Exercise and Nutritional Prehabilitation for Head and Neck Cancer Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Completion Rate of 2-Week Prehabilitation Program
Study Overview
Brief Summary
This study examines the acceptability, feasibility, and safety in developing a prehabilitation program for head and neck cancer patients. The purpose of this research is to access the safety and acceptability of using a prehabilitation program before head and neck cancer surgery.
Detailed Description
The purpose of this research is to access the safety and acceptability of using a prehabilitation program before head and neck cancer surgery. In this unblinded prospective study we will establish a 2-week prehabilitation program and assess whether this is feasible, acceptable to our patients, and safe. Subjects will be enrolled through August 2025, with a goal of enrolling 20 total subjects. The anticipated duration of each subject's involvement will be approximately 3 months, beginning at the time of their initial consultation and ending approximately 1 month after surgery.
Subjects will sign the informed consent form at initial visit and then receive a 2-week home- based exercise program to follow for the two weeks leading up to their surgical date. This exercise program will be provided both electronically through a link to our study-specific Med Bridge Program. Additionally, a hard-copy/PDF will be provided to the patients who prefer this format. Nutritional goals will be suggested, mainly with protein macronutrient goals defined as at least 1.2-2g/kg of protein per day.
At initial visit and the 1-month post-op visit, Timed Up and Go (TUG) and 6 Minute walk Test (6MWT) will be evaluated.
Subjects will begin the exercise program exactly two weeks (14 days) prior to surgery and will be instructed on their "start date" as soon as a surgical date is secured. Subjects will receive all necessary equipment (pedometer, resistance bands) from the study team, as well as a log-book for recording their compliance. The PI or designated study team-member will confirm with the subject this start-date, and perform weekly follow-up calls on day 7 and day 14 to monitor for any adverse events and compliance. Any report of increased pain related to the exercise program or injury will result in immediate recommendation for medical assessment and withdrawal from the study.
Standard-of-care cancer care will otherwise take place during the prehabilitation period, including any necessary laboratory and imaging testing. No additional testing will be required of the patient. Typically, patients are seen in an initial consultation and if surgery is recommended, preoperative labs and imaging are ordered if clinically necessary. Surgery date is typically within 3-4 weeks of initial consultation. If patients screen positive for malnutrition on the Malnutrition Screening Tool, standard-of-care referral to a dietician will be recommended.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •New head and neck cancer diagnosis Age > 18
Exclusion Criteria
- •Prior treatment for head and neck cancer (surgery and/or radiation)
- •Acute or unstable cardiac conditions (unstable angina or symptomatic severe aortic stenosis)
- •American Society of Anesthesiologists physical status of 4 and 5
- •Disabling orthopedic or neuromuscular disease
- •Cardiac failure (New York Heart Association functional classes III and IV)
- •Severe chronic obstructive pulmonary disease
- •End-stage liver or kidney disease
- •Inability to swallow and/or feeding tube dependence
- •Any other comorbid medical, physical, and/or mental condition that contraindicates exercise or oral nutrition
- •Adults unable to consent
- •Age 17.99 or younger
- •Prisoners, pregnant women, or other vulnerable population
Arms & Interventions
behavioral intervention
The study involves a behavioral intervention (exercise and nutritional prehabilitation) designed to assess outcomes related to feasibility, acceptability, and safety in head and neck cancer patients. Outcomes are being measured following the intervention over a defined period (from diagnosis through 1-month post-surgery).
Intervention: exercise and nutritional prehabilitation (Behavioral)
Outcomes
Primary Outcomes
Completion Rate of 2-Week Prehabilitation Program
Time Frame: 2 weeks
Percentage of participants who successfully complete the 2-week prehabilitation program for head and neck cancer patients.
Participant Safety During the 2-Week Program
Time Frame: 2 weeks
Number of participants who experience adverse events during the 2-week prehabilitation program, assessed using CTCAE v5.0 criteria.
Acceptability of the Program
Time Frame: 2 weeks
Number of participants who rate the prehabilitation program as acceptable, using a 5-point Likert scale (1 = Not Acceptable, 5 = Very Acceptable).
Feasibility of the Program
Time Frame: 2 weeks
Percentage of planned exercise and nutrition activities completed by participants during the 2-week prehabilitation program.
Secondary Outcomes
No secondary outcomes reported
