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Preoperative Exercise in Pancreatic Cancer

NCT ID: NCT02648880

Last Updated: 2021-11-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-10

Study Completion Date

2021-01-31

Brief Summary

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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.

Detailed Description

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This study focuses on patients prescribed neoadjuvant (preoperative chemotherapy and radiation) prior to surgery for borderline resectable pancreatic adenocarcinoma. This allows for a known, preoperative window long enough to provide an effective exercise intervention. The exercise program will be administered for at least eight weeks, but has no cap on length, as neoadjuvent treatment periods can vary between participants and a cessation of the exercise program before the end of this period could result in an undesirable loss in physical fitness and function.

The study is a non-randomized, parallel group, intervention control trial, based on pilot studies in similar patient populations. All participants meeting the inclusion criteria and able to participate in the exercise program will be assigned to the exercise group. Participants meeting the inclusion criteria, but unable to commit to the exercise program for practical reasons (transportation, location, etc), will be assigned to the standard care group.

Conditions

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Pancreatic Cancer

Keywords

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Exercise Physical Activity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Exercise Group

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.

Group Type EXPERIMENTAL

Exercise program

Intervention Type 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.

Standard Care

Intervention Type 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.

Standard Care

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.

Group Type ACTIVE_COMPARATOR

Standard Care

Intervention Type 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.

Interventions

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Exercise program

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.

Intervention Type BEHAVIORAL

Standard Care

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Catherine Jankowski, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Anschutz Health and Wellness Center

Aurora, Colorado, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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15-2266.cc

Identifier Type: -

Identifier Source: org_study_id