Pilot Study of a Multimodal Prehabilitation Pancreatic Cancer Program
Status unconfirmed · Not applicable
Conditions studied: Pancreatic Ductal Adenocarcinoma
In brief
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 ductal adenocarcinoma (PDAC)
Key facts
- Study ID
- NCT03865875
- Run by
- Massachusetts General Hospital
- People needed
- 40
- Starts
- 2019-08-13
- Expected to finish
- 2024-08-01
- Last updated by the study team
- 2021-05-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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