Clinical trial NCT03865875: Pilot Study of a Multimodal Prehabilitation Pancreatic Cancer Program
Official title: Pilot Study of a Multimodal Prehabilitation Pancreatic Cancer Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Ductal Adenocarcinoma
Keywords: Pancreatic Ductal Adenocarcinoma
Total Neoadjuvant Therapy
Prehabilitation
Exercise
Nutrition
Optimization
Surgery
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2019-03-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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 ductal adenocarcinoma (PDAC)

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants to complete prehabilitation program
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Motaz Qadan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: