Active — Not RecruitingNot Applicable

The ENHANCE Study: Exercise and Nutrition in Head And Neck CancEr Survivors

United States40 participantsStarted 2023-04-06

Plain-language summary

The purpose of the study is to design a physical activity and dietary intervention for head and neck cancer patients.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * \>18 years old * Newly diagnosed tumors of the oral cavity, oropharynx, hypopharynx, or larynx * No documented or observable psychiatric or neurological disorders that would interfere with study participation (e.g., dementia, psychosis) * Able to speak and read English * Able to consume food orally * Willing to consume an alternative Mediterranean diet * Scheduled to receive treatment with radiation or chemoradiation * Screened via the Physical Activity Readiness Questionnaire (PAR-Q+) with medical clearance of treating physicians, as necessary * Able to provide informed consent Exclusion Criteria: * Women who are pregnant * Head and Neck Cancer not the primary diagnosis * Patients scheduled to receive surgery * Patients on enteral or parental nutrition

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants Recruited - Feasibility

Timeframe: 12 Months

Number of Participants who Complete Questionnaire - Retention - Feasibility

Timeframe: 12 weeks

Participant Satisfaction of Timeline - Feasibility

Timeframe: 12 weeks

Participant Average Attendance - Assessment Completion - Adherence

Timeframe: 12 weeks

Number of Participants who Complete Task/Goals - Adherence

Timeframe: 12 weeks

Participant Satisfaction Assessed with 5 Point Scale - Acceptability

Timeframe: 12 weeks

Participant Intent to Continue Assessed with 5 Point Scale - Acceptability

Timeframe: 12 weeks

Trial details

NCT IDNCT05798780

SponsorH. Lee Moffitt Cancer Center and Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-13

View on ClinicalTrials.gov More Oral Cavity Cancer trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants Recruited - Feasibility

Timeframe: 12 Months

Number of Participants who Complete Questionnaire - Retention - Feasibility

Timeframe: 12 weeks

Participant Satisfaction of Timeline - Feasibility

Timeframe: 12 weeks

Participant Average Attendance - Assessment Completion - Adherence

Timeframe: 12 weeks

Number of Participants who Complete Task/Goals - Adherence

Timeframe: 12 weeks

Participant Satisfaction Assessed with 5 Point Scale - Acceptability

Timeframe: 12 weeks

Participant Intent to Continue Assessed with 5 Point Scale - Acceptability

Timeframe: 12 weeks