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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03865875
Other study ID # 18-635
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 13, 2019
Est. completion date August 2024

Study information

Verified date May 2021
Source Massachusetts General Hospital
Contact Naomi Sell, MD, MHS
Phone 650-868-9440
Email nsell@partners.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date August 2024
Est. primary completion date August 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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