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Ma-Zi-Ren-Wan (MZRW) herbal treatment for constipation in cancer survivors

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)

Not applicable Interventional Memorial Sloan Kettering Cancer Center · NCT07091084

This will see if the herbal formula Ma-Zi-Ren-Wan (MZRW) helps relieve functional constipation in adult cancer survivors compared with a placebo.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment70 (estimated)
Ages18 Years and up
SexAll
SponsorMemorial Sloan Kettering Cancer Center Academic / other
Drugs / interventionschemotherapy, immunotherapy, radiation
Locations7 sites (Basking Ridge, New Jersey and 6 other locations)
Trial IDNCT07091084 on ClinicalTrials.gov

What this trial studies

This is a randomized, placebo-controlled interventional study comparing the herbal formula Ma-Zi-Ren-Wan (MZRW) to a matched placebo in adult cancer survivors who meet Rome IV criteria for functional constipation. Participants must be at least 18 years old, have completed major cancer treatments at least one month prior (except stable hormone or targeted therapies), and have a Karnofsky score ≥ 60. The study measures bowel symptoms and will analyze changes in the gut microbiome to explore biological effects of MZRW. Study activities take place at three Memorial Sloan Kettering locations in New Jersey.

Who should consider this trial

Good fit: Adult cancer survivors (age ≥18) with functional constipation by Rome IV criteria who completed surgery/chemotherapy/radiotherapy/immunotherapy or investigational therapy at least one month ago and have a Karnofsky score of 60 or higher.

Not a fit: Patients with constipation from a mechanical bowel obstruction, those still receiving recent active cancer therapy within the past month, with Karnofsky <60, or whose symptoms do not meet Rome IV functional constipation criteria are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If effective, MZRW could offer a tolerated herbal option to improve bowel frequency and stool consistency for cancer survivors with functional constipation.

How similar studies have performed: Small studies in non-cancer populations with functional constipation have suggested MZRW may improve bowel symptoms, but high-quality evidence is limited and its use in cancer survivors is relatively untested.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.
  * 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.

Table 3. Rome IV criteria for functional constipation FUNCTIONAL CONSTIPATION Diagnostic criteria\*

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)

9\. Loose stools are rarely present without the use of laxatives 9. Insufficient criteria for irritable bowel syndrome Note \*Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis

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.

Where this trial is running

Basking Ridge, New Jersey and 6 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions ConstipationCancerFunctional Constipationconstipationfunctional constipationMa-Zi-Ren-WanMZRW25-076
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.