Exercise and Nutritional Prehabilitation for Head and Neck Cancer Patients
NCT ID: NCT06722508
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-05-09
2025-12-31
Brief Summary
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Detailed Description
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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).
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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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).
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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University of California, Davis
OTHER
Responsible Party
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Mariane Abouyared
Associate Professor
Principal Investigators
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Marianne S Abouyared, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Davis
Locations
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UC Davis Health
Sacramento, California, United States
UC Davis Medical Center
Sacramento, California, United States
Countries
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Central Contacts
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Facility Contacts
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Marianne Abouyared, MD
Role: primary
Randev Sandhu CRC Supervisor, BS
Role: primary
Marianne Abouyared PI, MD
Role: backup
References
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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.
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.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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2072911
Identifier Type: -
Identifier Source: org_study_id