Status:
UNKNOWN
Pilot Study of a Multimodal Prehabilitation Pancreatic Cancer Program
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Pancreatic Ductal Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this research is to explore the benefits of an exercise and nutrition program during total neoadjuvant therapy (TNT) in preparation for surgery for participants that have pancreatic duc...
Detailed Description
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 name...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Adults age 18 years or older.
- Diagnosed within 8 weeks with upfront resectable, borderline resectable, or locally advanced unresectable PDAC as defined by the National Comprehensive Cancer Network (NCCN).
- Planning to undergo TNT at MGH.
- Planning to receive modified FOLFIRINOX for neoadjuvant chemotherapy.
- Planning to undergo surgical resection of PDAC at MGH.
- Verbal fluency in English.
- Exclusion Criteria
- Metastatic disease.
- Previous treatment for pancreas adenocarcinoma and no prior therapy for any cancer within 5 years.
- Known history of cognitive or psychologic impairment.
- Known history of physical impairment such as immobility, use of walking aids, or required wheelchair use.
- Known history of the following orthopedic comorbidities: advanced osteoarthritis or rheumatoid arthritis, mobility-limiting amputations, orthopedic injuries, or widespread chronic pain (e.g. fibromyalgia).
- Known history of the following pulmonary comorbidities: severe chronic obstructive pulmonary disease (COPD) defined as FEV1 ≤ 50%, emphysema, interstitial lung disease, and/or use of supplemental oxygen.
- Known history of the following cardiovascular comorbidities: uncontrolled hypertension, severe congestive heart failure (NYHA Class IV), and/or myocardial infarction within the last 6 months.
- Inability to tolerate diet through routine oral routes and/or patients with strict nutritional restrictions, allergies, and/or dietary preferences.
Exclusion
Key Trial Info
Start Date :
August 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03865875
Start Date
August 13 2019
End Date
August 1 2024
Last Update
May 17 2021
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114