Bowel Management Program for Colorectal Cancer

Overseen By The Ohio State Comprehensive Cancer Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Colorectal cancer, Recent surgery, Chemo, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 52 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist individuals with low anterior resection syndrome (LARS), a condition that can cause frequent or urgent bowel movements and constipation after rectal cancer surgery. The study compares two approaches: a combination of a bowel management program with a retrograde rectal enema (a method to empty the bowels) and standard medical management, which includes fiber supplements, medications, and pelvic floor exercises. Individuals who have undergone rectal cancer surgery and now experience LARS might be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to investigate innovative treatments for LARS.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. It might be best to discuss this with the research team or your doctor.

What prior data suggests that this bowel management program with retrograde rectal enema is safe for patients with low anterior resection syndrome?

Research has shown that retrograde rectal enemas (RRE) can help manage symptoms of low anterior resection syndrome (LARS), a condition often occurring after rectal cancer surgery. Studies have found that RRE reduces symptoms like sudden bowel movements and incontinence, leading to an improved LARS score.

RRE has been well-received, with no major safety issues reported in studies. While some individuals might experience mild discomfort during the procedure, serious side effects are rare. This suggests that RRE is a safe option for managing LARS symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a comprehensive bowel management program that includes a unique approach using retrograde rectal enemas (RRE). Unlike standard treatments for colorectal cancer-related bowel issues, which typically involve medications like fiber and loperamide or surgical options like sacral nerve stimulation, this program combines medical management with a self-administered enema regimen. The RRE offers a new delivery method that allows patients to tailor their treatment to their individual needs, potentially enhancing comfort and effectiveness. By incorporating pelvic floor physical therapy alongside RRE, the trial aims to improve bowel control and quality of life significantly for patients.

What evidence suggests that this bowel management program with retrograde rectal enema is effective for low anterior resection syndrome?

Research has shown that a retrograde rectal enema (RRE) can help manage low anterior resection syndrome (LARS) in individuals who have had rectal cancer. Studies have found that RRE reduces LARS symptoms such as urgency, loss of bowel control, and constipation. In this trial, participants in Group I will follow a bowel management program that includes RRE along with medical treatments like fiber supplements, loperamide hydrochloride (a medication to reduce diarrhea), and pelvic floor exercises. Participants in Group II will receive only the medical treatments. Patients who used RRE reported better symptom control compared to those who only used medical treatments. Overall, RRE appears to be a promising method for improving bowel function after rectal surgery. ^{1 2 4 5 6}

Who Is on the Research Team?

Alessandra C Gasior, DO

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for rectal cancer patients who have undergone a low anterior resection and are now experiencing LARS, which includes symptoms like fecal urgency, incontinence, constipation, or difficulty emptying the bowel. The study seeks individuals struggling with these post-surgery changes to their bowel habits.

Inclusion Criteria

I have been diagnosed with LARS.

I have a history of rectal cancer.

Exclusion Criteria

My colorectal cancer has come back.

Active sacral nerve simulator

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a bowel management program with either RRE and medical management or medical management alone for 1 year

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Follow-up visits at 1 month, 3 months, and 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Retrograde Rectal Enema

Trial Overview The study is testing if a bowel management program using retrograde rectal enemas (RRE) can better manage LARS symptoms compared to standard medical treatments alone. This involves inserting a catheter into the rectum to help with fecal emptying alongside dietary adjustments, medication like loperamide hydrochloride, and physical therapy.

How Is the Trial Designed?

Group I: Group I (RRE, medical management) Experimental Treatment 6 Interventions

Patients undergo a bowel management program comprising a medical management pathway (fiber, loperamide hydrochloride, pelvic floor physical therapy) in combination with RRE treatment for 1 year. Patients use the RRE system to self administer an individualized enema regimen via the rectum. Patients may undergo abdominal film x-rays throughout the trial.

Group II: Group II (medical management) Active Control 4 Interventions

Patients receive medical management comprising fiber, loperamide hydrochloride, and pelvic floor therapy for 1 year. If medical management fails, patients may then be referred for surgery with sacral nerve stimulator placement.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Published Research Related to This Trial

In a study of 46,692 elderly colorectal cancer patients, those receiving intravenous chemotherapy experienced significantly higher rates of adverse events, particularly with oxaliplatin-based regimens, which caused more nausea, neutropenia, and neuropathy compared to fluorouracil alone.

Patients aged 70 and older were more likely to suffer from adverse effects such as infection, anemia, delirium, and heart disease, highlighting the need for careful patient selection and support when administering chemotherapy to older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of toxicity profiles of fluorouracil versus oxaliplatin regimens in a large population-based cohort of elderly patients with colorectal cancer. Cen, P., Liu, C., Du, XL.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12102822/

The efficacy of retrograde and antegrade enemas in ... According to our findings, enema, particularly retrograde enema, is effective in managing LARS and can lower the LARS score. However, the ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06424522/a-bowel-management-program-retrograde-rectal-enema-for-the-treatment-of-low-anterior-resection-syndrome-in-rectal-cancer-patients

A Bowel Management Program (Retrograde Rectal Enema ... Participating in a bowel management program with a RRE may be more effective in treating LARS than medical management alone. ... Patients with ...

3. withpower.com withpower.com/trial/early-phase-1-syndrome-9-2024-6d81b

Bowel Management Program for Colorectal Cancer ... Retrograde Rectal Enema will have tolerable side effects & efficacy for patients with Rectal Cancer, Anterior Resection Syndrome and Colorectal Cancer. See

4. researchgate.net researchgate.net/publication/392021529_The_efficacy_of_retrograde_and_antegrade_enemas_in_the_management_of_low_anterior_resection_syndrome_in_patients_undergoing_rectal_resection_a_systematic_review_and_meta-analysis

(PDF) The efficacy of retrograde and antegrade enemas in ... Subgroup analysis based on the type of enema were performed, with three European studies using retrograde enema and one Asian study using ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06717854?term=AREA%5BConditionSearch%5D((vohwinkel%20syndrome%20variants%20from)%20OR%20(lar))&rank=2

Retrograde and Antegrade Enema for Prevention of LARS ... To compare the effects and advantages and disadvantages of antegrade and retrograde enema, and to investigate whether these two types of enema can provide safe ...

6. app.trialscreen.org app.trialscreen.org/trials/early-phase-1-bowel-management-program-retrograde-rectal-enema-treatment-trial-nct06424522

A Bowel Management Program (Retrograde Rectal Enema ... This Interventional study is looking for people with Low Anterior Resection Syndrome, Rectal Carcinoma in Columbus United States to take part.