Pilot Study of a Multimodal Prehabilitation Pancreatic Cancer Program

NCT03865875 | Unknown

• 1 other identifier: 18-635
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of participants to complete prehabilitation program

  At least 50% (95% confidence interval +/- 16%) of participants will complete 50% of the components of the prehabilitation program.

  1 year

Study Arms (1)

Multimodal Prehabilitation Program

EXPERIMENTAL

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; Behavioral: Nutrition Program

Interventions

Exercise Program BEHAVIORAL

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.

Multimodal Prehabilitation Program

Nutrition Program BEHAVIORAL

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.

Multimodal Prehabilitation Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

Resistance Training; Food Assistance

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Public Assistance; Financing, Government; Financing, Organized; Economics; Health Care Economics and Organizations

Study Officials

• Motaz Qadan, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naomi Sell, MD, MHS

CONTACT

650-868-9440; nsell@partners.org

Motaz Qadan, MD, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: March 7, 2019
• Study Start: August 13, 2019
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2024
• Last Updated: May 17, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: MGH - Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (1)