Effect of Acupuncture on Opioid-associated Constipation in Cancer Patients

Inclusion Criteria:

1. Cancer patients must meet the diagnostic criteria of Rome IV Opioid-RelatedConstipation: (1) Constipation or worsening of constipation symptoms with opioid useor dose change, etc., must include 2 or more of the following: (1) at least 25% ofbowel movements are labored; (2) at least 25% of bowel movements are dry ball orhard stools; (3) at least 25% of bowel movements are incomplete; (4) at least 25% ofbowel movements have anal rectal obstruction and/or blockage in at least 25% of thebowel movements; (5) at least 25% of the bowel movements required manual assistance (e.g., finger-assisted defecation, pelvic floor support); less than 3 bowelmovements per week; (2) the rare occurrence of loose stools when laxatives were notused.

2. Patients recruited for this trial must have at least a 1-week history ofopioid-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) performancestatus of 0-3.

6. Prior to cancer pain screening, patients must be on a relatively stable opioidregimen 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 withoutlaxatives.

8. Patients must have the ability to take oral medications, food, and drink.

9. A voluntary signed patient informed consent form

Exclusion Criteria:

1. Patients diagnosed with clinically significant defecation abnormalities due toabnormalities of the gastrointestinal tract and other tissues associated with thegastrointestinal 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 abdominaladhesions within one month prior to screening; patients with a history of intestinalobstruction within three months prior to screening

3. Diagnosis of active diverticular disease, severe hemorrhoids, anal fissures; orartificial rectum or anus

4. 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 partof the uterus, ≥ 5 cm in diameter] affecting intestinal motility)

6. Patients who are receiving new chemotherapy for cancer within 14 days prior toscreening, who have never had chemotherapy in the past, or who are scheduled toreceive chemotherapy during the study period

7. Patients who have received radiotherapy within 28 days prior to screening or arescheduled to receive radiotherapy during the study period

8. Patients who have undergone a procedure or intervention that has a significantimpact on gastrointestinal function within 28 days prior to screening or who arescheduled to undergo a procedure or intervention that has a significant impact ongastrointestinal function during the study period or who are scheduled to undergo aprocedure 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 bleedingtendencies) at the time of study inclusion

10. Patients who consumed >4 additional opioid doses per day for more than 3 days duringthe baseline period due to fulminant pain or who changed their maintenance opioiddosing regimen during this period

11. Patients with severe cancer pain (e.g., typical average daily pain intensity ratingof 7 to 10 (NRS; 0 [no pain] to 10 [worst possible pain]) following treatment withconventional doses and frequency of opioids

12. Patients with a history of opioid discontinuation due to a serious adverse event orpatients with anticipated opioid discontinuation due to a potential risk of adverseevents

13. Patients who have received an opioid receptor antagonist within one month ofscreening 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 onultrasound); or splenomegaly (spleen length [from head to tail] >13 cm onultrasound)

16. Patients who had received acupuncture treatment within the previous three monthswere screened.

17. Other patients who were deemed ineligible for the study by the investigator based oncombined treatment and medical outcomes