Back to resultsResistance Exercise Combined With Protein Supplementation in People With Pancreatic Cancer: The RE-BUILD Trial
Primary Purpose
Pancreatic Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resistance Training (RT) and Protein Supplementation (PS)
Resistance Training (RT)
Attention Control (AC
Sponsored by
About this trial
This is an interventional screening trial for Pancreatic Cancer focused on measuring Pancreatic Cancer
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.
Sites / Locations
- Dana Farber Cancer InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Resistance Training (RT) and Protein Supplementation (PS)
Resistance Training (RT)
Attention Control (AC)
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Skeletal Muscle Mass Change
Skeletal muscle mass will be assessed by standardized body composition analysis of clinical CT scans.
Tissue Wasting Biomarker Change
Plasma biomarkers will be analyzed for IL-6, MCP-1, TNF-RII, and branched chain amino acids.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05356117
First Posted
April 15, 2022
Last Updated
February 16, 2023
Sponsor
Dana-Farber Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT05356117
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
August 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Pancreatic Cancer
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Resistance Training (RT) and Protein Supplementation (PS)
Arm Type
Experimental
Arm Description
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.
Arm Title
Resistance Training (RT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Attention Control (AC)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Resistance Training (RT) and Protein Supplementation (PS)
Intervention Description
Aerobic and resistance exercise with orally consumed pre-packed protein supplement
Intervention Type
Behavioral
Intervention Name(s)
Resistance Training (RT)
Intervention Description
Aerobic and resistance exercise
Intervention Type
Behavioral
Intervention Name(s)
Attention Control (AC
Intervention Description
Stretching
Primary Outcome Measure Information:
Title
Exercise Session Attendance Rate
Description
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)
Title
Protein Supplementation (PS) Rate
Description
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)
Secondary Outcome Measure Information:
Title
Skeletal Muscle Mass Change
Description
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)
Title
Tissue Wasting Biomarker Change
Description
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)
Title
Physical function - Margaria Stair Climb
Description
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)
Title
Muscular Strength
Description
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)
Title
Physical Fitness - Performance
Description
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)
Title
Physical Fitness - Sit to Stand
Description
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)
Title
Gait Speed
Description
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)
Title
Physical Function - Handgrip Strength
Description
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)
Title
Physical Function - 6 minute walk test
Description
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)
Title
Psychosocial function - Fatigue
Description
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)
Title
Psychosocial function - Quality of Life
Description
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)
Title
Psychosocial function - Depression
Description
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)
Title
Psychosocial function - Sleep
Description
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)
Title
Psychosocial function - Pain
Description
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)
Title
Psychosocial function - Barriers to Recruitment
Description
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)
Title
Psychosocial function - Benefits and Barriers
Description
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)
Title
Psychosocial function - Burden
Description
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)
Title
Psychosocial function - Anxiety
Description
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)
Title
Psychosocial function - Physical Function
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christina M Dieli-Conwright, PhD, MPH
Phone
617-582-8321
Email
ChristinaM_Dieli-Conwright@dfci.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Christina M Dieli-Conwright, PhD, MPH
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina M Dieli-Conwright, PhD, MPH
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina M Dieli-Conwright, PhD, MPH
Phone
617-632-3800
Email
ChristinaM_Dieli-Conwright@dfci.harvard.edu
First Name & Middle Initial & Last Name & Degree
PhD, MPH
First Name & Middle Initial & Last Name & Degree
Christina M Dieli-Conwright, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
Learn more about this trial
Resistance Exercise Combined With Protein Supplementation in People With Pancreatic Cancer: The RE-BUILD Trial
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