Clinical trial NCT06722508: Exercise and Nutritional Prehabilitation for Head and Neck Cancer Patients
Official title: Exercise and Nutritional Prehabilitation for Head and Neck Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head Cancer
Neck Cancer
Sarcopenia
Head and Neck Cancer
Keywords: Exercise
Nutritional
Prehabilitation
Head
Neck
Cancer
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Completion Rate of 2-Week Prehabilitation Program
timeFrame: 2 weeks
measure: Participant Safety During the 2-Week Program
timeFrame: 2 weeks
measure: Acceptability of the Program
timeFrame: 2 weeks
measure: Feasibility of the Program
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Health
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Marianne S Abouyared, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.