A Prospective, Multicenter, Randomized, Parallel-controlled, Superiority Trial
270 participantsStarted 2026-05-30
Plain-language summary
This study intends to design and conduct a prospective, multicenter, randomized, parallel-controlled, superiority trial to evaluate the symptom-relieving effects of Shouhui Tongbian Capsule on opioid-induced constipation (OIC) in cancer patients, including defecation frequency, stool consistency, symptom scores, quality of life and other indicators, and to systematically observe its safety in clinical application. Through analysis of intestinal flora, the mechanism of Shouhui Tongbian Capsule in regulating intestinal function will be revealed. By screening the optimal population for Shouhui Tongbian Capsule in the treatment of OIC, evidence will be provided for optimizing individualized medication.
The primary efficacy endpoint is the proportion of responders at week 2 of treatment, defined as an increase of ā„1 in the average weekly number of spontaneous bowel movements (SBMs) compared with baseline and at least one SBM during that week. Secondary endpoints include weekly number of SBMs, weekly number of complete spontaneous bowel movements (CSBMs), Bristol Stool Form Scale score, straining score, Patient Assessment of Constipation-Symptoms (PAC-SYM) score, and Patient Assessment of Constipation-Quality of Life (PAC-QOL) score.
Safety endpoints mainly include the incidence of adverse events and changes in vital signs, electrocardiography, routine blood and urine tests, as well as liver and renal function before and after treatment. Meanwhile, based on clinical study data, the characteristics of the optimal population for Shouhui Tongbian Capsule in treating OIC will be identified to further enrich the application scenarios of this capsule for OIC.
Who can participate
Age range18 Years ā 85 Years
SexALL
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Inclusion criteria
ā. Must meet the diagnostic criteria for \*\*opioid-induced constipation (OIC) according to the Rome IV Criteria\*\*.
ā. Patients enrolled in the trial must have a history of OIC symptoms for at least 1 week.
ā. Patients must be aged ā„ 18 years and ā¤ 85 years.
ā. Patients must have stable cancer status with a life expectancy of more than 6 months.
ā. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
ā. Patients must be on a relatively stable maintenance regimen of opioids, including a daily morphine-equivalent dose of 30 mg to 1000 mg for at least 2 weeks prior to the screening period. In addition, opioid therapy is expected to continue for at least 10 weeks.
ā. Patients must have a spontaneous bowel movement (SBM) frequency of ā¤ 2 times per week without laxative use.
ā. Patients must be able to take medications, food, and fluids orally.
Exclusion criteria
What they're measuring
1
SBM
Timeframe: 2 weeks
Trial details
NCT IDNCT07534995
SponsorFirst Teaching Hospital of Tianjin University of Traditional Chinese Medicine
. Patients diagnosed with clinically significant defecation disorders at enrollment caused by structural abnormalities of the gastrointestinal tract and other gastrointestinal-related tissues (excluding OIC): inflammatory bowel disease, rectal prolapse, gastrointestinal obstruction, peritoneal metastasis or peritoneal tumors.
ā. Patients with a history of gastrointestinal surgery, abdominal surgery or abdominal adhesions within 1 month before screening; or a history of intestinal obstruction within 3 months before screening.
ā. Diagnosis of active diverticular disease; or severe hemorrhoids; or anal fissure; or artificial rectum or anus.
ā. Patients with intra-abdominal catheters or feeding tubes.
ā. Diagnosis of pelvic diseases considered to significantly affect intestinal transit of feces (e.g., uterine prolapse ā„ grade 2, uterine fibroids \[located posteriorly with diameter ā„ 5 cm\] affecting defecation).
ā. Patients who received a new chemotherapy regimen never used before within 14 days after screening, or who planned to receive such treatment during the study period.
ā. Patients who received radiotherapy within 28 days after screening or planned to receive such treatment during the study period.
ā. Patients who underwent surgery or intervention considered to significantly affect gastrointestinal function within 28 days after screening, or planned to undergo such surgery or intervention during the study period, or planned to undergo surgery or intervention expected to prevent completion of the trial.