Mechanistic Prehabilitation

NCT01919541 | Withdrawn DMC

• 1 other identifier: 13-127-GEN
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesize that individuals who receive a personalized 4 week prehabilitation program consisting of exercise and nutrition counselling with post-workout whey protein supplementation will show, before colorectal surgery, improved insulin sensitivity, inflammatory profile, and substrate utilization compared to baseline measures. These results will translate into a higher functional capacity before surgery as demonstrated by an improvement in 6-minute walking test.

Conditions

Colon Cancer; Rectal Cancer

Keywords

Colorectal Surgery

Outcome Measures

Primary Outcomes (1)

• Protein Synthesis

  The change in whole body protein synthesis, measured using stable isotope technology, from baseline to date of surgery, will be documented, in response to hyperinsulinemia with the use of a hyperinsulinemic euglycemic hyperaminoacidemic clamp.

  up to 4 weeks before surgery

Study Arms (1)

Prehabilitation

OTHER

All patients will receive a prehabilitation program involving an individualized exercise and nutrition program 4 weeks before surgery. Whole body protein kinetics and insulin resistance will be determined at the beginning of the program and at the end of the program.

Other: Prehabilitation; Device: hyperinsulinemic euglycemic isoaminoacid clamp; Device: hyperinsulinemic euglycemic hyperaminoacid clamp; Dietary Supplement: whey protein supplementation

Interventions

Prehabilitation OTHER

All patients will receive a prehabilitation program, which involves a personalized exercise component provided by a kinesiologist.

Prehabilitation

hyperinsulinemic euglycemic isoaminoacid clamp DEVICE

A hyperinsulinemic euglycemic isoaminoacid clamp followed by a hyperinsulinemic euglycemic hyperaminoacid clamp performed at baseline and immediately before surgery will provide insight into insulin resistance of glucose and protein metabolism in colorectal cancer patients pre- and post-intervention. Similarly, simultaneous infusions of leucine and glucose stable isotopes will provide insight into baseline and interventional effects of the program on whole body leucine and glucose kinetics.

Prehabilitation

hyperinsulinemic euglycemic hyperaminoacid clamp DEVICE

Prehabilitation

whey protein supplementation DIETARY_SUPPLEMENT

Prehabilitation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients scheduled for elective colorectal surgery for cancer
• years and older

You may not qualify if:

• American Society of Anesthesiologists (ASA) health status class 4-5
• disabling co-morbid physical and mental conditions (e.g. orthopedic and neuromuscular disease, dementia, psychosis)
• endocrine disorders (diabetes or hemoglobin A1C\>6, hyper and hypothyrodisim)
• steroid consumption
• cardiac failure (New York Heart Association classes I-IV)
• chronic obstructive pulmonary disease
• renal failure (creatinine \> 115µmol/l)
• hepatic failure (liver aminotranferases \>50% the normal range)
• morbid obesity (BMI \>40)
• anemia (hematocrit \< 30 %, haemoglobin \<100 g/L, albumin \< 25 g/L)
• poor comprehension of English or French

Sponsors & Collaborators

• Franco Carli: lead

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Related Publications (1)

• Li C, Carli F, Lee L, Charlebois P, Stein B, Liberman AS, Kaneva P, Augustin B, Wongyingsinn M, Gamsa A, Kim DJ, Vassiliou MC, Feldman LS. Impact of a trimodal prehabilitation program on functional recovery after colorectal cancer surgery: a pilot study. Surg Endosc. 2013 Apr;27(4):1072-82. doi: 10.1007/s00464-012-2560-5. Epub 2012 Oct 9.

  PMID: 23052535 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Franco Carli, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 31, 2013
• First Posted: August 9, 2013
• Study Start: December 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 22, 2018

Record last verified: 2015-09

Locations

CA (1)