Pilot Study of a Multimodal Prehabilitation Pancreatic Cancer Program
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|ClinicalTrials.gov Identifier: NCT03865875|
Recruitment Status : Not yet recruiting
First Posted : March 7, 2019
Last Update Posted : March 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Ductal Adenocarcinoma||Behavioral: Exercise Program Behavioral: Nutrition Program||Not Applicable|
This research study involves an exercise and nutrition program that will consist of twice weekly exercise sessions and discussion with a nutritionist with possible nutrition supplementation.
The names of the study interventions involved in this study are:
- Exercise Intervention
- Nutrition Intervention
The research study procedures include: screening for eligibility, study evaluations, and follow up visits.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Pilot Study of a Multimodal Prehabilitation Pancreatic Cancer Program|
|Estimated Study Start Date :||March 2019|
|Estimated Primary Completion Date :||March 2023|
|Estimated Study Completion Date :||March 2024|
Experimental: Multimodal Prehabilitation Program
Pretreatment exercise program and nutrition program
-The prehabilitation intervention will include the following components: (1) a standardized fitness program and (2) nutritional counseling and optimization. Patients are enrolled in the program within 8 weeks of being diagnosed and continued until operation
Behavioral: Exercise Program
Participants will start the exercise program within 2 weeks of enrollment and will continue until surgery. This program will consist of twice weekly individualized sessions with a trainer.
Behavioral: Nutrition Program
Each patient enrolled will undergo nutritional assessment at their initial post-enrollment visit to develop an individualized nutrition plan to be implemented up until when the patient undergoes surgery.
- Number of participants to complete prehabilitation program [ Time Frame: 1 year ]At least 50% (95% confidence interval +/- 16%) of participants will complete 50% of the components of the prehabilitation program.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03865875
|Contact: Naomi Sell, MD, MHSemail@example.com|
|Contact: Motaz Qadan, MD, PhDfirstname.lastname@example.org|
|Principal Investigator:||Motaz Qadan, MD, PhD||Massachusetts General Hospital|