A Study of Herbal Supplements in Cancer Survivors With Constipation

NCT ID: NCT07091084

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-15
• Study Completion Date: 2028-07-15

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.

Conditions

Constipation; Cancer; Functional Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MZRW

Participants will receive 2 weeks of MZRW

Group Type: EXPERIMENTAL

MZRW

Intervention Type: DIETARY_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

Placebo

Participants will receive 2 weeks of placebo

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Ma-Zi-Ren-Wan

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jun Mao, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, United States

Site Status: RECRUITING

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, United States

Site Status: RECRUITING

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, United States

Site Status: RECRUITING

Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)

Commack, New York, United States

Site Status: RECRUITING

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, United States

Site Status: RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Site Status: RECRUITING

Memorial Sloan Kettering Nassau (All Protocol Activities)

Rockville Centre, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jun Mao, MD, MSCE

Role: CONTACT

maoj@mskcc.org

646-608-8552

Yen Nien (Jason) Hou, PharmD

Role: CONTACT

houy@mskcc.org

646-608-8555

Facility Contacts

Jun Mao, MD, MSCE

Role: primary

646-608-8552

Jun Mao, MD, MSCE

Role: primary

646-608-8552

Jun Mao, MD, MSCE

Role: primary

646-608-8552

Jun Mao, MD, MSCE

Role: primary

646-608-8553

Jun Mao, MD, MSCE

Role: primary

646-608-8552

Jun Mao, MD, MSCE

Role: primary

646-608-8552

Jun Mao, MD, MSCE

Role: primary

646-608-8552

Related Links

http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

25-076

Identifier Type: -

Identifier Source: org_study_id