Actively Recruiting
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)
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-22
70
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the herbal formula Ma-Zi-Ren-Wan (MZRW) as a treatment for constipation in cancer survivors. This study aims to compare MZRW with a placebo to see if it improves bowel movements and to study its effect on the gut microbiome, which is important for digestion and immune health. The trial is a double-blinded, randomized controlled study led by Memorial Sloan Kettering Cancer Center. Participants will receive either MZRW or a placebo pill for 2 weeks. MZRW contains extracts from several herbs, including hemp seed, fresh rhubarb, white peony, aurantium immaturus, magnolia bark, and apricot kernel. After the 2-week treatment period, participants will be followed for an additional 2 weeks. The study compares the number of spontaneous bowel movements from the start to the end of the 2-week treatment. During the study, participants will complete assessments related to their bowel movements and symptoms of constipation. Researchers will monitor changes in spontaneous bowel movements as the main outcome. The study includes a baseline period, a 2-week treatment phase, and a 2-week follow-up. Participants will provide informed consent and complete all study assessments independently in English. The total participation lasts around 4 weeks, including treatment and follow-up.
CONDITIONS
Brief Title
A Study of Herbal Supplements in Cancer Survivors With Constipation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or greater
- Diagnosis of cancer with no restrictions on cancer type or stage
- Completed surgery, chemotherapy, immunotherapy, radiotherapy, or investigational therapy at least 1 month prior; stable hormone or targeted therapies allowed
- Karnofsky functional score of 60 or higher
- Cancer survivors meeting Rome IV criteria for functional constipation, including two or more specific bowel symptoms
- Ability to understand and complete all study assessments independently
- Ability to provide signed informed consent in English
You will not qualify if you...
- Allergy to herbs or Chinese medicine
- Significant liver abnormalities (ALT or AST over twice the normal limit) or kidney dysfunction (eGFR below 59 mL/min/1.73m²) based on recent tests
- Signs or high risk of bowel obstruction, including factors like tumor invasion, recent surgery, or prior radiation
- Use of opioid antagonists for opioid-induced constipation that cannot be stopped
- Women who are pregnant, breastfeeding, or not using proper contraception; contraception required for at least 30 days after last study dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants take the MZRW herbal supplement or placebo for 2 weeks to evaluate effects on bowel movement function.
1 baseline visit and 1 follow-up visit
Duration - 2 weeks
Participants are monitored for 2 weeks after treatment to assess ongoing effects and safety.
1 visit
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (All Protocol Activities)
Rockville Centre, New York, United States, 11553
Actively Recruiting
Research Team
J
Jun Mao, MD, MSCE
Y
Yen Nien (Jason) Hou, PharmD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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