Exercise and Nutritional Prehabilitation for Head and Neck Cancer Patients

NCT06722508 | Recruiting

• 1 other identifier: 2072911
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Head Cancer; Neck Cancer; Sarcopenia; Head and Neck Cancer

Keywords

Exercise; Nutritional; Prehabilitation; Head; Neck; Cancer

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

behavioral intervention

EXPERIMENTAL

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

Interventions

exercise and nutritional prehabilitation BEHAVIORAL

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 intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• New head and neck cancer diagnosis Age \> 18

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (2)

UC Davis Health

Sacramento, California, 95817, United States

RECRUITING

UC Davis Medical Center

Sacramento, California, 95817, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 37568097 BACKGROUND

• 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.

  PMID: 15923576 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms; Sarcopenia; Motor Activity; Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Marianne S Abouyared, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Randev Sandhu CRC Supervisor, BS

CONTACT

9167342863; rssandhu@ucdavis.edu

Marianne Abouyared PI, MD

CONTACT

9167342801; mabouyared@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: December 9, 2024
• Study Start: May 9, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)