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

H. Lee Moffitt Cancer Center and Research Institute

Status: Active, not recruiting

Conditions: Oropharynx Cancer; Hypopharynx Cancer; Oral Cavity Cancer; Larynx Cancer

Treatments: Behavioral: ENHANCE Intervention - Exercise and Nutrition; Behavioral: ENHANCE Intervention - Nutrition Only

Study type: Interventional

Funder types: Other

Identifiers

NCT05798780

MCC-22330

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 3 patient groups

ENHANCE Intervention Diet and Excerise

Experimental group

Description:

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.

Treatment:

Behavioral: ENHANCE Intervention - Exercise and Nutrition

ENHANCE Intervention Diet Only

Experimental group

Description:

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.

Treatment:

Behavioral: ENHANCE Intervention - Nutrition Only

Usual Care + Fitbit

No Intervention group

Description:

Participants will receive handouts with diet and exercise education. Participants will receive a Fitbit to wear continuously 24/7 over 12-weeks to track steps and activity intensity.