A Study of Herbal Supplements in Cancer Survivors With Constipation

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Jul 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a herbal supplement called MZRW can help treat constipation in people who have survived cancer. Constipation can be a common problem after cancer treatment, and this study aims to see if MZRW works better than a placebo—a pill that looks the same but doesn’t contain any active medicine. The researchers will also look at how MZRW might affect the gut microbiome, which is the community of good bacteria and other tiny organisms in your digestive system that help with digestion and your immune health.

People eligible for this study must be adults (18 years or older) who have had cancer and finished their main treatments like surgery, chemotherapy, or radiation at least one month ago. They should have ongoing constipation symptoms that meet specific criteria, such as straining during bowel movements, hard stools, or fewer than three bowel movements a week. Participants need to be able to understand and complete study tasks on their own and give informed consent in English. If you join, you will take either MZRW or a placebo pill and be monitored to see how your constipation symptoms and gut health change. This study is still recruiting, so if you or a loved one fits the criteria, it might be worth discussing with your healthcare provider.

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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)
• • 8. 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
• • 10. 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 between 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.