Rectal CancerNCT04379830
Preoperative Very Low Energy Diet for Obese Rectal Cancer Patients
A study testing Very Low Energy Diet in people with Rectal Cancer and Obesity, run by McMaster University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rectal Cancer, Obesity
- What is being tested?
- Very Low Energy Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Preoperative Very Low Energy Diet on Mesorectal Volume in Rectal Cancer Patients: A Pilot Study
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.
Read the detailed 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.
- Conditions
- Rectal Cancer, Obesity
- Being tested
- Very Low Energy Diet
- Keywords
- Very Low Energy Diet, Low Anterior Resection, Laparoscopy, Magnetic Resonance Imaging
- Medical subject headings
- Rectal Neoplasms, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very Low Energy DietDietary supplement
Also called Optifast 900
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.
| Study group | Role | What they receive |
|---|---|---|
| Very Low Energy Diet | Experimental | 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. Receives: Dietary Supplement: Very Low Energy Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Target (trial feasibility)
20 patients over 6 months (3.33 patients per month)
Measured: 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
Measured: 6 months
Follow-Up Rate (trial feasibility)
Percentage of participants completing follow up appointments, questionnaires, and investigations
Measured: 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
Measured: 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
Measured: 1 month
Secondary outcomes (6)
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)
Measured: 6 months
Postoperative Length of Stay
Length of stay (LOS) in hospital postoperatively in days
Measured: 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
Measured: 1 month
Operative Time
Operative time during index surgery for rectal cancer in minutes
Measured: 1 day
Intraoperative Blood Loss
Blood loss during index surgery for rectal cancer in millilitres
Measured: 1 day
Intraoperative Adverse Events
Review of surgical dictation for any deviation from expected intraoperative processes
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start1 Aug 2022
- Primary completion1 Mar 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a single center, single-arm prospective cohort pilot study.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04379830
- Sponsor's protocol ID
- 8246
- Status last verified
- Jan 2024
- First submitted
- 30 Apr 2020
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Very Low Energy Diet on Mesorectal Volume in Rectal Cancer Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT04379830
- Acronym / sponsor ID
- 8246
- Conditions
- Rectal Cancer, Obesity
- Keywords
- Very Low Energy Diet, Low Anterior Resection, Laparoscopy, Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 8 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a single center, single-arm prospective cohort pilot study.
| Arm | Type | Receives |
|---|---|---|
| Very Low Energy Diet | Experimental | Dietary Supplement: Very Low Energy DietVLED 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Very Low Energy DietAlso: Optifast 900Optifast 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. | Dietary supplement | Very Low Energy Diet |
Primary outcome
Recruitment Target (trial feasibility)
Time frame: 6 months
20 patients over 6 months (3.33 patients per month)
Medication Compliance Rate (trial feasibility)
Time frame: 6 months
Percentage of participants adhering to prescribed Optifast 900 dosages and percentage of Optifast 900 dosages missed by study participants
Follow-Up Rate (trial feasibility)
Time frame: 6 months
Percentage of participants completing follow up appointments, questionnaires, and investigations
Incidence of Treatment-Emergent Adverse Events (safety and tolerability)
Time frame: 2 months
Change in functional independence from the preoperative, pre-VLED period to 1-month postoperatively using the World Health Organization Disability Assessment Schedule 2.0
Change in Mesorectal Fat Volume (efficacy)
Time frame: 1 month
Change in mesolectal fat volume on MRI from prior to 3 weeks of preoperative VLED to immediately following completion of preoperative VLED
6 secondary outcomes
Cost
Time frame: 6 months
Postoperative Length of Stay
Time frame: 1 month
Postoperative Adverse Events
Time frame: 1 month
Operative Time
Time frame: 1 day
Intraoperative Blood Loss
Time frame: 1 day
Intraoperative Adverse Events
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Very Low Energy Diet in people with Rectal Cancer and Obesity, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Target (trial feasibility) (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.