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New treatment option for Constipation
Official title A Study of Herbal Supplements in Cancer Survivors With Constipation
ClinicalTrials.gov ID: NCT07091084
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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 below 59 mL/min/1.73m² ) from recent laboratory...
- Patients who have any signs of bowel obstruction, or have high risk of bowel obstruction assessed by their treating physician, including factors such...
- Patients who are prescribed opioid antagonists including methylnaltrexone, naloxegol and naldemedine for opioid induced constipation and required not...
- Women who are pregnant, lactating, or not practicing proper contraception by patient report.Patient's should follow proper contraception guidelines...
See the full eligibility 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...
- 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\
- Must include two or more of the following:\ \
- Straining during more than ¼ (25%) of defecations
- Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than ¼ (25%) of defecations
- Sensation of incomplete evacuation more than ¼ (25%) of defecations
- Sensation of anorectal obstruction/blockage more than ¼ (25%) of defecations
- Fewer than three SBM per week
- 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 9. Insufficient criteria for...
- 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 below 59 mL/min/1.73m² ) from recent laboratory test recorded in the medical record (within 2 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Rockville Centre, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.