Exercise and Nutritional Prehabilitation for Head and Neck Cancer Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer; Sarcopenia; Head Cancer; Neck Cancer
• Intervention / Treatment: Behavioral: exercise and nutritional prehabilitation

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.

Subjects will otherwise also have their usual post-operative and post-discharge care with their provider and have their final study-related visit approximately 1 month after surgery.

Primary end-point will be to assess the feasibility, acceptability, and safety of this program.2,3

- Safety will be monitored throughout the study period, including during the prehabilitation period with a study member calling the patient weekly (Day 7 and Day 14 or prehabilitation).

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Randev Sandhu CRC Supervisor, BS; Phone Number: 9167342863; Email: rssandhu@ucdavis.edu
• Study Contact Backup: Name: Marianne Abouyared PI, MD; Phone Number: 9167342801; Email: mabouyared@ucdavis.edu

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • Recruiting
      • UC Davis Medical Center
      • Contact: Marianne Abouyared PI, MD; Phone Number: 9167342801; Email: mabouyared@ucdavis.edu
      • Contact: Randev Sandhu CRC Supervisor, BS; Phone Number: 916-734-2863; Email: rssandhu@ucdavis.edu
      • Principal Investigator: Marianne Abouyared PI, MD
    • Sacramento, California, United States, 95817
      • Recruiting
      • UC Davis Health
      • Contact: Marianne Abouyared, MD; Phone Number: 916-734-2704; Email: mabouyared@ucdavis.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

New head and neck cancer diagnosis Age > 18

Exclusion Criteria:

1. Prior treatment for head and neck cancer (surgery and/or radiation)
2. Acute or unstable cardiac conditions (unstable angina or symptomatic severe aortic stenosis)
3. American Society of Anesthesiologists physical status of 4 and 5
4. Disabling orthopedic or neuromuscular disease
5. Cardiac failure (New York Heart Association functional classes III and IV)
6. Severe chronic obstructive pulmonary disease
7. End-stage liver or kidney disease
8. Inability to swallow and/or feeding tube dependence
9. Any other comorbid medical, physical, and/or mental condition that contraindicates exercise or oral nutrition
10. Adults unable to consent
11. Age 17.99 or younger
12. Prisoners, pregnant women, or other vulnerable population

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Behavioral: exercise and nutritional prehabilitation; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion Rate of 2-Week Prehabilitation Program	Percentage of participants who successfully complete the 2-week prehabilitation program for head and neck cancer patients.	2 weeks
Participant Safety During the 2-Week Program	Number of participants who experience adverse events during the 2-week prehabilitation program, assessed using CTCAE v5.0 criteria.	2 weeks
Acceptability of the Program	Number of participants who rate the prehabilitation program as acceptable, using a 5-point Likert scale (1 = Not Acceptable, 5 = Very Acceptable).	2 weeks
Feasibility of the Program	Percentage of planned exercise and nutrition activities completed by participants during the 2-week prehabilitation program.	2 weeks

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Marianne S Abouyared, MD, University of California, Davis

Publications and helpful links

General Publications

• Knols R, Aaronson NK, Uebelhart D, Fransen J, Aufdemkampe G. Physical exercise in cancer patients during and after medical treatment: a systematic review of randomized and controlled clinical trials. J Clin Oncol. 2005 Jun 1;23(16):3830-42. doi: 10.1200/JCO.2005.02.148.
• Powell R, Davies A, Rowlinson-Groves K, French DP, Moore J, Merchant Z. Acceptability of prehabilitation for cancer surgery: a multi-perspective qualitative investigation of patient and 'clinician' experiences. BMC Cancer. 2023 Aug 11;23(1):744. doi: 10.1186/s12885-023-10986-0.

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 19, 2024
• First Submitted That Met QC Criteria: December 5, 2024
• First Posted (Actual): December 9, 2024

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Exercise; Cancer; Head; Prehabilitation; Neck; Nutritional
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Neoplasms by Site; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Neoplasms; Head and Neck Neoplasms; Sarcopenia; Motor Activity; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: 2072911

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No