Preoperative Very Low Energy Diet for Obese Rectal Cancer Patients

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04379830
• Other study ID #: 8246
• Status: Withdrawn
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: January 2024
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Rectal Cancer
• Rectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Target (trial feasibility)	20 patients over 6 months (3.33 patients per month)	6 months
Primary	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
Primary	Follow-Up Rate (trial feasibility)	Percentage of participants completing follow up appointments, questionnaires, and investigations	6 months
Primary	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
Primary	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	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
Secondary	Postoperative Length of Stay	Length of stay (LOS) in hospital postoperatively in days	1 month
Secondary	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
Secondary	Operative Time	Operative time during index surgery for rectal cancer in minutes	1 day
Secondary	Intraoperative Blood Loss	Blood loss during index surgery for rectal cancer in millilitres	1 day
Secondary	Intraoperative Adverse Events	Review of surgical dictation for any deviation from expected intraoperative processes	1 day