Prehabilitation in Esophageal Cancer Care
Primary Purpose
Esophageal Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Prehabilitation
Sponsored by
About this trial
This is an interventional supportive care trial for Esophageal Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients with non-metastatic esophageal cancer undergoing neo-adjuvant chemotherapy and surgery.
Exclusion Criteria:
- co-morbid medical, physical and mental conditions that contraindicate exercise or oral nutrition
Sites / Locations
- McGill University Health CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Supervised Prehabilitation
Home-based Prehabilitation
Arm Description
Prehabilitation will include exercise, nutrition, and anxiety-coping intervention. This group will receive a supervised, in-hospital training.
Prehabilitation will include exercise, nutrition, and anxiety-coping intervention. This group will receive a home-based training.
Outcomes
Primary Outcome Measures
Oxygen consumption (VO2)
Oxygen consumption at anaerobic threshold (VO2 at AT) measured with cardiopulmonary exercise testing (CPET)
Oxygen consumption (VO2)
Oxygen consumption at anaerobic threshold (VO2 at AT) measured with cardiopulmonary exercise testing (CPET)
Secondary Outcome Measures
Full Information
NCT ID
NCT04581005
First Posted
August 15, 2020
Last Updated
September 24, 2021
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
1. Study Identification
Unique Protocol Identification Number
NCT04581005
Brief Title
Prehabilitation in Esophageal Cancer Care
Official Title
Prehabilitation to Enhance Functional Capacity in Esophageal Cancer Care
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 19, 2019 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prehabilitation utilizes the preoperative period to prevent or attenuate the treatment-related functional decline and its consequences. This project aims at testing feasibility and effectiveness of multimodal prehabilitation in esophageal cancer care.
Detailed Description
While evidence on prehabilitation is mounting, upper gastrointestinal surgery still remains under-investigated. This trial aims to explore the effect of prehabilitation over the whole perioperative trajectory, including neo-adjuvant treatment (NAT).
Multimodal prehabilitation includes exercise, nutrition therapy, and mental distress coping strategies. In the context of a multimodal approach, the two groups follow different exercise prescriptions: high-intensity interval supervised training prescribed accordingly cardiopulmonary exercise testing (CPET)-derived variables, versus a home-based program. For both groups, multimodal prehabilitation is prescribed over the whole preoperative period, including during NAT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Supervised Prehabilitation
Arm Type
Experimental
Arm Description
Prehabilitation will include exercise, nutrition, and anxiety-coping intervention.
This group will receive a supervised, in-hospital training.
Arm Title
Home-based Prehabilitation
Arm Type
Experimental
Arm Description
Prehabilitation will include exercise, nutrition, and anxiety-coping intervention.
This group will receive a home-based training.
Intervention Type
Behavioral
Intervention Name(s)
Prehabilitation
Intervention Description
Endurance and Resistance Exercise, Nutrition therapy, reducing intervention during the whole preoperative period
Primary Outcome Measure Information:
Title
Oxygen consumption (VO2)
Description
Oxygen consumption at anaerobic threshold (VO2 at AT) measured with cardiopulmonary exercise testing (CPET)
Time Frame
Change from baseline to 2 months after surgery
Title
Oxygen consumption (VO2)
Description
Oxygen consumption at anaerobic threshold (VO2 at AT) measured with cardiopulmonary exercise testing (CPET)
Time Frame
Change from baseline to post neo-adjuvant therapy (average duration 6-8 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with non-metastatic esophageal cancer undergoing neo-adjuvant chemotherapy and surgery.
Exclusion Criteria:
co-morbid medical, physical and mental conditions that contraindicate exercise or oral nutrition
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco Carli, MD MPhil
Phone
514-934-1934
Ext
43274
Email
franco.carli@mcgill.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Enrico M Minnella, MD PhD
Phone
514-934-1934
Ext
43274
Email
enrico.minnella@mail.mcgill.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enrico M Minnella, MD PhD
Organizational Affiliation
McGill University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Carli, MD MPhil
Phone
5149341934
Ext
43728
Email
franco.carli@mcgill.ca
First Name & Middle Initial & Last Name & Degree
Enrico M Minnella, MD PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prehabilitation in Esophageal Cancer Care
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