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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
45
Aerobic and resistance exercise with orally consumed pre-packed protein supplement
Aerobic and resistance exercise
Stretching
Dana Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGExercise Session Attendance Rate
The primary outcome is feasibility. Feasibility of the resistance exercise (RE) +protein supplementation (PS) intervention will be defined as the proportion of exercise sessions attended and consumption of the PS. The intervention is considered feasible if the proportion of enrolled participants who complete the exercise sessions and daily PS is ≥70%, respectively.
Time frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
Protein Supplementation (PS) Rate
The primary outcome is feasibility. Feasibility of the resistance exercise (RE) +protein supplementation (PS) intervention will be defined as the proportion of exercise sessions attended and consumption of the PS. The intervention is considered feasible if the proportion of enrolled participants who complete the exercise sessions and daily PS is ≥70%, respectively.
Time frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
Skeletal Muscle Mass Change
Skeletal muscle mass will be assessed by standardized body composition analysis of clinical CT scans.
Time frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
Tissue Wasting Biomarker Change
Plasma biomarkers will be analyzed for IL-6, MCP-1, TNF-RII, and branched chain amino acids.
Time frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
Physical function - Margaria Stair Climb
Functional power will be measured using the Margaria Stair Climb test. Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test. For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
Time frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
Muscular Strength
Muscular strength will be assessed with a 10 repetition maximum test. Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test. For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI
Time frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
Physical Fitness - Performance
Physical Fitness will be measured by the short physical performance battery (SPPB). Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test. For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
Time frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
Physical Fitness - Sit to Stand
Physical Fitness will be measured by the sit to stand test. Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test. For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
Time frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
Gait Speed
Gait Speed will be measured by a short walk over a 6-meter flat distance at usual and fast speeds. Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test. For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
Time frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
Physical Function - Handgrip Strength
Handgrip strength will be measured by a hand-held dynamometer. Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test. For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
Time frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
Physical Function - 6 minute walk test
Physical function will be assessed with the 6 minute walk test (6MWT). Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test. For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
Time frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
Psychosocial function - Fatigue
Fatigue will be measured by the Brief Fatigue Inventory (BFI). Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test. For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
Time frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
Psychosocial function - Quality of Life
Quality of life will be assessed by the functional assessment of cancer therapy - Hepatobiliary (FACT-Hep). Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test. For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
Time frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
Psychosocial function - Depression
Depression will be assessed by the Center for Epidemiologic Studies Depression scale. Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test. For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
Time frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
Psychosocial function - Sleep
Sleep will be assessed by the Pittsburg sleep quality index (PSQI). Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test. For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
Time frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
Psychosocial function - Pain
Pain will be assessed by the Brief Pain Inventory. Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test. For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
Time frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
Psychosocial function - Barriers to Recruitment
Barriers will be assessed by the Barriers to Recruitment Participation Questionnaire. Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test. For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
Time frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
Psychosocial function - Benefits and Barriers
Benefits \& Barriers will be assessed by the Exercise Benefits/Barriers Scale Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test. For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
Time frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
Psychosocial function - Burden
Burden will be assessed by the Perceived Research Burden Assessment. Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test. For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
Time frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
Psychosocial function - Anxiety
Anxiety will be assessed by the The State-Trait Anxiety Inventor. Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test. For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
Time frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
Psychosocial function - Physical Function
Physical Function will be assessed by the Patient Reported Outcome Measure Information System (PROMIS) Physical Function-10 scale. Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test. For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
Time frame: Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks)
Christina M Dieli-Conwright, PhD, MPH
CONTACT
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