Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): There were no patients recruited during the trial period. This was a result of: 1) COVID-19 pandemic; 2) MRIs were done prior to patients being seen in consultation, which made them ineligible for enrolment.
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Obesity | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Very Low Energy Diet | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Very Low Energy Diet
- description
- 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.
- interventionNames
- Dietary Supplement: Very Low Energy Diet
Primary outcomes (5)
- measure
- Recruitment Target (trial feasibility)
- timeFrame
- 6 months
- description
- 20 patients over 6 months (3.33 patients per month)
- measure
- Medication Compliance Rate (trial feasibility)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available