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Exercise and Nutrition to Improve Pancreatic Outcomes

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ClinicalTrials.gov Identifier: NCT03256201
Recruitment Status : Recruiting
First Posted : August 21, 2017
Last Update Posted : May 22, 2020
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma

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, either with or without individualized resistance training in order to determine if resistance improves outcomes.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Behavioral: Nutritional Counseling Behavioral: Standard Exercise Behavioral: Enhanced Exercise Not Applicable

Detailed Description:

This initial 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, but return to exercise in the post-operative period is collected by self-report.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Preoperative Exercise and Nutrition to Improve Pancreatic Cancer Outcomes by Targeting Sarcopenia: A Translational Pilot RCT
Actual Study Start Date : February 1, 2016
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Standard Exercise Group
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
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. For the last 5 days, all participants switch to Impact Advanced Recovery® (provided), as standard care at our facility.

Behavioral: 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.

Experimental: Enhanced Exercise Group
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
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. For the last 5 days, all participants switch to Impact Advanced Recovery® (provided), as standard care at our facility.

Behavioral: 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.




Primary Outcome Measures :
  1. Quality of Life Assessment [ Time Frame: Approximately 4 weeks post-op ]
    Quality of life will be assessed using Functional Assessment of Cancer Therapy General Scale (FACT-G) at first post -operative visit


Secondary Outcome Measures :
  1. Quality of Life Assessment [ Time Frame: Approximately 4 months post-op ]
    Quality of Life as the functional Assessment of Cancer Therapy General (FACT-G) Scale at second post-op visit

  2. Change in Body Weight [ Time Frame: Approximately 4 weeks post-op ]
    Change in baseline body weight in pounds at first post operative visit

  3. Change in Body Weight [ Time Frame: Approximately 4 months post-op ]
    Change in baseline body weight in pounds at second post operative visit

  4. Change in Body Weight [ Time Frame: Approximately 4 weeks post-op ]
    Change in baseline body lean mass and fat mass in pounds at first post-op visit

  5. Change in Body Weight [ Time Frame: Approximately 4 months post-op ]
    Change in baseline body lean mass and fat mass in pounds at second post-operative visit

  6. Physical Performance [ Time Frame: Approximately 4 months post-op ]
    Six-Minute Walk Test in meters at second post-operative visit. The Six Minute Walk test will be performed according to American Thoracic Society Guidelines.

  7. Physical Performance [ Time Frame: Approximately 4 months post-op ]
    An expanded Short Physical Performance Battery at second post-op visit

  8. Assessment of Fatigue [ Time Frame: Approximately 4 weeks post-op ]
    MD Anderson Brief Fatigue Inventory (BFI) Severity and Interference Scores, at first post-operative visit.

  9. Assessment of Symptoms [ Time Frame: Approximately 4 weeks post-op ]
    Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep), at first post-operative visit.

  10. Assessment of Symptoms [ Time Frame: Approximately 4 weeks post-op ]
    Functional Assessment of Cancer Therapy- Hepatobiliary (FACT-Hep), at first post-operative visit.

  11. Assessment of Symptoms [ Time Frame: Approximately 4 weeks post-op ]
    Functional Assessment of Anorexia-Cachexia Therapy - FAACT, at first post-operative visit.

  12. Assessment of Symptoms [ Time Frame: Approximately 4 months post-op ]
    Functional Assessment of Anorexia-Cachexia Therapy - FAACT, at second post-operative visit.

  13. Quality of Life Assessment [ Time Frame: Approximately 4 weeks post-op ]
    Basic and Instrumental Activities of Daily Living (number of activities rated as difficult or requiring assistance), at first post-operative visit.

  14. Quality of Life Assessment [ Time Frame: Approximately 4 months post-op ]
    Basic and Instrumental Activities of Daily Living (number of activities rated as difficult or requiring assistance), at first post-operative visit.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03256201


Contacts
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Contact: Ingrid Block, RN 405 271-8777 ingrid-block@ouhsc.edu

Locations
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United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Ingrid Block, RN    405-271-8777    ingrid-block@ouhsc.edu   
Contact: Andrea Andrews, BA    405 271-8777    andrea-andrews@ouhsc.edu   
Sponsors and Collaborators
University of Oklahoma
Investigators
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Principal Investigator: Elizabeth Hile, PhD, PT Faculty
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Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT03256201    
Other Study ID Numbers: 5991
First Posted: August 21, 2017    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Oklahoma:
Cancer
prehabilitation
sarcopenia
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases