Pilot Study of a Multimodal Prehabilitation Pancreatic Cancer Program

  • STATUS
    Recruiting
  • End date
    Aug 28, 2024
  • participants needed
    40
  • sponsor
    Massachusetts General Hospital
Updated on 28 May 2021

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.

Details
Condition Pancreatic Ductal Adenocarcinoma
Treatment Exercise Program, Nutrition Program
Clinical Study IdentifierNCT03865875
SponsorMassachusetts General Hospital
Last Modified on28 May 2021

Eligibility

Yes No Not Sure

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
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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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