Clinical trial NCT01666158: Prehabilitation for Esophageal Resection Surgery
Official title: Prehabilitation to Enhance Postoperative Functional Capacity Following Esophageal Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Cancer
Surgery
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2012-08-16
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility 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)

Primary outcomes:
measure: 6 minute walk test (6MWT)
timeFrame: up to 8 weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
Study officials:
affiliation: Montreal University Health Centre
name: Franco Carli, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mayo NE, Feldman L, Scott S, Zavorsky G, Kim DJ, Charlebois P, Stein B, Carli F. Impact of preoperative change in physical function on postoperative recovery: argument supporting prehabilitation for colorectal surgery. Surgery. 2011 Sep;150(3):505-14. doi: 10.1016/j.surg.2011.07.045.
citation: Minnella EM, Awasthi R, Loiselle SE, Agnihotram RV, Ferri LE, Carli F. Effect of Exercise and Nutrition Prehabilitation on Functional Capacity in Esophagogastric Cancer Surgery: A Randomized Clinical Trial. JAMA Surg. 2018 Dec 1;153(12):1081-1089. doi: 10.1001/jamasurg.2018.1645.