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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resistance Training (RT) and Protein Supplementation (PS) | Experimental | 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. |
|
| Resistance Training (RT) | Experimental | 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. |
|
| Attention Control (AC) | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resistance Training (RT) and Protein Supplementation (PS) | Behavioral | Aerobic and resistance exercise with orally consumed pre-packed protein supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Tissue Wasting Biomarker Change |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christina M Dieli-Conwright, PhD, MPH | Contact | 617-582-8321 | ChristinaM_Dieli-Conwright@dfci.harvard.edu | |
| Christina M Dieli-Conwright, PhD, MPH | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Christina M Dieli-Conwright, PhD, MPH | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Data can be shared no earlier than 1 year following the date of publication
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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| Resistance Training (RT) | Behavioral | Aerobic and resistance exercise |
|
| Attention Control (AC | Behavioral | Stretching |
|
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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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