Prehabilitation for Esophageal Resection Surgery
Conditions
Esophageal Cancer - Surgery
Conditions: official terms
Esophageal Neoplasms
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Intervention
Name: Exercise
Type: Behavioral
Overall Status
Recruiting
Summary
Consenting patients scheduled for esophageal resection surgery will be randomized to receive standard nutrition counseling (including nutritional supplements as needed) or standard nutrition counseling and exercise 4 weeks before surgery and 8 weeks after surgery.

It is hypothesized that, compared with the group receiving nutrition alone, the addition of physical exercise to nutrition starting before surgery and continuing for 8 weeks after surgery will have a significantly greater impact on functional walking capacity during the prehabilitation period and during the postoperative period, and on the incidence of postoperative pulmonary complications.
Detailed Description
A randomized controlled study in patients undergoing esophageal resection for cancer to determine the impact of multimodal prehabilitation on functional exercise capacity and postoperative pulmonary complications. Patients who accept to be enrolled in the study will be randomized to receive either a standard nutritional intervention (including supplements as needed) as per current institution policy or standard nutritional intervention (including supplements as needed) combined with a physical exercise program before and after surgery.

Specific aims

The aims of this research project are the following:

1. To determine the extent in which a multimodal prehabilitation regimen optimizes functional recovery in patients suffering from esophageal cancer and the incidence of postoperative pulmonary complications.

2. To understand further which measures of immediate surgical recovery are sensitive to prehabilitation interventions, and predict change in later outcome measures.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- 18 and older

- referred electively for resection of malignant esophageal lesion

Exclusion Criteria:

- American Society of Anesthesiologists (ASA) health status class 4-5

- Dementia and psychosis

- Disabling orthopedic and neuromuscular disease

- Severe cardiac abnormalities

- Severe end-organ disease such as cardiac failure (New York Heart Association classes I-IV)

- COPD

- renal failure (creatinine > 1.5 mg/dl, and hepatic failure ALT and AST >50% over the normal range)

- Morbid obesity (BMI >30)

- Anemia (hematocrit < 30 %, haemoglobin <10g/dl, albumin < 25mg/dl)
Location
Montreal General Hospital
Montreal, Quebec, Canada
Status: Recruiting
Contact: Dr.Franco Carli, M.D. - (514) 934-1934 - franco.carli@mcgill.ca
Start Date
January 2013
Completion Date
September 2015
Sponsors
Franco Carli
Source
McGill University Health Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page