Recruiting

Prehabilitation Program

Sponsor:

Massachusetts General Hospital

Code:

NCT03865875

Conditions

Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Exercise Program

Nutrition Program

Study Details

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)

Conditions

Pancreatic Ductal Adenocarcinoma

Study ID

NCT03865875

Start date

Aug 13, 2019

Status verified date

May, 2021

Completion date

Aug, 2024

Anticipated

Primary completion date

Aug, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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

Interventions

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.

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.

Primary outcome measure

  • Number of participants to complete prehabilitation program [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Naomi Sell, MD, MHS

650-868-9440nsell@partners.org

Motaz Qadan, MD, PhD

617-643-5153mqadan@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Motaz Qadan, MD, PhD

617-643-5153mqadan@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

May 17, 2021

Last verified

May, 2021

Keywords

  • Pancreatic Ductal Adenocarcinoma
  • Total Neoadjuvant Therapy
  • Prehabilitation
  • Exercise
  • Nutrition
  • Optimization
  • Surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2021-05-17.