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Preoperative Rehabilitation During Neoadjuvant Therapy for Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Questionnaires
Exercise
Nutrition Counseling
Phone Calls
Booklet
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pancreatic Cancer focused on measuring Pancreatic Cancer, Pancreatic adenocarcinoma, Preoperative therapy, Questionnaires, Surveys, Exercises, Stretching, Walking, Nutrition counseling, Resistance exercise bands, Phone calls, Booklet, Pamphlet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Pancreatic adenocarcinoma, biopsy-proven or suspected.
  2. Scheduled for intended pancreatectomy, > 4 weeks until planned resection.
  3. Scheduled for neoadjuvant chemotherapy and/or chemoradiation for pancreatic cancer.
  4. Able to understand the description of the study and willing to participate.
  5. Able to understand the exercise intervention and able to maintain a daily exercise log.
  6. Participant must have telephone access and agree to engage with telephone access with the research personnel.

Exclusion Criteria:

  1. Non-English speaking.
  2. Unable to complete the baseline assessment questionnaires or functional assessments.
  3. Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV).
  4. Recent fracture or acute musculoskeletal injury that precludes the ability to weight bear fully on all 4 limbs in order to participate in an exercise intervention.
  5. Numeric pain rating scale of >/= 7 out of 10.
  6. Myopathic or rheumatologic disease that impacts physical function.

Sites / Locations

  • University of Houston
  • University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Home Based Exercise and Nutrition Program

Arm Description

Series of physical and quality of life assessments administered to participants, taking about 20 minutes to complete. Participants instructed to perform resistance/strengthening exercises for 30 minutes two times each week. Exercise instructional booklet given to all participants describing all exercises. Participants to walk 20-30 minutes at least 3 times a week. Nutrition program discussed with participants. Participants receive phone calls from study staff every 2 weeks for 6 weeks to check for adherence, and if they are having any side effects from the exercise.

Outcomes

Primary Outcome Measures

Feasibility of Prehabilitation Program Among Pancreatic Patients
Feasibility established if > 60% of patients are adherent. Prehabilitation program deemed feasible if 60% or more of participants complete at least 60% of the weekly 150-minute combined walking and strengthening exercises during the 6-week preoperative period.

Secondary Outcome Measures

Full Information

First Posted
November 18, 2014
Last Updated
June 10, 2019
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02295956
Brief Title
Preoperative Rehabilitation During Neoadjuvant Therapy for Pancreatic Cancer
Official Title
Preoperative Rehabilitation During Neoadjuvant Therapy for Pancreatic Cancer: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
February 2, 2015 (Actual)
Primary Completion Date
June 6, 2019 (Actual)
Study Completion Date
June 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this research study is to learn if it is possible to start a home-based exercise and nutrition program for patients with pancreatic cancer or who may have pancreatic cancer before surgery (pre-operative rehabilitation, also known as prehabilitation).
Detailed Description
Study Procedures: If you are found to be eligible to take part in this study, you will be asked to complete additional questionnaires about your physical activity and quality of life. It will take about 20 minutes to complete all of the questionnaires in this study. Your strength and walking speed will also be checked using a hand-held grip test, having you stand from a sitting position five times, and a 6 minute walking test. The exercise regimen will then be discussed with you. It will include a resistance/ strengthening program and a walking program. You will receive a booklet and an instructional video describing all of the exercises, a set of resistance tubes and accessories you need to perform all exercises, and a pedometer to count your daily steps. Also, a specialist in rehabilitation along with other study staff will teach you the stretching and strengthening exercises. An MD Anderson rehabilitation doctor will oversee all of this. Resistance/Strengthening Program: You will be instructed to perform resistance/strengthening exercises for 30 minutes at least two times each week. The exercises used in this study are designed to strengthen your muscles. Strengthening certain muscle groups will help with upper body control and balance, which the study staff believes may help with mobility before and after surgery. Also, strengthening the shoulder, back, and leg muscles are important for activities such as getting into and out of bed, which is important after surgeries such as pancreas surgery. You will be instructed to perform any 8 (out of 19) strengthening exercises for a total of 30 minutes. You will be issued a set of 3 resistance exercise tubes with which the exercises can be performed. The strengthening exercises consist of seated and standing weight-bearing exercises. You will perform 3 sets of 8-12 repetitions each of each exercise. When you are able to perform 3 sets of 12 repetitions of an exercise, you will move up to the next level of resistance (different color tube). Before the strengthening exercises, you will do a series of 4 standing warm-up exercises that will help with balance. You will record the date, resistance (color of resistance tube used), number of repetitions and sets, and how hard a session of resistance exercises felt for you. You will also record the total time spent on the strengthening program after each exercise session You will be encouraged to complete an additional 5 minutes of stretching following the exercises. You will be provided with a handout demonstrating upper body, back, and leg stretches to help prevent soreness. Walking Program: The walking program will consist of walking briskly for 20-30 minutes at least 3 times each week. If you are unable to tolerate walking at a brisk speed, you will be instructed to walk at a slower pace. You will be given a pedometer and will be instructed to record the number of steps taken each day in addition to the total time spent during each walking session. Nutrition: Within 7 days after being enrolled on this study, you will meet with a dietitian to discuss your nutrition. You will be then be provided with recommendations for calorie, protein, and fluid intake, tools for tracking intake (such as a diet log), as well as goals for weight depending on your treatment/recovery. You will also be instructed to eat a high protein snack/meal/shake within 1 hour after each strengthening session. Phone Calls: You will be called every 2 weeks and asked if you are following the exercise and nutrition programs and if you are having any side effects from the exercise (such as pain or difficulty breathing). You will also be asked which resistance band you are using. Each phone call will take about 10-15 minutes. Length of Study: You will use the exercise programs during your entire pre-operative period, including during the time you are on other treatments before surgery. In addition, you will continue the exercise program and evaluations for up to 4 months after you have had surgery. If you have a side effect or the disease gets worse, the study staff will decide if continuing the exercise program is in your best interest. This is an investigational study. Up to 70 participants will be enrolled on this study. All will take part at MD Anderson.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Pancreatic Cancer, Pancreatic adenocarcinoma, Preoperative therapy, Questionnaires, Surveys, Exercises, Stretching, Walking, Nutrition counseling, Resistance exercise bands, Phone calls, Booklet, Pamphlet

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Home Based Exercise and Nutrition Program
Arm Type
Experimental
Arm Description
Series of physical and quality of life assessments administered to participants, taking about 20 minutes to complete. Participants instructed to perform resistance/strengthening exercises for 30 minutes two times each week. Exercise instructional booklet given to all participants describing all exercises. Participants to walk 20-30 minutes at least 3 times a week. Nutrition program discussed with participants. Participants receive phone calls from study staff every 2 weeks for 6 weeks to check for adherence, and if they are having any side effects from the exercise.
Intervention Type
Behavioral
Intervention Name(s)
Questionnaires
Other Intervention Name(s)
Surveys
Intervention Description
Series of physical and quality of life assessments administered to participants, taking about 20 minutes to complete.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Participants instructed to perform resistance/strengthening exercises for 30 minutes two times each week. Participants to walk 20-30 minutes at least 3 times a week. Participants issued a set of 3 resistance exercise bands with which the exercises can be performed.
Intervention Type
Other
Intervention Name(s)
Nutrition Counseling
Intervention Description
Within 7 days after being enrolled on study, participant meets with a dietitian to discuss nutrition.
Intervention Type
Behavioral
Intervention Name(s)
Phone Calls
Intervention Description
Participants receive phone calls from study staff every 2 weeks for 6 weeks to check for adherence, and if they are having any side effects from the exercise.
Intervention Type
Other
Intervention Name(s)
Booklet
Other Intervention Name(s)
Pamphlet
Intervention Description
Exercise instructional booklet given to all participants describing all exercises.
Primary Outcome Measure Information:
Title
Feasibility of Prehabilitation Program Among Pancreatic Patients
Description
Feasibility established if > 60% of patients are adherent. Prehabilitation program deemed feasible if 60% or more of participants complete at least 60% of the weekly 150-minute combined walking and strengthening exercises during the 6-week preoperative period.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pancreatic adenocarcinoma, biopsy-proven or suspected. Scheduled for intended pancreatectomy, > 4 weeks until planned resection. Scheduled for neoadjuvant chemotherapy and/or chemoradiation for pancreatic cancer. Able to understand the description of the study and willing to participate. Able to understand the exercise intervention and able to maintain a daily exercise log. Participant must have telephone access and agree to engage with telephone access with the research personnel. Exclusion Criteria: Non-English speaking. Unable to complete the baseline assessment questionnaires or functional assessments. Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV). Recent fracture or acute musculoskeletal injury that precludes the ability to weight bear fully on all 4 limbs in order to participate in an exercise intervention. Numeric pain rating scale of >/= 7 out of 10. Myopathic or rheumatologic disease that impacts physical function.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew H. Katz, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35660135
Citation
Kurz E, Hirsch CA, Dalton T, Shadaloey SA, Khodadadi-Jamayran A, Miller G, Pareek S, Rajaei H, Mohindroo C, Baydogan S, Ngo-Huang A, Parker N, Katz MHG, Petzel M, Vucic E, McAllister F, Schadler K, Winograd R, Bar-Sagi D. Exercise-induced engagement of the IL-15/IL-15Ralpha axis promotes anti-tumor immunity in pancreatic cancer. Cancer Cell. 2022 Jul 11;40(7):720-737.e5. doi: 10.1016/j.ccell.2022.05.006. Epub 2022 Jun 2.
Results Reference
derived
PubMed Identifier
31858837
Citation
Ngo-Huang A, Parker NH, Bruera E, Lee RE, Simpson R, O'Connor DP, Petzel MQB, Fontillas RC, Schadler K, Xiao L, Wang X, Fogelman D, Sahai SK, Lee JE, Basen-Engquist K, Katz MHG. Home-Based Exercise Prehabilitation During Preoperative Treatment for Pancreatic Cancer Is Associated With Improvement in Physical Function and Quality of Life. Integr Cancer Ther. 2019 Jan-Dec;18:1534735419894061. doi: 10.1177/1534735419894061.
Results Reference
derived
PubMed Identifier
31592772
Citation
Parker NH, Lee RE, O'Connor DP, Ngo-Huang A, Petzel MQB, Schadler K, Wang X, Xiao L, Fogelman D, Simpson R, Fleming JB, Lee JE, Tzeng CD, Sahai SK, Basen-Engquist K, Katz MHG. Supports and Barriers to Home-Based Physical Activity During Preoperative Treatment of Pancreatic Cancer: A Mixed-Methods Study. J Phys Act Health. 2019 Dec 1;16(12):1113-1122. doi: 10.1123/jpah.2019-0027. Epub 2019 Oct 7.
Results Reference
derived
Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website

Learn more about this trial

Preoperative Rehabilitation During Neoadjuvant Therapy for Pancreatic Cancer

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