Electroacupuncture for Opioid-Induced Constipation in Cancer Patients: A Randomized Clinical Trial

NCT06537440 | Completed DMC

• 1 other identifier: TYLL2023[Z]字012
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this trial is to evaluate the efficacy and safety of electroacupuncture in the management of opioid-induced constipation in patients with cancer.

Conditions

Constipation, Opioid-Induced; Cancer

Keywords

Opioid-related constipation; cancer; electroacupuncture; sham electroacupuncture control

Outcome Measures

Primary Outcomes (1)

• The proportion of responders.

  Patients will have at least three spontaneous bowel movements (SBMs) per week during the treatment period and an increase of at least one SBM from baseline during the treatment period. A bowel movement can only be described as SBM if it has occurred without any intervention to assist in defecation in the past 24 hours.

  At the end of the 1-week treatment period

Secondary Outcomes (9)

• The weekly mean number of SBMs

  (1)Assessments will be conducted at baseline, Week 1 (end of treatment), Week 2, and Week 3 (follow-up).

• Weekly mean CSBMs

  Assessments will be conducted at baseline, Week 1 (end of treatment), Week 2, and Week 3 (follow-up).

• Weekly mean Bristol Stool Form Scale (BSFS) score

  Assessments will be conducted at baseline, Week 1 (end of treatment), Week 2, and Week 3 (follow-up).

• Weekly mean straining of constipation scores

  Participants will complete daily scores; weekly mean scores will be will be calculated at baseline, Week 1 (end of treatment), Week 2, and Week 3 (follow-up).

• Use of Rescue Medications or Other Bowel Support Measures.

  The proportion of participants requiring rescue interventions (e.g., laxatives, enemas, suppositories) and the mean frequency of use per week will be recorded from the start of treatment (Day 0) through the end of follow-up (Day 21).

Study Arms (2)

Electroacupuncture group

EXPERIMENTAL

In the EA group, acupoints TE6, ST36, ST25, and CV12 will be used. With the participant lying supine, the skin will be disinfected before needle insertion. For ST25 and CV12, 0.25×50 mm needles will be inserted vertically into the abdominal muscle layer until Deqi is achieved. For TE6 and ST36, needles measuring 0.25 × 40 mm and 0.25 × 50 mm, respectively, will be inserted vertically to depths of approximately 15 mm and 35 mm. Manual stimulation will be applied using three uniform lifting, thrusting, and twirling manipulations to elicit Deqi. Electrodes from an SDZ-V EA device will then be attached to TE6 and ST36. A continuous 20 Hz electrical stimulation at 0.5-4 mA (based on tolerance) will be applied for 30 minutes.

Other: Electroacupuncture

Sham Acupuncture group

SHAM COMPARATOR

Participants in the SA group will receive shallow needle insertion (2-3 mm) at non-acupoint sites near TE6, ST36, ST25, and CV12. After skin disinfection, 0.25×40 mm sterile needles will be inserted without manual stimulation or eliciting Deqi. The sham electrode wires attached to the pseudo-TE6 and ST36 points will appear identical to those used in the EA group; however, the internal metal conductors will be cut to prevent current transmission. As a result, although the electrical stimulation device will display an active status (with indicator lights on and sound output), no actual electrical current will be delivered. The stimulation parameters and treatment duration will mirror those used in the EA group.

Other: Electroacupuncture

Interventions

Electroacupuncture OTHER

Electroacupuncture TE6 Zhigou (double), ST36 Zusanli (double), ST25 Tianshu (double), CV12 Zhongwan

Electroacupuncture group; Sham Acupuncture group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of OIC based on the Rome IV Criteria: Participants must meet the following criteria for OIC: Constipation or worsening of constipation symptoms during opioid use or dose changes, with at least two of the following symptoms: 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); 6. less than 3 bowel movements per week; (2) the rare occurrence of loose stools when laxatives were not used.
• Rare occurrence of loose stools without the use of laxatives;
• History of OIC symptoms for at least 1 week prior to enrollment;
• Age: Participants must be aged between 18 and 85 years;
• Cancer Status: Participants must have stable cancer with a life expectancy of greater than 6 months;
• ECOG Performance Status: Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3;
• Stable Opioid Maintenance: Participants must have been receiving a relatively stable opioid regimen for at least 2 weeks prior to screening, with a daily morphine equivalent dose (MED) ranging from 30 mg to 1000 mg. Additionally, opioid treatment is expected to continue for at least 10 weeks;
• Bowel Movement Frequency: In the absence of laxative use, participants must have fewer than two spontaneous bowel movements (SBMs) per week;
• Ability to Take Oral Medications: Participants must be capable of swallowing oral medications, food, and beverages;
• Informed Consent: Participants must voluntarily consent to participate in the trial and provide signed informed consent;

You may not qualify if:

• Significant Bowel Dysfunction due to Gastrointestinal or Other Structural Abnormalities: Participants diagnosed with clinically significant bowel dysfunction resulting from gastrointestinal or related structural abnormalities (excluding OIC), such as inflammatory bowel disease, rectal prolapse, gastrointestinal obstruction, peritoneal metastases, or peritoneal tumors;
• Recent History of Abdominal Surgery: Participants with a history of gastrointestinal or abdominal surgery, or abdominal adhesions within 1 month prior to screening; or a history of bowel obstruction within 3 months prior to screening;
• Active Gastrointestinal Conditions: Diagnosis of active diverticular disease, severe hemorrhoids, anal fissures, or artificial rectum or anus;
• Presence of Abdominal Catheters or Feeding Tubes: Participants with abdominal catheters or feeding tubes in place;
• Pelvic Diseases Affecting Bowel Transit: Participants diagnosed with pelvic diseases known to significantly affect bowel transit (e.g., ≥2nd degree uterine prolapse, uterine fibroids ≥5 cm located in the posterior uterus);
• Recent or Planned Chemotherapy: Participants who received a new chemotherapy regimen within 14 days of screening, or who plan to receive such treatment during the study period;
• Recent or Planned Radiotherapy: Participants who received radiotherapy within 28 days prior to screening, or who plan to undergo radiotherapy during the study period;
• Recent Gastrointestinal Surgery or Interventions: Participants who have undergone or are scheduled to undergo surgeries or interventions within 28 days of screening that could significantly affect gastrointestinal function or are expected to prevent completion of the trial;
• Uncontrolled Medical Conditions: Participants with uncontrolled hyperthyroidism, severe hypertension, cardiovascular disease, systemic infections, or coagulation disorders (e.g., hypercoagulability or bleeding tendencies);
• Excessive Use of Opioids Due to Acute Pain: Participants who have required more than four additional doses of opioid analgesics per day for more than 3 consecutive days during the baseline period due to acute pain, or those who have modified their opioid maintenance regimen during this period;
• Severe Cancer Pain Unresponsive to Opioids: Participants who experience severe cancer-related pain despite standard opioid therapy (e.g., average daily pain intensity of 7-10 on the Numerical Rating Scale \[NRS\], where 0 is "no pain" and 10 is "the worst pain possible");
• History of Opioid Discontinuation Due to Severe Adverse Events: Participants with a history of opioid discontinuation due to severe adverse events, or those expected to discontinue opioid use due to potential risks of adverse events;
• Recent Use of Opioid Antagonists: Participants who have received opioid receptor antagonists within 1 month prior to screening;
• Inability to Provide Informed Consent: Participants who are unconscious, psychotic, or unable to express subjective symptoms. (As acupuncture is an invasive procedure requiring 30 minutes per session, such participants will be excluded for safety reasons.);
• Bleeding Disorders: Participants with bleeding disorders, as acupuncture involves skin penetration, and individuals with bleeding tendencies are at increased risk of complications;

Sponsors & Collaborators

• First Teaching Hospital of Tianjin University of Traditional Chinese Medicine: lead

Study Sites (1)

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, 300193, China

Location

MeSH Terms

Conditions

Opioid-Induced Constipation; Neoplasms

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Constipation; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Due to the specific nature of acupuncture clinical research, it is difficult to accomplish double blinding of subjects and operators, so this trial was blinded to subjects, outcome assessors, and statisticians only. To assess the success of blinding, all patients who received acupuncture were asked to guess their group allocation five minutes after the completion of treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chairman of section

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 5, 2024
• Study Start: January 10, 2024
• Primary Completion: October 22, 2025
• Study Completion: October 30, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

CN (1)