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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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.

Where it's running

• Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth (All Protocol Activities)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Bergen (All Protocol Activities)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Westchester (All Protocol Activities)
  Harrison, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center (All Protocol Activities)
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Jun Mao, MD, MSCE — Memorial Sloan Kettering Cancer Center
• Study coordinator: Jun Mao, MD, MSCE
• Email: maoj@mskcc.org
• Phone: 646-608-8552

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.