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

Dana-Farber Cancer Institute

Status: Enrolling

Conditions: Pancreatic Cancer

Treatments: Behavioral: Resistance Training (RT) and Protein Supplementation (PS); Behavioral: Attention Control (AC; Behavioral: Resistance Training (RT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05356117

21-506

Details and patient eligibility

About

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

Full description

This research study is a randomized controlled trial that will assess feasibility and compare skeletal muscle mass, biomarkers of tissue wasting, physical function, and overall quality of life between three groups - exercise and supplement, exercise-only, and attention control. This study intends to evaluate whether resistance exercise and protein supplementation can improve skeletal muscle mass as well as decrease tissue wasting biomarkers in the blood, among patients undergoing chemotherapy for pancreatic cancer as there is some evidence that pancreatic cancer patients can experience muscle wasting while on chemotherapy.

The research study procedures include: screening for eligibility and study treatment including extensive evaluations of participant fitness and body composition including CT, blood tests, fitness and strength assessments, and surveys at study entry, half-way through the intervention, and follow-up visit.

Participants in this study will be randomly assigned to one of three groups: 1) Resistance exercise and protein supplementation (RE+ PS), 2) Resistance exercise (RE), or 3) Attention control (AC).

This research study is expected to last for up to a total of 4 months.

It is expected that about 45 people will take part in this research study.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Resistance Training (RT) and Protein Supplementation (PS)

Experimental group

Description:

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.

Treatment:

Behavioral: Resistance Training (RT) and Protein Supplementation (PS)

Resistance Training (RT)

Experimental group

Description:

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.

Treatment:

Behavioral: Resistance Training (RT)

Attention Control (AC)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Attention Control (AC