Preoperative Exercise in Pancreatic Cancer

NCT02648880 | Completed Results

• 1 other identifier: 15-2266.cc
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effects of a preoperative exercise program in patients with pancreatic cancer preparing for surgery. Preoperative exercise programs have been shown to be effective in other cancer populations, but have not been investigated in patients with pancreatic cancer. The outcomes in this study will be changes in physical fitness, function, and postoperative outcomes. This investigation is a non-randomized control trial, with participants assigned to receive the preoperative exercise intervention in addition to standard care, or standard care alone if unable to commit to an exercise program for practical reasons. Possible mediators for the effects of exercise on postoperative outcomes will also be assessed, including psychological outcomes and markers of systemic inflammation. These measures will be assessed in all participants prior to program initiation, prior to surgery, and after surgery. Changes in these measures in response to exercise will be assessed, as well as the ability of the preoperative measures to predict postoperative outcomes.

Conditions

Pancreatic Cancer

Keywords

Exercise; Physical Activity

Outcome Measures

Primary Outcomes (1)

• Change in 400-meter Walk Time

  Assessment of physical fitness and function. Participants are timed while walking 400 meters at a fast, but safe, pace.

  Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative

Secondary Outcomes (23)

• Change in Body Composition

  Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative

• Change in Gait Speed

  Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative

• Change in Timed Up and Go

  Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative

• Change in Stair Climb Test

  Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative

• Change in Single Limb Stance

  Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative

Study Arms (2)

Exercise Group

EXPERIMENTAL

Participants will complete an exercise program in addition to standard care. Participants will start the exercise program within four weeks of their diagnosis and decision to undergo neoadjuvant treatment and continue until surgery. Participants will be encouraged to complete three sessions per week for at least eight weeks during neoadjuvant therapy. Exercise intensity, components, and time will be recorded for each exercise session. Participants will schedule their sessions with the exercise specialists administering the program, typically taking place between 8AM and 4PM, Monday through Friday.

Behavioral: Exercise program; Other: Standard Care

Standard Care

ACTIVE COMPARATOR

Participants in the Standard Care group will receive no exercise intervention, but will continue to receive standard follow-ups, treatments and services from their oncology team.

Other: Standard Care

Interventions

Exercise program BEHAVIORAL

Individual exercise sessions in this program implement a "whole body" approach and consist of a 10-min cardiovascular warm-up and 50 minutes of cardiovascular endurance, resistance, and flexibility exercises. Target intensity of exercise will be based on the American College of Sports Medicine recommendations for cancer survivors. Prior to the start of exercise sessions, participants will be questioned on significant changes in symptoms or the presence of new symptoms (such as nausea or fever), which will used to modify the exercise session for that day to allow maximum symptom-limited participation.

Exercise Group

Standard Care OTHER

The services that participants receive as standard care include their medical care, symptom control, social worker support, and nutrition. These services are provided by their oncology team.

Exercise Group; Standard Care

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recent (\< 4 week) first diagnosis of a borderline resectable pancreatic adenocarcinoma
• Prescription to receive neoadjuvant therapy and surgery,
• Age 21 to 80 years old,
• Physician clearance to participate in exercise program.

You may not qualify if:

• Any significant comorbid conditions that would interfere with or preclude participation in an exercise intervention, including orthopedic conditions such as advanced osteoarthritis, mobility-limiting amputations or chronic injuries, or mobility-limiting acute orthopedic injuries
• Advanced rheumatoid arthritis
• Widespread chronic pain conditions such as fibromyalgia
• Pulmonary conditions such as chronic obstructive pulmonary disease, emphysema, interstitial lung disease, use of supplementary oxygen
• Known cardiovascular disease or new cardiac event in last 6 months
• Diabetes
• Pregnancy
• Second cancer diagnosis at the time of enrollment

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Health and Wellness Center

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Motor Activity

Interventions

Resistance Training; Standard of Care

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Ryan Marker
• Organization: University of Colorado

ryan.marker@cuanschutz.edu

3037240819

Study Officials

• Catherine Jankowski, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2015
• First Posted: January 7, 2016
• Study Start: May 10, 2016
• Primary Completion: January 20, 2017
• Study Completion: January 1, 2021
• Last Updated: November 30, 2021
• Results First Posted: November 30, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)