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

Not Applicable

Recruiting

• Conditions: Larynx Cancer; Oropharynx Cancer; Oral Cavity Cancer; Hypopharynx Cancer
• Interventions: Behavioral: ENHANCE Intervention - Nutrition Only; Behavioral: ENHANCE Intervention - Exercise and Nutrition

• Registration Number: NCT05798780
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-22
• Study First Submitted QC: 2023-03-22
• Study First Posted: 2023-04-05
• Study Start: 2023-04-06
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-07
• Primary Completion: 2025-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ENHANCE Intervention Diet Only	ENHANCE Intervention - Nutrition Only	Participants will be provided 15 meals each week for 7 weeks 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. 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). Participants will receive a Fitbit to wear continuously 24/7 over 12-weeks to track steps and activity intensity.
ENHANCE Intervention Diet and Excerise	ENHANCE Intervention - Exercise and Nutrition	Participants will participate in 2 in-person supervised resistance training sessions every week for the 7 weeks (during radiation), followed by 2 ZOOM video conference supervised resistance training sessions every week for 5 weeks (after radiation). During radiation, participants will be provided 15 meals each week for 7 weeks. Participants will also attend weekly dietary coaching sessions. Participants will receive a Fitbit to wear continuously 24/7 over 12-weeks to track steps and activity intensity.

Primary Outcome Measures

Name	Time	Method
Participant Intent to Continue Assessed with 5 Point Scale - Acceptability	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.
Participant Knowledge Gained Assessed with 5 Point Scale - Acceptability	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.
Number of Participants who Complete Questionnaire - Retention - Feasibility	12 weeks	The study will be deemed feasible if ≥ 70% of participants complete post intervention questionnaire.
Participant Satisfaction of Timeline - Feasibility	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)
Participant Average Attendance - Assessment Completion - Adherence	12 weeks	Participant assessment completion will be deemed successful if participant average attendance is ≥10 weeks of sessions (out of 12)
Number of Participants who Complete Task/Goals - Adherence	12 weeks	Study adherence will be deemed successful if ≥70% of participants report weekly tasks/goals adherence (e.g., gym and diet)
Participant Satisfaction Assessed with 5 Point Scale - Acceptability	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.
Number of Participants Recruited - Feasibility	12 Months	The study will be deemed feasible if ≥ 60% of eligible participants are enrolled

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States