Exercise and Nutrition to Improve Pancreatic Cancer Outcomes

Pancreatic Cancer Clinical Trial

Official title:

Preoperative Exercise and Nutrition to Improve Pancreatic Cancer Outcomes by Targeting Sarcopenia: A Translational Pilot RCT

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03256201
• Other study ID #: 5991
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2016
• Est. completion date: August 30, 2024

Study information

• Verified date: May 2024
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a blinded pilot study in which patients scheduled for pancreaticoduodenectomy for pancreatic or related cancers are randomized to dietary counseling and home exercise at high weekly frequency, either with or without individualized resistance training, in order to determine if such an intervention and research design are feasible in this population. We also aim to determine if physical function or quality of life can be improved with only 2-3 weeks of prehabilitation. This is in preparation for a larger study to determine if resistance improves outcomes.

Description:

This initial feasibility and proof of concept study focuses on maximizing pancreatic cancer survivors' fitness and physical function in a brief period, the 2-3 weeks available prior to surgical resection, using a home-based exercise program with all equipment provided, and following nutritional recommendations. Intervention begins when the oncologist determines that the patient is a candidate for pancreaticoduodenectomy, and continues until surgery. Participants in both arms are asked to perform moderate exercise daily, targeting a total of 60 minutes per day by the surgery date, but in bouts as short as a few minutes each, and progressed according to tolerance. Initial prescription is individualized according to the patient's baseline level of exercise and functional status. Patients record their exercise and wear an accelerometer to track activity if willing. All participants receive follow-up phone calls from an exercise specialist for adherence and assistance with progression. The intervention period ends at the time of surgery.

In this 'quasi-double blinded' randomized trial, participants are not told the difference between the two exercise interventions, and randomization to the two treatment arms is stratified by baseline functional status, such that patients deemed to be 'borderline' in fitness for surgery are distributed across the groups. Prior chemotherapy exposure is allowed and recorded.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 95
• Est. completion date: August 30, 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

Inclusion:

• Individuals with suspected pancreatic or related tumor for surgical resection by pancreaticoduodenectomy, including those who've received neoadjuvant chemotherapy, are eligible provided they are approved for exercise participation by pancreatic clinic team.

• Cognition and English language skills must be sufficient for completion of consent and questionnaires.

• Age >30.

• Able to rise from a chair and walk household distances without assist from another person.

• Willing to be randomized to one of two pre-operative home-based exercise programs, without knowing the difference between the two, and use protein supplementation if instructed.

Exclusion:

• Individuals are excluded if they are unsafe (according to the study team) based on current MD recommendation not to exercise, medical history, recent fracture or high-risk bone lesion, or neurologic disorder with safety concerns.

• Participants cannot have an allergy to whey protein, or abnormal response to baseline physical performance tests of walking endurance and strength.

• Those who currently participate in a regular and substantial (as defined by the study team) strengthening or protein supplementation program are eligible only for the 'for assessment only' observational version of the study, but will not be included in the randomized trial.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Behavioral:
• Nutritional Counseling
Patients in both arms receive a single counseling session with a licensed dietician to determine individual protein goal for body weight and current dietary intake. Goal is then met through protein supplementation (provided) if needed beyond dietary intake.
• Standard Exercise
Patients receive a single instruction session with a physical therapist, for training in moderate intensity (using Rate of Perceived Exertion) exercise including cardiovascular endurance, flexibility, and AROM of upper and lower body. If no other preferred mode of endurance training, a home ergometer is provided for use with arms and/or legs.
• Enhanced Exercise
Patients receive a single instruction session with a physical therapist, for training in moderate intensity (using Rate of Perceived Exertion) exercise including cardiovascular endurance, flexibility, and resistance exercise for upper and lower body. If no other preferred mode of endurance training, a home ergometer is provided for use with arms and/or legs.

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accrual	The percentage of eligible patients enrolled	2 year
Primary	Retention	Retention as the percentage of enrolled patients retained assessment point	2 year
Primary	Adherence	Adherence will be estimated as percentage of prescribed exercise completed based on exercise diaries and phone calls	2 year
Secondary	Quality of Life Assessment	Quality of life will be assessed using Functional Assessment of Cancer Therapy General Scale (FACT-G) during the pre-operative period (V1-V2). Scale is 0-108. The higher the score, the better the score.	Approximately 1-3 days pre-op
Secondary	Change in Body Weight	Change in baseline body weight in pounds during the pre-operative period (V1-V2)	Approximately 1-3 days pre-op
Secondary	Change in Body Weight	Change in baseline body weight in pounds at second post operative visit	Approximately 1-3 days pre-op
Secondary	Physical Performance	Six-Minute Walk Test in meters during the pre-operative period (V1-V2). The Six Minute Walk test will be performed according to American Thoracic Society Guidelines.	Approximately 1-3 days pre-op
Secondary	Physical Performance	Gait Speed at usual pace	Approximately 2-4 weeks pre-op
Secondary	Physical Performance	Grip Strength . with a Jamar handgrip dynamometer .	Approximately 1-3 days pre-op
Secondary	Physical Performance	Sit-to-Stand .Time to 5th Stand will be performed according to the Short Performance Physical Battery.	Approximately 4 months post-op
Secondary	Assessment of Symptoms	Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep), at first post-operative visit.	Approximately 4 weeks post-op
Secondary	Assessment of Symptoms	Functional Assessment of Anorexia-Cachexia Therapy - FAACT, during the pre-operative period (V1-V2).	Approximately 1-3 days pre-op