Clinical trial NCT05356117: Resistance Exercise Combined With Protein Supplementation in People With Pancreatic Cancer: The RE-BUILD Trial
Official title: Resistance Exercise Combined With Protein Supplementation for Skeletal Muscle Mass in People With Pancreatic Cancer Undergoing Chemotherapy: The RE-BUILD Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatic Cancer
Keywords: Pancreatic Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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

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.

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.

Primary outcomes:
measure: Exercise Session Attendance Rate
timeFrame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
measure: Protein Supplementation (PS) Rate
timeFrame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
Secondary outcomes:
measure: Skeletal Muscle Mass Change
timeFrame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
measure: Tissue Wasting Biomarker Change
timeFrame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
measure: Physical function - Margaria Stair Climb
timeFrame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
measure: Muscular Strength
timeFrame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
measure: Physical Fitness - Performance
timeFrame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
measure: Physical Fitness - Sit to Stand
timeFrame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
measure: Gait Speed
timeFrame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
measure: Physical Function - Handgrip Strength
timeFrame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
measure: Physical Function - 6 minute walk test
timeFrame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
measure: Psychosocial function - Fatigue
timeFrame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
measure: Psychosocial function - Quality of Life
timeFrame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
measure: Psychosocial function - Depression
timeFrame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
measure: Psychosocial function - Sleep
timeFrame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
measure: Psychosocial function - Pain
timeFrame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
measure: Psychosocial function - Barriers to Recruitment
timeFrame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
measure: Psychosocial function - Benefits and Barriers
timeFrame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
measure: Psychosocial function - Burden
timeFrame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
measure: Psychosocial function - Anxiety
timeFrame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
measure: Psychosocial function - Physical Function
timeFrame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Christina M Dieli-Conwright, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: