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Very Low Energy Diet for Colorectal Cancer

N/A
Waitlist Available
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
BMI greater than or equal to 30kg/m2 and less than or equal to 55kg/m2
Laparoscopic surgery occurring at St. Joseph's Healthcare Hamilton
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial will study whether it is safe and possible for obese people with rectal cancer to lose weight before surgery, and if so, how much it would cost.

Eligible Conditions
  • Colorectal Cancer
  • Obesity

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Your body weight is between 66 and 121 pounds more than what is considered healthy for your height.
Select...
You had laparoscopic surgery at St. Joseph's Healthcare Hamilton.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Mesorectal Fat Volume (efficacy)
Follow-Up Rate (trial feasibility)
Incidence of Treatment-Emergent Adverse Events (safety and tolerability)
+2 more
Secondary outcome measures
Cost
Intraoperative Adverse Events
Intraoperative Blood Loss
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Very Low Energy DietExperimental Treatment1 Intervention
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.

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Who is running the clinical trial?

McMaster UniversityLead Sponsor
876 Previous Clinical Trials
2,596,004 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the intent of this medical experiment?

"The primary objective of this medical trial, to be assessed over a two-month window, is to reach the recruitment target (investigating feasibility). Other outcomes evaluated include cost comparison between Optifast 900 and other treatments during hospitalization; operative time for rectal cancer surgery in minutes; and postoperative adverse events such as surgical site infection (SSI), urinary tract infection (UTI), venous thromboembolism (VTE), pneumonia, acute kidney injury (AKI) etc. within 30 days after discharge."

Answered by AI

Are there current openings for participants in this project?

"According to clinicaltrials.gov, this medical trial is actively seeking enrolment. It was posted on August 1st 2022 and has been revised as recently as the 26th of that same month."

Answered by AI

How many participants are signed up for the study thus far?

"Affirmative. Clinicaltrials.gov suggests that this clinical trial, first publicized on August 1st 2022, is actively seeking recruits. 20 participants are sought from a single medical site."

Answered by AI
~0 spots leftby Mar 2025