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Behavioural Intervention
Resistance Training + Protein Supplementation for Pancreatic Cancer
N/A
Recruiting
Led By Christina M Dieli-Conwright, PhD, MPH
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Speak English or Spanish
Non-metastatic pancreatic cancer patients initiating neoadjuvant chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
Awards & highlights
Study Summary
This trial will test whether adding protein supplements to a resistance exercise program helps pancreatic cancer patients undergoing chemotherapy to maintain or improve their skeletal muscle mass.
Who is the study for?
This trial is for adults over 18 with non-metastatic pancreatic cancer starting chemotherapy. They must understand English or Spanish, be able to exercise (not currently doing moderate/vigorous activity over 60 minutes/week), not smoke, and can travel to DFCI for check-ups. Excluded are those with uncontrolled illnesses, other cancers, or conditions preventing exercise.Check my eligibility
What is being tested?
The RE-BUILD Trial tests if resistance training (RT) combined with protein supplements improves muscle mass in pancreatic cancer patients during chemo compared to RT alone or attention control (home-based stretching).See study design
What are the potential side effects?
While the study focuses on benefits rather than side effects, potential risks may include typical exercise-related issues like muscle soreness or strain from resistance training.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can communicate in English or Spanish.
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I am starting chemotherapy for my pancreatic cancer that has not spread.
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I am over 18 years old.
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I can start a supervised exercise program without health issues stopping me.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Exercise Session Attendance Rate
Protein Supplementation (PS) Rate
Secondary outcome measures
Gait Speed
Muscular Strength
Physical Fitness - Performance
+16 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Resistance Training (RT) and Protein Supplementation (PS)Experimental Treatment1 Intervention
Participants will be randomly assigned to the Resistance Training (RT) and Protein Supplementation (PS) group and receive virtually (Zoom) supervised home-based exercise program 3-days a week with daily protein supplementation for the duration of their chemotherapy with a maximum of 16-weeks of exercise. Exercises will be tailored to the participants' fitness levels.
Sessions will last ~60 minutes including 5-minute warm-up and 5-minute cool-down.
Participants will also have two body composition scans using CT over the span of chemotherapy treatment (maximum 16 weeks) and approximately 3 hours of evaluation of testing on 3 occasions.
Group II: Resistance Training (RT)Experimental Treatment1 Intervention
Participants will be randomly assigned to the Resistance Training (RT) group and receive virtually (Zoom) supervised home-based exercise program 3-days a week. Exercises will be tailored to the participants' fitness levels.
Participants will also have two body composition scans using CT over the span of chemotherapy treatment (maximum 16 weeks) and approximately 3 hours of evaluation of testing on 3 occasions.
Group III: Attention Control (AC)Active Control1 Intervention
Participants will be randomly assigned to the Attention Control (AC) group and receive instruction on a home-based, 3 days a week stretching program.
Participants will also have two body composition scans using CT over the span of chemotherapy treatment (maximum 16 weeks) and approximately 3 hours of evaluation of testing on 3 occasions.
The attention control group will be given the option to participate in the exercise intervention after their treatment is completed, with a cap of a 16-week period.
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,903 Total Patients Enrolled
Christina M Dieli-Conwright, PhD, MPHPrincipal InvestigatorDana-Farber Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any uncontrolled illnesses like infections or unmanaged diabetes, high blood pressure, or thyroid issues.I don't have any muscle, heart, lung, or nerve conditions that stop me from exercising.I cannot travel to the clinic for check-ups.I can communicate in English or Spanish.You do not engage in at least 60 minutes of moderate or vigorous exercise each week.My cancer has spread to other parts of my body.I am starting chemotherapy for my pancreatic cancer that has not spread.I will be getting other cancer treatments during the study.You do more than 60 minutes of structured exercise at a moderate or vigorous level each week.I am over 18 years old.I do not have any other active cancers.You are currently a smoker.I can start a supervised exercise program without health issues stopping me.You have not smoked at all in the past year.You are pregnant because we don't know how exercise might affect the growing baby.
Research Study Groups:
This trial has the following groups:- Group 1: Attention Control (AC)
- Group 2: Resistance Training (RT) and Protein Supplementation (PS)
- Group 3: Resistance Training (RT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has enrollment for this medical experiment opened to the public?
"Currently, clinicaltrials.gov indicates that this medical trial is not recruiting any participants at the moment. The initial posting for the study was on November 1st 2022 with its most recent edit occurring on April 29th 2022. Although there are no longer spots available in this particular research project, 700 other studies require volunteers to participate now."
Answered by AI
What results are researchers expecting to gain from this investigation?
"The primary objective of the clinical trial, evaluated between baseline and up to 16 weeks post-intervention, is to measure Protein Supplementation (PS) Rate. Secondary outcomes will include an analysis of plasma biomarkers such as IL-6, MCP-1, TNF-RII and branched chain amino acids; physical function assessment utilizing a 6 minute walk test through paired t tests or Wilcoxon signed rank tests; and functional power measurements using the Margaria Stair Climb Test with corresponding 95% exact CI calculations."
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