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A Study of Herbal Supplements in Cancer Survivors with Constipation, RELIEVE Trial
Trial Status: active
This phase II trial evaluates the effectiveness of an herbal supplement called Ma-Zi-Ren-Wan (MZRW), compared to a placebo, for improving constipation in cancer survivors. MZRW is made up of different herbs. These herbs may decrease the levels of oleamide in the body. Oleamide is a signaling molecule that helps control how food moves through the intestines. By lowering levels of this molecule, MZRW may help food move through the colon more easily, which may help reduce constipation.
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 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
Note: Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
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
Exclusion Criteria
Patients who have allergic history to herbs or Chinese medicine
Clinically significant abnormal liver (2 times the upper limit of normal [ULN] for alanine aminotransferase [ALT] or aspartate aminotransferase [AST]) and kidney dysfunction (estimated glomerular filtration rate [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 methylnatrexone, 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
Additional locations may be listed on ClinicalTrials.gov for NCT07091084.
Locations matching your search criteria
United States
New Jersey
Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: Active
Contact: Jun J. Mao
Phone: 646-608-8552
Middletown
Memorial Sloan Kettering Monmouth
Status: Active
Contact: Jun J. Mao
Phone: 646-608-8552
Montvale
Memorial Sloan Kettering Bergen
Status: Active
Contact: Jun J. Mao
Phone: 646-608-8552
New York
Commack
Memorial Sloan Kettering Commack
Status: Active
Contact: Jun J. Mao
Phone: 646-608-8552
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Jun J. Mao
Phone: 646-608-8552
Uniondale
Memorial Sloan Kettering Nassau
Status: Active
Contact: Jun J. Mao
Phone: 646-608-8552
West Harrison
Memorial Sloan Kettering Westchester
Status: Active
Contact: Jun J. Mao
Phone: 646-608-8552
PRIMARY OBJECTIVE:
I. To evaluate the efficacy of a 2-week regimen of oral MZRW versus (vs.) placebo on spontaneous bowel movements (SBMs), in terms of SBM therapeutic response (primary efficacy endpoint), among cancer survivors with chronic constipation.
SECONDARY OBJECTIVE:
I. To explore the effects of MZRW versus placebo on the gut microbiome, in terms of changes from baseline to week 2 and week 4 in gut-microbiome diversity, changes in beneficial and harmful bacteria, and correlations between SBM response and changes in the gut microbiome, among cancer survivors with constipation.
EXPLORATORY OBJECTIVES:
I. To evaluate the durability of SBM response to MZRW during the two weeks after the intervention (i.e., during weeks 3 and 4).
II. To evaluate the influence of dietary and physical activity level on effect of MZRW/placebo on bowel movement function improvement.
III. To evaluate patients’ compliance to the original intervention and its impact on MZRW/placebo’s effect on bowel movement.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive Ma Zi Ren Wan orally (PO) twice daily (BID) for 2 weeks.
ARM II: Patients receive placebo PO BID for 2 weeks.
After completion of study intervention, patients are followed up for 2 weeks.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationMemorial Sloan Kettering Cancer Center
