Prehabilitation in Esophageal Cancer Care
Prehabilitation to Enhance Functional Capacity in Esophageal Cancer Care
1 other identifier
interventional
54
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 19, 2019
CompletedFirst Submitted
Initial submission to the registry
August 15, 2020
CompletedFirst Posted
Study publicly available on registry
October 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedSeptember 28, 2021
September 1, 2021
2.8 years
August 15, 2020
September 24, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Oxygen consumption (VO2)
Oxygen consumption at anaerobic threshold (VO2 at AT) measured with cardiopulmonary exercise testing (CPET)
Change from baseline to 2 months after surgery
Oxygen consumption (VO2)
Oxygen consumption at anaerobic threshold (VO2 at AT) measured with cardiopulmonary exercise testing (CPET)
Change from baseline to post neo-adjuvant therapy (average duration 6-8 weeks)
Study Arms (2)
Supervised Prehabilitation
EXPERIMENTALPrehabilitation will include exercise, nutrition, and anxiety-coping intervention. This group will receive a supervised, in-hospital training.
Home-based Prehabilitation
EXPERIMENTALPrehabilitation will include exercise, nutrition, and anxiety-coping intervention. This group will receive a home-based training.
Interventions
Endurance and Resistance Exercise, Nutrition therapy, reducing intervention during the whole preoperative period
Eligibility Criteria
You may qualify if:
- Patients with non-metastatic esophageal cancer undergoing neo-adjuvant chemotherapy and surgery.
You may not qualify if:
- co-morbid medical, physical and mental conditions that contraindicate exercise or oral nutrition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
McGill University Health Centre
Montreal, Quebec, H3G 1A4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Enrico M Minnella, MD PhD
McGill University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 15, 2020
First Posted
October 9, 2020
Study Start
August 19, 2019
Primary Completion
June 1, 2022
Study Completion
November 1, 2022
Last Updated
September 28, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share