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Preoperative Very Low Energy Diet for Obese Rectal Cancer Patients

NCT04379830 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-01-05

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2023-03-01
Completion
2023-06-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04379830 on ClinicalTrials.gov