RECRUITING

Resistance Exercise Combined With Protein Supplementation in People With Pancreatic Cancer: The RE-BUILD Trial

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Resistance Exercise Combined With Protein Supplementation for Skeletal Muscle Mass in People With Pancreatic Cancer Undergoing Chemotherapy: The RE-BUILD Trial

Quick Facts

Study Start:2022-09-01

Study Completion:2025-08-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05356117

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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 of the investigator, may not be able to comply with the safety monitoring requirements of the study. * Is unable to travel to DFCI for assessments. * Patients who are pregnant due to the unknown effects of exercise on the developing fetus.

Inclusion Criteria

Exclusion 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.

* 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 of the investigator, may not be able to comply with the safety monitoring requirements of the study.
* Is unable to travel to DFCI for assessments.
* Patients who are pregnant due to the unknown effects of exercise on the developing fetus.

Contacts and Locations

Study Contact

Christina M Dieli-Conwright, PhD, MPH

CONTACT

617-582-8321

ChristinaM_Dieli-Conwright@dfci.harvard.edu

Christina M Dieli-Conwright, PhD, MPH

CONTACT

Principal Investigator

Christina M Dieli-Conwright, PhD, MPH

PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Study Locations (Sites)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

Christina M Dieli-Conwright, PhD, MPH, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-01

Study Completion Date2025-08-15

Study Record Updates

Study Start Date2022-09-01

Study Completion Date2025-08-15

Terms related to this study

Keywords Provided by Researchers

Pancreatic Cancer

Additional Relevant MeSH Terms

Pancreatic Cancer