Preoperative Very Low Energy Diet for Obese Rectal Cancer Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Rectal Cancer, Obesity

Intervention / Treatment
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* Dietary Supplement: Very Low Energy Diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This study is a single center, single-arm prospective cohort pilot study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Very Low Energy Diet<br>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<br>* 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.<br>* Other names: Optifast 900;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Very Low Energy Diet, Low Anterior Resection, Laparoscopy, Magnetic Resonance Imaging