NCT07091084招募中不适用
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)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 14
- 主要终点
- Difference of spontaneous bowel movements (SBMs) from baseline to week 2
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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.
- •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
- •Insufficient criteria for irritable bowel syndrome Note *Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
排除标准
- •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, and prior abdominal radiation therapy;
- •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.
研究组 & 干预措施
Placebo
No Intervention
Participants will receive 2 weeks of placebo
MZRW
Experimental
Participants will receive 2 weeks of MZRW
干预措施: MZRW (Dietary Supplement)
结局指标
主要结局
Difference of spontaneous bowel movements (SBMs) from baseline to week 2
时间窗: 2 weeks
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.
次要结局
未报告次要终点
研究者
研究点 (14)
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