Opioid-related constipation
Conditions
Interventions
Acupuncture group:Acupuncture
Sham Acupuncture group:Sham Acupuncture
Sponsors
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1) Cancer patients must meet the diagnostic criteria of Rome IV Opioid-Related Constipation: (1) Constipation or worsening of constipation symptoms with opioid use or dose change, etc., must include 2 or more of the following: (1) at least 25% of bowel movements are labored; (2) at least 25% of bowel movements are dry ball or hard stools; (3) at least 25% of bowel movements are incomplete; (4) at least 25% of bowel movements have anal rectal obstruction and/or blockage in at least 25% of the bowel movements; (5) at least 25% of the bowel movements required manual assistance (e.g., finger-assisted defecation, pelvic floor support); less than 3 bowel movements per week; (2) the rare occurrence of loose stools when laxatives were not used. 2) Patients recruited for this trial must have at least a 1-week history of opioid-associated constipation symptoms. 3) Patients must be between 18 and 85 years of age. 4) Patients with stable cancer status and an expected survival of >3 months 5) The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3. 6) Prior to cancer pain screening, patients must be on a relatively stable opioid regimen consisting of 30 mg to 1000 mg oral morphine equivalents daily for at least 2 weeks. In addition, opioids are expected to be maintained for at least 10 weeks. 7) The patient's spontaneous bowel movement (SBM) frequency is 2 times per week without laxatives. 8) Patients must have the ability to take oral medications, food, and drink. 9) A voluntary signed patient informed consent form
Exclusion criteria
Exclusion criteria: 1) Patients diagnosed with clinically significant defecation abnormalities due to abnormalities of the gastrointestinal tract and other tissues associated with the gastrointestinal tract (excluding OIC): inflammatory bowel disease, rectal prolapse, gastrointestinal obstruction, peritoneal metastases, or peritoneal tumors 2) Patients with a history of gastrointestinal surgery, abdominal surgery, or abdominal adhesions within one month prior to screening; patients with a history of intestinal obstruction within three months prior to screening 3) Diagnosis of active diverticular disease, severe hemorrhoids, anal fissures; or artificial rectum or anus Patients with an intra-abdominal catheter or feeding tube 5) Diagnosis of pelvic disease that significantly affects intestinal transport of feces (e.g., uterine prolapse = 2 degrees, uterine fibroids [located in the posterior part of the uterus, = 5 cm in diameter] affecting intestinal motility) 6) Patients who are receiving new chemotherapy for cancer within 14 days prior to screening, who have never had chemotherapy in the past, or who are scheduled to receive chemotherapy during the study period 7) Patients who have received radiotherapy within 28 days prior to screening or are scheduled to receive radiotherapy during the study period 8) Patients who have undergone a procedure or intervention that has a significant impact on gastrointestinal function within 28 days prior to screening or who are scheduled to undergo a procedure or intervention that has a significant impact on gastrointestinal function during the study period or who are scheduled to undergo a procedure or intervention that may prevent the patient from completing the trial 9) Patients with uncontrolled hyperthyroidism, severe hypertension, heart disease, systemic infection, or blood clotting disorders (hypercoagulable state or bleeding tendencies) at the time of study inclusion 10) Patients who consumed >4 additional opioid doses per day for more than 3 days during the baseline period due to fulminant pain or who changed their maintenance opioid dosing regimen during this period 11) Patients with severe cancer pain (e.g., typical average daily pain intensity rating of 7 to 10 (NRS; 0 [no pain] to 10 [worst possible pain]) following treatment with conventional doses and frequency of opioids 12) Patients with a history of opioid discontinuation due to a serious adverse event or patients with anticipated opioid discontinuation due to a potential risk of adverse events 13) Patients who have received an opioid receptor antagonist within one month of screening or who are scheduled to receive such treatment during the study period 14) Patients with a history of neuroleptic release 15) Patients with severe cognitive impairment, aphasia or psychiatric disorder; abdominal aortic aneurysm; hepatomegaly (liver span >14 cm at midclavicular line on ultrasound); or splenomegaly (spleen length [from head to tail] >13 cm on ultrasound) 16) Patients who had received acupuncture treatment within the previous three months were screened. 17) Other patients who were deemed ineligible for the study by the investigator based on combined treatment and medical outcomes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Respondent ratio; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in average weekly spontaneous bowel movements (SBMs) during weeks 1-8.;Proportion of patients with an average of =3 spontaneous bowel movements (SBM) per week in weeks 1-8;Proportion of patients with an increase of =1 spontaneous bowel movement per week, on average, from baseline in weeks 1-8;Change from Baseline in Mean Weekly Completely Spontaneous Bowel Movements (CSBMs) at Weeks 1-8;Proportion of patients with an average of =3 completely spontaneous bowel movements (CSBMs) per week in weeks 1-8;Proportion of patients with =1 increase from baseline in the mean number of completely spontaneous bowel movements (CSBMs) per week at weeks 1-8;Change from Baseline in Mean Bristol Stool Scale Score for Stool Consistency in Spontaneous Bowel Movements (SBMs) at Weeks 1-8 ;Change from Baseline in Mean Score for Tension in Spontaneous Bowel Movements (SBMs) at Weeks 1-8;Change from baseline in total and subscale scores on the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire at weeks 2 and 8 ;Change from baseline in total and subscale scores on the Patient Assessment of Constipation-Quality of Life (PAC-QOL) questionnaire at weeks 2 and 8;Patient's overall assessment of efficacy;Proportion of patients using rescue medication and average frequency of rescue medication use per week in weeks 1-8; | — |
Countries
China
Contacts
Public ContactFanming Kong
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed