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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MZRW | Experimental | Participants will receive 2 weeks of MZRW |
|
| Placebo | No Intervention | Participants will receive 2 weeks of placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MZRW | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference of spontaneous bowel movements (SBMs) from baseline to week 2 | To evaluate the efficacy of a 2-week regimen of oral MZRW vs. placebo on spontaneous bowel movements (SBMs), in terms of SBM therapeutic response (primary efficacy endpoint), among cancer survivors with chronic constipation. SBM response is defined at week 2 as having an increase of ≥ 1 SBM/week from baseline. | 2 weeks |
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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:
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*
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Mao, MD, MSCE | Contact | 646-608-8552 | maoj@mskcc.org | |
| Yen Nien (Jason) Hou, PharmD | Contact | 646-608-8555 | houy@mskcc.org |
| Name | Affiliation | Role |
|---|---|---|
| Jun Mao, MD, MSCE | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (All Protocol Activities) | Recruiting | Basking Ridge | New Jersey | 07920 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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• Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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| ID | Term |
|---|---|
| D003248 | Constipation |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000591093 | ma zi ren wan |
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| Memorial Sloan Kettering Monmouth (All Protocol Activities) | Recruiting | Middletown | New Jersey | 07748 | United States |
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| Memorial Sloan Kettering Bergen (All Protocol Activities) | Recruiting | Montvale | New Jersey | 07645 | United States |
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| Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities) | Recruiting | Commack | New York | 11725 | United States |
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| Memorial Sloan Kettering Westchester (All Protocol Activities) | Recruiting | Harrison | New York | 10604 | United States |
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| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | Recruiting | New York | New York | 10065 | United States |
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| Memorial Sloan Kettering Nassau (All Protocol Activities) | Recruiting | Rockville Centre | New York | 11553 | United States |
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