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)
Memorial Sloan Kettering Cancer Center
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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.…
Interventions
- Dietary SupplementMZRW
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
Locations (7)
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities)Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (All Protocol Activities)Middletown, New Jersey
- Memorial Sloan Kettering Bergen (All Protocol Activities)Montvale, New Jersey
- Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)Commack, New York
- Memorial Sloan Kettering Westchester (All Protocol Activities)Harrison, New York
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)New York, New York