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Recruiting NCT05356117

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

No phase Interventional Pancreatic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Resistance Training (RT) and Protein Supplementation (PS), Resistance Training (RT), Attention Control (AC.
Who it may be relevant to
Registry conditions: Pancreatic Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed 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.

Interventions

  • Behavioral Resistance Training (RT) and Protein Supplementation (PS)
    Aerobic and resistance exercise with orally consumed pre-packed protein supplement
  • Behavioral Resistance Training (RT)
    Aerobic and resistance exercise
  • Behavioral Attention Control (AC
    Stretching

Primary outcome measures

  • Exercise Session Attendance Rate [Time frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)]
  • Protein Supplementation (PS) Rate [Time frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)]
Secondary outcome measures (12)
  • Skeletal Muscle Mass Change [Time frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)]
  • Tissue Wasting Biomarker Change [Time frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)]
  • Physical function - Margaria Stair Climb [Time frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)]
  • Muscular Strength [Time frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)]
  • Physical Fitness - Performance [Time frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)]
  • Physical Fitness - Sit to Stand [Time frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)]
  • Gait Speed [Time frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)]
  • Physical Function - Handgrip Strength [Time frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)]
  • Physical Function - 6 minute walk test [Time frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)]
  • Psychosocial function - Fatigue [Time frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)]
  • Psychosocial function - Quality of Life [Time frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)]
  • Psychosocial function - Depression [Time frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Screening

Study locations

United States · 1 center
  • Dana Farber Cancer Institute — Boston

Identifiers

NCT: NCT05356117 · 21-506

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗