Preoperative Very Low Energy Diet for Obese Rectal Cancer Patients

NCT04379830 | Withdrawn DMC

• 1 other identifier: 8246
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rectal Cancer; Obesity

Keywords

Very Low Energy Diet; Low Anterior Resection; Laparoscopy; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• Cost

  6 months

• Postoperative Length of Stay

  1 month

• Postoperative Adverse Events

  1 month

• Operative Time

  1 day

• Intraoperative Blood Loss

  1 day

Study Arms (1)

Very Low Energy Diet

EXPERIMENTAL

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

Interventions

Very Low Energy Diet DIETARY_SUPPLEMENT

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.

Also known as: Optifast 900

Very Low Energy Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

Rectal Neoplasms; Obesity

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a single center, single-arm prospective cohort pilot study.

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 8, 2020
• Study Start: August 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: June 30, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)