Prehabilitation in Esophageal Cancer Care

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prehabilitation to Enhance Functional Capacity in Esophageal Cancer Care

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Behavioral: Prehabilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supervised Prehabilitation<br>Prehabilitation will include exercise, nutrition, and anxiety-coping intervention. This group will receive a supervised, in-hospital training. | Behavioral: Prehabilitation<br>* Endurance and Resistance Exercise, Nutrition therapy, reducing intervention during the whole preoperative period<br>|
| Experimental: Home-based Prehabilitation<br>Prehabilitation will include exercise, nutrition, and anxiety-coping intervention. This group will receive a home-based training. | Behavioral: Prehabilitation<br>* Endurance and Resistance Exercise, Nutrition therapy, reducing intervention during the whole preoperative period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |