Exercise and Nutrition to Improve Pancreatic Cancer Outcomes

NCT03256201 | Active Not Recruiting DMC

• 1 other identifier: 5991
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Cancer

Keywords

Cancer; prehabilitation; sarcopenia

Outcome Measures

Primary Outcomes (3)

• Accrual

  The percentage of eligible patients enrolled

  2 year

• Retention

  Retention as the percentage of enrolled patients retained assessment point

  2 year

• Adherence

  Adherence will be estimated as percentage of prescribed exercise completed based on exercise diaries and phone calls

  2 year

Secondary Outcomes (9)

• Quality of Life Assessment

  Approximately 1-3 days pre-op

• Change in Body Weight

  Approximately 1-3 days pre-op

• Change in Body Weight

  Approximately 1-3 days pre-op

• Physical Performance

  Approximately 1-3 days pre-op

• Physical Performance

  Approximately 2-4 weeks pre-op

Study Arms (2)

Standard Exercise Group

EXPERIMENTAL

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.

Behavioral: Nutritional Counseling; Behavioral: Standard Exercise

Enhanced Exercise Group

EXPERIMENTAL

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.

Behavioral: Nutritional Counseling; Behavioral: Enhanced Exercise

Interventions

Nutritional Counseling BEHAVIORAL

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.

Enhanced Exercise Group; Standard Exercise Group

Standard Exercise BEHAVIORAL

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.

Standard Exercise Group

Enhanced Exercise BEHAVIORAL

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.

Enhanced Exercise Group

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasms; Sarcopenia

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Elizabeth Hile, PhD, PT

  Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2017
• First Posted: August 21, 2017
• Study Start: February 1, 2016
• Primary Completion: April 1, 2024
• Study Completion: March 1, 2025
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)