NCT07091084

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
27mo left

Started Jul 2025

Typical duration for not_applicable

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Jul 2025Jul 2028

First Submitted

Initial submission to the registry

July 15, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

July 15, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 29, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2028

Last Updated

December 4, 2025

Status Verified

December 1, 2025

Enrollment Period

3 years

First QC Date

July 15, 2025

Last Update Submit

December 3, 2025

Conditions

ConstipationCancerFunctional Constipation

Keywords

constipationfunctional constipationMa-Zi-Ren-WanMZRW25-076Memorial Sloan Kettering Cancer Center

Outcome Measures

Primary Outcomes (1)

  • Difference of spontaneous bowel movements (SBMs) from baseline to week 2

    To evaluate the efficacy of a 2-week regimen of oral MZRW vs. placebo on spontaneous bowel movements (SBMs), in terms of SBM therapeutic response (primary efficacy endpoint), among cancer survivors with chronic constipation. SBM response is defined at week 2 as having an increase of ≥ 1 SBM/week from baseline.

    2 weeks

Study Arms (2)

MZRW

EXPERIMENTAL

Participants will receive 2 weeks of MZRW

Dietary Supplement: MZRW

Placebo

NO INTERVENTION

Participants will receive 2 weeks of placebo

Interventions

MZRWDIETARY_SUPPLEMENT

MZRW herbal formula consists of a 7:1 extract of Huo Ma Ren \[Hemp Seed 33.4%\]; Da Huang (Sheng) \[Rhubarb (Fresh) 22.2%\]; Bai Shao \[Peony (White) 11.1%\]; Zhi Shi \[Aurantium Immaturus 11.1%\]; Hou Po \[Magnolia Bark 11.1%\]; and Xing Ren \[Apricot Kernel 11.1%\] - Taken for 2 weeks intervention and 2 weeks follow-up

Also known as: Ma-Zi-Ren-Wan
MZRW

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • +9 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (All Protocol Activities)

Rockville Centre, New York, 11553, United States

RECRUITING

Related Links

MeSH Terms

Conditions

ConstipationNeoplasms

Interventions

ma zi ren wan

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jun Mao, MD, MSCE

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Mao, MD, MSCE

CONTACT

646-608-8552maoj@mskcc.org

Yen Nien (Jason) Hou, PharmD

CONTACT

646-608-8555houy@mskcc.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2025

First Posted

July 29, 2025

Study Start

July 15, 2025

Primary Completion (Estimated)

July 15, 2028

Study Completion (Estimated)

July 15, 2028

Last Updated

December 4, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

• Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Locations

US(7)