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Pilot Study of a Multimodal Prehabilitation Pancreatic Cancer Program

Primary Purpose

Pancreatic Ductal Adenocarcinoma

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exercise Program

Nutrition Program

About this trial

This is an interventional health services research trial for Pancreatic Ductal Adenocarcinoma focused on measuring Pancreatic Ductal Adenocarcinoma, Total Neoadjuvant Therapy, Prehabilitation, Exercise, Nutrition, Optimization, Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Multimodal Prehabilitation Program

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03865875

First Posted

March 5, 2019

Last Updated

May 13, 2021

Sponsor

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03865875

Brief Title

Pilot Study of a Multimodal Prehabilitation Pancreatic Cancer Program

Official Title

Pilot Study of a Multimodal Prehabilitation Pancreatic Cancer Program

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Recruiting

Study Start Date

August 13, 2019 (Actual)

Primary Completion Date

August 2023 (Anticipated)

Study Completion Date

August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Ductal Adenocarcinoma

Keywords

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

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Multimodal Prehabilitation Program

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Exercise Program

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Nutrition Program

Intervention Description

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 Information:

Title

Number of participants to complete prehabilitation program

Description

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

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Naomi Sell, MD, MHS

Phone

650-868-9440

nsell@partners.org

First Name & Middle Initial & Last Name or Official Title & Degree

Motaz Qadan, MD, PhD

Phone

617-643-5153

mqadan@mgh.harvard.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Motaz Qadan, MD, PhD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Motaz Qadan, MD, PhD

Phone

617-643-5153

mqadan@mgh.harvard.edu

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication

IPD Sharing Access Criteria

MGH - Contact the Partners Innovations team at http://www.partners.org/innovation

IPD Sharing URL

http://www.dfhcc.harvard.edu/crs-resources/ODQ_Documents/02_CT.GOV_CTRP/Guidance_on_Data_Sharing.pdf

Learn more about this trial

Pilot Study of a Multimodal Prehabilitation Pancreatic Cancer Program

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