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NCT Number: NCT05798780

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Oral Cavity Cancer Head and Neck Neoplasms Hypopharyngeal Neoplasms Hypopharynx Cancer Laryngeal Diseases Laryngeal Neoplasms Larynx Cancer Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Oropharyngeal Neoplasms Oropharynx Cancer Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ENHANCE Intervention - Exercise and Nutrition

Behavioral

During radiation, participants will attend in-person supervised resistance training sessions once a week for 7 weeks, followed by 2 ZOOM video conference supervised resistance training sessions every week for 5 weeks, after radiation. Sessions will last approximately 30 minutes. During radiation, participants will be provided 15 meals each week for 7 weeks, 105 meals total. Participants will be asked to participate in 1 weekly dietary coaching session (in-person during radiation and video conference following radiation), create weekly SMART goals, follow an alternative Mediterranean diet pattern, and log all meals, snacks, and supplements consumed for the 12-week intervention.

ENHANCE Intervention - Nutrition Only

Behavioral

During chemoradiotherapy, participants will be provided 15 meals each week for 7 weeks (105 meals total) that will accommodate common NIS concerns (ex. dysphagia and difficulty chewing) following an aMED dietary pattern (5 breakfast, 5 lunch, and 5 dinner), will be taught proper portion size, and will be asked to record percentages of each meal consumed in a provided food journal, in addition to any outside meals, snacks, or nutritional supplements. They will be provided with dietary coaching weekly to discuss NIS, aMED diet compliance, and set weekly SMART goals (approximately 30 min). Following completion of chemoradiotherapy (5 weeks), participants will be provided dietary coaching weekly (in-person or via videoconference), discuss NIS, aMED diet compliance at home, and set weekly SMART goals (30 min). Trainers will monitor participants' Fitbit active minutes in real time throughout the intervention period and provide aerobic exercise encouragement accordingly.

Primary outcomes

  1. Number of Participants Recruited - Feasibility

    Time frame: 12 Months

    The study will be deemed feasible if ≥ 60% of eligible participants are enrolled

  2. Number of Participants who Complete Questionnaire - Retention - Feasibility

    Time frame: 12 weeks

    The study will be deemed feasible if ≥ 70% of participants complete post intervention questionnaire.

  3. Participant Satisfaction of Timeline - Feasibility

    Time frame: 12 weeks

    The study will be deemed feasible if ≥ 70% of participants like the timing of the intervention using a likert scale (scale range Strongly agree to Strongly disagree)

  4. Participant Average Attendance - Assessment Completion - Adherence

    Time frame: 12 weeks

    Participant assessment completion will be deemed successful if participant average attendance is ≥10 weeks of sessions (out of 12)

  5. Number of Participants who Complete Task/Goals - Adherence

    Time frame: 12 weeks

    Study adherence will be deemed successful if ≥70% of participants report weekly tasks/goals adherence (e.g., gym and diet)

  6. Participant Satisfaction Assessed with 5 Point Scale - Acceptability

    Time frame: 12 weeks

    Participants satisfaction will be measured using a 5 point scale (1 is the lowest, 5 is the highest) exit survey administered at the post-intervention follow-up.

  7. Participant Intent to Continue Assessed with 5 Point Scale - Acceptability

    Time frame: 12 weeks

    Participants intent to continue will be measured using a 5 point scale (1 is the lowest, 5 is the highest) exit survey administered at the post-intervention follow-up.

  8. Participant Knowledge Gained Assessed with 5 Point Scale - Acceptability

    Time frame: 12 weeks

    Participants knowledge gained will be measured using a 5 point scale (1 is the lowest, 5 is the highest) exit survey administered at the post-intervention follow-up.

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Registry information

Official study title

The ENHANCE Study: Exercise and Nutrition in Head And Neck CancEr Survivors: A Randomized Clinical Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Apr 5, 2023
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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