Pilot Study of a Multimodal Prehabilitation Pancreatic Cancer Program

Pancreatic Ductal Adenocarcinoma Clinical Trial

Official title:

Pilot Study of a Multimodal Prehabilitation Pancreatic Cancer Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03865875
• Other study ID #: 18-635
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Ductal Adenocarcinoma

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