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)

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Constipation; Functional Constipation
• Intervention / Treatment: Dietary supplement: MZRW

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jun Mao, MD, MSCE; Phone Number: 646-608-8552; Email: maoj@mskcc.org
• Study Contact Backup: Name: Yen Nien (Jason) Hou, PharmD; Phone Number: 646-608-8555; Email: houy@mskcc.org

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Recruiting
      • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
      • Contact: Jun Mao, MD, MSCE; Phone Number: 646-608-8552
    • Middletown, New Jersey, United States, 07748
      • Recruiting
      • Memorial Sloan Kettering Monmouth (All Protocol Activities)
      • Contact: Jun Mao, MD, MSCE; Phone Number: 646-608-8552
    • Montvale, New Jersey, United States, 07645
      • Recruiting
      • Memorial Sloan Kettering Bergen (All Protocol Activities)
      • Contact: Jun Mao, MD, MSCE; Phone Number: 646-608-8552
  • New York
    • Commack, New York, United States, 11725
      • Recruiting
      • Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
      • Contact: Jun Mao, MD, MSCE; Phone Number: 646-608-8553
    • Harrison, New York, United States, 10604
      • Recruiting
      • Memorial Sloan Kettering Westchester (All protocol activities)
      • Contact: Jun Mao, MD, MSCE; Phone Number: 646-608-8552
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
      • Contact: Jun Mao, MD, MSCE; Phone Number: 646-608-8552
    • Rockville Centre, New York, United States, 11553
      • Recruiting
      • Memorial Sloan Kettering Nassau (All Protocol Activities)
      • Contact: Jun Mao, MD, MSCE; Phone Number: 646-608-8552

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 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 contraception by patient report.Patient's should follow proper contraception guidelines for at least 30 days following last dose of the study drug.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MZRW; Participants will receive 2 weeks of MZRW	Dietary supplement: MZRW; 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; Other Names: Ma-Zi-Ren-Wan
No Intervention: Placebo; Participants will receive 2 weeks of placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Jun Mao, MD, MSCE, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2025
• Primary Completion (Estimated): July 15, 2028
• Study Completion (Estimated): July 15, 2028

Study Registration Dates

• First Submitted: July 15, 2025
• First Submitted That Met QC Criteria: July 21, 2025
• First Posted (Actual): July 29, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Memorial Sloan Kettering Cancer Center; constipation; functional constipation; Ma-Zi-Ren-Wan; MZRW; 25-076
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neoplasms; Constipation; ma zi ren wan
• Other Study ID Numbers: 25-076

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: • 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No