Resistance Exercise Combined With Protein Supplementation in People With Pancreatic Cancer: The R… (NCT05356117) | Clinical Trial Compass
RecruitingNot Applicable
Resistance Exercise Combined With Protein Supplementation in People With Pancreatic Cancer: The RE-BUILD Trial
United States45 participantsStarted 2022-09-01
Plain-language summary
The purpose of this research is to determine whether a virtually supervised resistance exercise (RE) intervention combined with protein supplementation (PS) is feasible in pancreatic cancer patients initiating chemotherapy and if it will improve skeletal muscle mass.
The names of the study interventions involved in this study are:
* Resistance training and protein supplement intake (RE + PS)
* Resistance training (RE)
* Attention control (AC), home-based stretching
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Non-metastatic pancreatic cancer patients initiating neoadjuvant chemotherapy.
* Ability to understand and the willingness to sign a written informed consent document.
* Over the age of 18 years; children under the age of 18 will be excluded due to rarity of disease.
* Speak English or Spanish.
* Able to provide physician clearance to participate in the exercise program.
* Able to initiate a supervised exercise program (free from any cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity).
* Currently participate in less than or equal to 60 minutes of structured moderate or vigorous exercise/week.
* Does not smoke (no smoking during previous 12 months).
* Willing to travel to DFCI for assessments.
Exclusion Criteria:
* Patients should not have any uncontrolled illness including ongoing or active infection, uncontrolled diabetes, hypertension or thyroid disease.
* Patients may not be receiving any other investigational agents.
* Patients with other active malignancies are ineligible for this study.
* Patients with metastatic disease.
* History of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise.
* Patients expected to receive other cancer directed treatments during the study and assessment period.
* Participates in more than 60 minutes of structured moderate or vigorous exercise/week.
* Currently smokes.
* Subjects, who in the opinion o…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Exercise Session Attendance Rate
Timeframe: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
2
Protein Supplementation (PS) Rate
Timeframe: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)