Covariates
Time frame: At beginning of 12 week study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
- 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.
Laura Q. Rogers, MD principal investigator
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
A study testing Cruciferous and Dark Leafy Green Intervention and Usual Dietary Care in people with Head and Neck Cancer, run by University of Alabama at Birmingham.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of patients excluded or not agreeing to participate (time frame: Baseline). The study lists 6 primary outcomes in all. 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 6 Jan 2017.