Pancreatic Cancer Clinical Trial
Official title:
Resistance Exercise Combined With Protein Supplementation for Skeletal Muscle Mass in People With Pancreatic Cancer Undergoing Chemotherapy: The RE-BUILD Trial
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
Status | Recruiting |
Enrollment | 45 |
Est. completion date | August 15, 2025 |
Est. primary completion date | January 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Exercise 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. | Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks) | |
Primary | 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. | Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks) | |
Secondary | Skeletal Muscle Mass Change | Skeletal muscle mass will be assessed by standardized body composition analysis of clinical CT scans. | Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks) | |
Secondary | Tissue Wasting Biomarker Change | Plasma biomarkers will be analyzed for IL-6, MCP-1, TNF-RII, and branched chain amino acids. | Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks) | |
Secondary | 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. | Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks) | |
Secondary | 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 | Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks) | |
Secondary | 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. | Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks) | |
Secondary | 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. | Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks) | |
Secondary | 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. | Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks) | |
Secondary | 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. | Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks) | |
Secondary | 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. | Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks) | |
Secondary | 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. | Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks) | |
Secondary | 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. | Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks) | |
Secondary | 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. | Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks) | |
Secondary | 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. | Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks) | |
Secondary | 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. | Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks) | |
Secondary | 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. | Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks) | |
Secondary | 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. | Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks) | |
Secondary | 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. | Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks) | |
Secondary | 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. | Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks) | |
Secondary | 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. | Evaluating change between baseline, mid-intervention, and post-intervention (up to 16 weeks) |
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