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Pilot Study of a Multimodal Prehabilitation Pancreatic Cancer Program

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ClinicalTrials.gov Identifier: NCT03865875
Recruitment Status : Not yet recruiting
First Posted : March 7, 2019
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Motaz Qadan, Massachusetts General Hospital

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)

Condition or disease Intervention/treatment Phase
Pancreatic Ductal Adenocarcinoma Behavioral: Exercise Program Behavioral: Nutrition Program Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Pilot Study of a Multimodal Prehabilitation Pancreatic Cancer Program
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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.

Behavioral: 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 Measures :
  1. Number of participants to complete prehabilitation program [ Time Frame: 1 year ]
    At least 50% (95% confidence interval +/- 16%) of participants will complete 50% of the components of the prehabilitation program.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03865875


Contacts
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Contact: Naomi Sell, MD, MHS 650-868-9440 nsell@partners.org
Contact: Motaz Qadan, MD, PhD 617-643-5153 mqadan@mgh.harvard.edu

Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Motaz Qadan, MD, PhD Massachusetts General Hospital

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Responsible Party: Motaz Qadan, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03865875     History of Changes
Other Study ID Numbers: 18-635
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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
URL: http://www.dfhcc.harvard.edu/crs-resources/ODQ_Documents/02_CT.GOV_CTRP/Guidance_on_Data_Sharing.pdf

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Motaz Qadan, Massachusetts General Hospital:
Pancreatic Ductal Adenocarcinoma
Total Neoadjuvant Therapy
Prehabilitation
Exercise
Nutrition
Optimization
Surgery

Additional relevant MeSH terms:
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Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Adenocarcinoma
Carcinoma
Digestive System Diseases
Endocrine System Diseases