RECRUITING

A Study of Herbal Supplements in Cancer Survivors With Constipation

Conditions

Constipation Cancer Functional Constipation Ma-Zi-Ren-Wan MZRW 25-076 Memorial Sloan Kettering Cancer Center

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to find out whether MZRW is an effective treatment for constipation in cancer survivors. The researchers will compare MZRW with placebo, a pill that looks like MZRW and is given in the same way, but contains no medication. The researchers will also study the effect MZRW has on the gut microbiome. The gut microbiome is a diverse community of microorganisms living in the digestive system, essential for digestion and immune function.

Official Title

Herbal Formula Ma-Zi-Ren-Wan (MZRW) on Bowel Movement Function and Gut Microbiome Among Cancer Survivors With Constipation: A Double-blinded Randomized Controlled Trial (RELIEVE)

Quick Facts

Study Start:2025-07-15

Study Completion:2028-07-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07091084

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age 18 years or greater; * A diagnosis of cancer with no restrictions placed on type of cancer or stage; * Completed surgery, chemotherapy, immunotherapy, and/or radiotherapy, or an investigational therapy at least one month prior to study initiation. Patients on stable doses of hormone therapy or targeted therapies will not be excluded; * Karnofsky functional score of ≥ 60; * Cancer survivors who have met the Rome IV criteria (Table 3) of the symptoms of functional constipation which must include two or more of the following: * Straining more than 25% of defecations. * Lumpy or hard stools (7-point Bristol stool scale 1 or 2) more than 25% of defecations. * Sensation of incomplete evacuation more than one-fourth (25%) of defecations. * Sensation of anorectal obstruction/blockage more than one-fourth (25%) of defecations. * Manual maneuvers to facilitate more than one-fourth (25%) of defecations. * Fewer than three spontaneous bowel movements per week. * Loose stools are rarely present without the use of laxatives. * Insufficient criteria for irritable bowel syndrome. * Patient should be able to understand and complete all study assessments on their own * Patient should be able to understand and provide signed informed consent in English. 1. Must include two or more of the following:\\ 2. Straining during more than ¼ (25%) of defecations 3. Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than ¼ (25%) of defecations 4. Sensation of incomplete evacuation more than ¼ (25%) of defecations 5. Sensation of anorectal obstruction/blockage more than ¼ (25%) of defecations 6. Fewer than three SBM per week 7. Manual maneuvers to facilitate more than ¼ (25%) of defecations (e.g., digital evacuation, support of the pelvic floor) 8. Manual maneuvers to facilitate more than ¼ (25%) of defecations (e.g., digital evacuation, support of the pelvic floor) 9. Loose stools are rarely present without the use of laxatives 10. Insufficient criteria for irritable bowel syndrome Note \*Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis	* Patients who have allergic history to herbs or Chinese medicine; * Clinically significant abnormal liver (2 times the ULN for ALT or AST) and kidney disfunction(eGFR between 59 mL/min/1.73m² ) from recent laboratory test recorded in the medical record (within 1 month); * Patients who have any signs of bowel obstruction, or have high risk of bowel obstruction assessed by their treating physician, including factors such as tumor invasion into abdominal organs, recent abdominal surgery, and prior abdominal radiation therapy; * Patients who are prescribed opioid antagonists including methylnaltrexone, naloxegol and naldemedine for opioid induced constipation and required not to stop the medication; * Women who are pregnant, lactating, or not practicing proper contraception by patient report.Patient's should follow proper contraception guidelines for at least 30 days following last dose of the study drug.

Inclusion Criteria

Exclusion Criteria

* Age 18 years or greater;
* A diagnosis of cancer with no restrictions placed on type of cancer or stage;
* Completed surgery, chemotherapy, immunotherapy, and/or radiotherapy, or an investigational therapy at least one month prior to study initiation. Patients on stable doses of hormone therapy or targeted therapies will not be excluded;
* Karnofsky functional score of ≥ 60;
* Cancer survivors who have met the Rome IV criteria (Table 3) of the symptoms of functional constipation which must include two or more of the following:
* Straining more than 25% of defecations.
* Lumpy or hard stools (7-point Bristol stool scale 1 or 2) more than 25% of defecations.
* Sensation of incomplete evacuation more than one-fourth (25%) of defecations.
* Sensation of anorectal obstruction/blockage more than one-fourth (25%) of defecations.
* Manual maneuvers to facilitate more than one-fourth (25%) of defecations.
* Fewer than three spontaneous bowel movements per week.
* Loose stools are rarely present without the use of laxatives.
* Insufficient criteria for irritable bowel syndrome.
* Patient should be able to understand and complete all study assessments on their own
* Patient should be able to understand and provide signed informed consent in English.
1. Must include two or more of the following:\*\*
2. Straining during more than ¼ (25%) of defecations
3. Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than ¼ (25%) of defecations
4. Sensation of incomplete evacuation more than ¼ (25%) of defecations
5. Sensation of anorectal obstruction/blockage more than ¼ (25%) of defecations
6. Fewer than three SBM per week
7. Manual maneuvers to facilitate more than ¼ (25%) of defecations (e.g., digital evacuation, support of the pelvic floor)
8. Manual maneuvers to facilitate more than ¼ (25%) of defecations (e.g., digital evacuation, support of the pelvic floor)
9. Loose stools are rarely present without the use of laxatives
10. Insufficient criteria for irritable bowel syndrome Note \*Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis

* Patients who have allergic history to herbs or Chinese medicine;
* Clinically significant abnormal liver (2 times the ULN for ALT or AST) and kidney disfunction(eGFR between 59 mL/min/1.73m² ) from recent laboratory test recorded in the medical record (within 1 month);
* Patients who have any signs of bowel obstruction, or have high risk of bowel obstruction assessed by their treating physician, including factors such as tumor invasion into abdominal organs, recent abdominal surgery, and prior abdominal radiation therapy;
* Patients who are prescribed opioid antagonists including methylnaltrexone, naloxegol and naldemedine for opioid induced constipation and required not to stop the medication;
* Women who are pregnant, lactating, or not practicing proper contraception by patient report.Patient's should follow proper contraception guidelines for at least 30 days following last dose of the study drug.

Contacts and Locations

Study Contact

Jun Mao, MD, MSCE

CONTACT

646-608-8552

maoj@mskcc.org

Yen Nien (Jason) Hou, PharmD

CONTACT

646-608-8555

houy@mskcc.org

Principal Investigator

Jun Mao, MD, MSCE

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, 07645

United States

Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

United States

Memorial Sloan Kettering Nassau (All Protocol Activities)

Rockville Centre, New York, 11553

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Jun Mao, MD, MSCE, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-15

Study Completion Date2028-07-15

Study Record Updates

Study Start Date2025-07-15

Study Completion Date2028-07-15

Terms related to this study

Keywords Provided by Researchers

constipation
functional constipation
Ma-Zi-Ren-Wan
MZRW
25-076
Memorial Sloan Kettering Cancer Center

Additional Relevant MeSH Terms

Constipation
Cancer
Functional Constipation