Preoperative Very Low Energy Diet for Obese Rectal Cancer Patients

The Effect of Preoperative Very Low Energy Diet on Mesorectal Volume in Rectal Cancer Patients: A Pilot Study

This pilot study will aim to determine the feasibility, safety, and cost associated with a preoperative VLED for obese rectal cancer patients. Ultimately, the investigators seek to provide evidence that may inform the development of a standardized preoperative weight loss protocol in obese rectal cancer patients.

Study Overview

• Status: Withdrawn
• Conditions: Obesity; Rectal Cancer
• Intervention / Treatment: Dietary supplement: Very Low Energy Diet

Detailed Description

This study is a single center, single-arm prospective cohort pilot study with a primary aim of determining the feasibility, safety, and cost associated with a preoperative VLED for obese rectal cancer patients. Efficacy of preoperative VLED in this study population will be assessed through measures of mesorectal fat volume with MRI at two separate time points, prior to commencing a pre-operative VLED diet and immediately prior to patients undergoing laparoscopic low anterior resection for rectal cancer, to objectively quantify the proportion of mesorectal fat loss in response to VLED. Secondary aims include an assessment of whether preoperative weight loss contributes to improved intraoperative outcomes including operative time, blood loss, and rate of conversion to open procedure. Furthermore, postoperative outcomes including rates of 30-day complication rate, hospital stay, among others will be evaluated.

Optifast 900 will be administered to enrolled patients over a 3-week period immediately prior to their scheduled elective operation date. Compliance will be measured with a food diary. Two MRIs of the rectum will be obtained: one prior to the commencement of VLED and one following the completion of the VLED before the scheduled operation date. The first MRI will be a clinically indicated preoperative staging investigation, while the second MRI will be used purely for research purposes. Patients will be enrolled in an enhanced recovery after surgery (ERAS) for colorectal surgery program. All patients will be followed by their surgeon as per that individual surgeon's postoperative surveillance schedule. At the routine one-month follow-up visit, patients will see the surgeon as well as a study investigator who will complete a standardized follow up questionnaire, focusing on adverse events and functional independence. Research personnel and study investigators will follow patients throughout their postoperative course in hospital and note any secondary outcomes including laboratory tests or adverse events through the electronic patient chart.

Ultimately, the investigators seek to provide evidence that may inform the development of a standardized preoperative weight loss protocol in obese rectal cancer patients.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • St. Joseph's Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18 years of age or older
• BMI greater than or equal to 30kg/m2 and less than or equal to 55kg/m2
• Patients undergoing elective surgery
• Documented pathological diagnosis of rectal adenocarcinoma
• Preoperative staging investigations consistent with stage I, II, and III disease
• Laparoscopic surgery occurring at St. Joseph's Healthcare Hamilton

Exclusion Criteria:

• BMI less than 30kg/m2
• Contraindications to magnetic resonance imaging, general anesthesia, or major colorectal surgery
• Patient undergoing open surgery
• Patients undergoing emergency or palliative surgery
• Preoperative staging investigations consistent with metastatic disease
• Allergy or contraindication to the use of Optifast
• Prior pelvic colorectal surgery or bariatric surgery
• Enrolled in any other clinical trials or prospective studies where similar outcomes are measured
• Severe, chronic cardiovascular disease (i.e. recent myocardial infarction, unstable angina), renal disease, or hepatic dysfunction
• Patients with pharmacologically managed diabetes mellitus
• Pregnant and/or breastfeeding patients
• Inability to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Very Low Energy Diet; VLED in its entirety is composed of the following for 3-weeks preoperatively: Optifast 900 with a single piece of fruit for breakfast, Optifast 900 with one cup of vegetables for lunch, and Optifast 900 with one cup of vegetables for dinner. Patients will be provided written information on fruits and vegetables permitted for consumption with Optifast 900 to provide a total energy intake between 450 and 800 kilocalories (kcal) per day.

Dietary supplement: Very Low Energy Diet; Optifast 900 is an FDA approved commercial nutritionally complete meal replacement product manufactured and marketed in the United States. Optifast 900 will be employed as part of the VLED in the present study in the following manner: Optifast 900 with a single piece of fruit for breakfast, Optifast 900 with one cup of vegetables for lunch, and Optifast 900 with one cup of vegetables for dinner. Patients will be provided written information on fruits and vegetables permitted for consumption with Optifast 900 to provide a total energy intake between 450 and 800 kilocalories (kcal) per day.; Other Names: Optifast 900

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment Target (trial feasibility)	20 patients over 6 months (3.33 patients per month)	6 months
Medication Compliance Rate (trial feasibility)	Percentage of participants adhering to prescribed Optifast 900 dosages and percentage of Optifast 900 dosages missed by study participants	6 months
Follow-Up Rate (trial feasibility)	Percentage of participants completing follow up appointments, questionnaires, and investigations	6 months
Incidence of Treatment-Emergent Adverse Events (safety and tolerability)	Change in functional independence from the preoperative, pre-VLED period to 1-month postoperatively using the World Health Organization Disability Assessment Schedule 2.0	2 months
Change in Mesorectal Fat Volume (efficacy)	Change in mesolectal fat volume on MRI from prior to 3 weeks of preoperative VLED to immediately following completion of preoperative VLED	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost	Comparison of the cost (in Canadian dollars) of a 3-week course of Optifast 900 to the cost associated with length of hospital stay and additional treatments during index hospitalization (e.g. reoperation, packed red blood cell transfusion)	6 months
Postoperative Length of Stay	Length of stay (LOS) in hospital postoperatively in days	1 month
Postoperative Adverse Events	All adverse events attributable to the index surgery for up to 30 days following hospital discharge, including: surgical site infection (SSI), urinary tract infection (UTI), venous thromboembolism (VTE), pneumonia, acute kidney injury (AKI), postoperative ileus, anastomotic leak, wound dehiscence, erectile dysfunction, and readmission	1 month
Operative Time	Operative time during index surgery for rectal cancer in minutes	1 day
Intraoperative Blood Loss	Blood loss during index surgery for rectal cancer in millilitres	1 day
Intraoperative Adverse Events	Review of surgical dictation for any deviation from expected intraoperative processes	1 day

Collaborators and Investigators

• Sponsor: McMaster University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): March 1, 2023
• Study Completion (Estimated): June 30, 2023

Study Registration Dates

• First Submitted: April 30, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 8, 2020

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Magnetic Resonance Imaging; Very Low Energy Diet; Laparoscopy; Low Anterior Resection
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: 8246

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes