ClinicalTrials.gg
RecruitingNCT07091084Updated May 22, 2026

A Study of Herbal Supplements in Cancer Survivors With Constipation

An interventional study of MZRW in Constipation, Cancer and Functional Constipation, sponsored by Memorial Sloan Kettering Cancer Center. Recruiting at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by Memorial Sloan Kettering Cancer Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Constipation
  • Cancer
  • Functional Constipation

Keywords

  • constipation
  • functional constipation
  • Ma-Zi-Ren-Wan
  • MZRW
  • 25-076
  • Memorial Sloan Kettering Cancer Center
03

In context

Constipation

1,046 studies on the registry are indexed under Constipation; 161 are open to participants now.

This study's planned enrollment of 70 is close to the median of 75 across 884 interventional studies indexed under Constipation.

Browse Constipation studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,964 studies on the registry; 327 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 71 (53%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 therapy at least one month prior to study initiation. Patients on stable doses of hormone therapy or targeted therapies will not be excluded;
  • 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 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

Exclusion Criteria:

  • Patients who have allergic history to herbs or Chinese medicine;
  • abnormal liver (2 times the for or AST) and kidney disfunction( below 59 mL/min/1.73m² ) from recent laboratory test recorded in the medical record (within 2 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 by patient report.Patient's should follow proper contraception guidelines for at least 30 days following last dose of the study drug.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    MZRW

    Participants will receive 2 weeks of MZRW

    Dietary Supplement: MZRW

  • No intervention
    Placebo

    Participants will receive 2 weeks of placebo

Interventions

  • Dietary supplementMZRW

    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

06

What researchers measure

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.

    Time frame: 2 weeks

07

Study locations

7 of 7 sites recruiting
  • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
    Basking Ridge, New Jersey 07920, United States
    Recruiting
    • Jun Mao, MD, MSCE · Contact646-608-8552
  • Memorial Sloan Kettering Monmouth (All Protocol Activities)
    Middletown, New Jersey 07748, United States
    Recruiting
    • Jun Mao, MD, MSCE · Contact646-608-8552
  • Memorial Sloan Kettering Bergen (All Protocol Activities)
    Montvale, New Jersey 07645, United States
    Recruiting
    • Jun Mao, MD, MSCE · Contact646-608-8552
  • Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
    Commack, New York 11725, United States
    Recruiting
    • Jun Mao, MD, MSCE · Contact646-608-8553
  • Memorial Sloan Kettering Westchester (All Protocol Activities)
    Harrison, New York 10604, United States
    Recruiting
    • Jun Mao, MD, MSCE · Contact646-608-8552
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
    New York, New York 10065, United States
    Recruiting
    • Jun Mao, MD, MSCE · Contact646-608-8552
  • Memorial Sloan Kettering Nassau (All Protocol Activities)
    Rockville Centre, New York 11553, United States
    Recruiting
    • Jun Mao, MD, MSCE · Contact646-608-8552
08

References and documents

Individual participant data

Plan to share: Yes — 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07091084
Responsible party
Sponsor
First posted
Jul 29, 2025
Start date
Jul 15, 2025
Primary completion
Jul 15, 2028 (estimated)
Completion
Jul 15, 2028 (estimated)
Last update
May 22, 2026

Study contacts

Jun Mao, MD, MSCE
Contact
maoj@mskcc.org
646-608-8552
Yen Nien (Jason) Hou, PharmD
Contact
houy@mskcc.org
646-608-8555
Jun Mao, MD, MSCE
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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