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RECRUITINGNA

A Study of Herbal Supplements in Cancer Survivors With Constipation

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)

NCT07091084•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion 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.
+14 more criteria

Exclusion Criteria

•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 below 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.

Locations (7)

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (All Protocol Activities)

Rockville Centre, New York, United States

Key Dates

Start Date

July 15, 2025

Primary Completion Date

July 15, 2028

Completion Date

July 15, 2028

Last Updated

December 4, 2025

Enrollment

ESTIMATED participants

Conditions

ConstipationCancerFunctional Constipation

Interventions

MZRW

DIETARY_SUPPLEMENT

Contacts

Jun Mao, MD, MSCE

CONTACT

646-608-8552 maoj@mskcc.org

Yen Nien (Jason) Hou, PharmD

CONTACT

646-608-8555 houy@mskcc.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Herbal Supplements in Cancer Survivors With Constipation

Inclusion Criteria

Exclusion Criteria

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