Constipation, Opioid-InducedNCT06537440
Electroacupuncture for Opioid-Induced Constipation in Cancer Patients: A Randomized Clinical Trial
A study testing Electroacupuncture in people with Constipation, Opioid-Induced and Cancer, run by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Constipation, Opioid-Induced, Cancer
- What is being tested?
- Electroacupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2024to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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;
- Exclusion of Gastrointestinal Motility Agents: Participants must not have used any gastrointestinal motility-promoting drugs within 1 week prior to randomization.
Who cannot join
- 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;
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- 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;
- Recent Acupuncture Treatment: Participants who have received acupuncture treatment within 3 months prior to screening;
- Participation in Other Clinical Trials: Participants who have participated in or are currently participating in another clinical trial within the past 3 months;
- Other Medical or Treatment Conditions: Any other participants deemed by the investigator to be unsuitable for the study due to concomitant treatments or medical findings.
Trial locations and contacts
1 site in 1 country.
China1 site
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, 300193
About this study
Official title: Electroacupuncture for the Management of Opioid-Induced Constipation in Patients With Cancer: a Study Protocol for a Single-Center, Single-Blind, Randomized Controlled Trial
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
- Being tested
- Electroacupuncture
- Keywords
- Opioid-related constipation, cancer, electroacupuncture, sham electroacupuncture control
- Medical subject headings
- Opioid-Induced Constipation, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureOther
Electroacupuncture TE6 Zhigou (double), ST36 Zusanli (double), ST25 Tianshu (double), CV12 Zhongwan
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the end of the 1-week treatment period
Secondary outcomes (9)
The weekly mean number of SBMs
Measured: (1)Assessments will be conducted at baseline, Week 1 (end of treatment), Week 2, and Week 3 (follow-up).
Weekly mean CSBMs
CSBMs are defined as SBMs accompanied by a self-reported sense of complete evacuation
Measured: 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
Stool consistency will be assessed using the Bristol Stool Form Scale (BSFS), a validated 7-point scale ranging from Type 1 (hard, lumpy) to Type 7 (watery). Types 3-5 are considered normal
Measured: Assessments will be conducted at baseline, Week 1 (end of treatment), Week 2, and Week 3 (follow-up).
Weekly mean straining of constipation scores
Straining will be self-rated using a 5-point scale: 0 = not at all difficult, 1 = a little bit, 2 = moderately, 3 = quite a bit, and 4 = extremely difficult.
Measured: 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.
Measured: 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).
The Patient Assessment of Constipation-Symptom (PAC-SYM) scores
Changes in symptom severity will be assessed using the Patient Assessment of Constipation-Symptom (PAC-SYM) questionnaire, a 12-item instrument evaluating symptoms over the past 2 weeks. It includes abdominal (4 items), rectal (3 items), and stool (5 items) subscales. Each item is scored from 0 (no symptom) to 4 (very severe), with lower scores indicating milder symptoms. Subscale and total scores are calculated as the mean of completed items.
Measured: The validated Chinese version of PAC-SYM will be used, assessed at baseline, Week 1, and Week 3.
The Patient Assessment of Constipation-Quality of Life (PAC-QOL) scores
The Patient Assessment of Constipation-Quality of Life (PAC-QOL) questionnaire assesses the impact of constipation on daily functioning and well-being over the past 2 weeks. It contains 28 items across four subscales: physical discomfort (items 1-4), psychosocial discomfort (items 5-12), worries/concerns (items 13-23), and satisfaction (items 24-28). Each item is scored from 0 (not at all) to 4 (extremely), with lower scores indicating better quality of life.
Measured: The validated Chinese version will be administered at baseline, Week 1, and Week 3.
Patients' global assessment of treatment efficacy.
Participants will rate their perceived treatment efficacy using a 7-point global assessment scale: 1 = markedly worse, 2 = moderately worse, 3 = slightly worse, 4 = no change, 5 = slightly improved, 6 = moderately improved, 7 = markedly improved. This scale has demonstrated reliability and ease of use.
Measured: Assessment will be conducted on Day 7.
The changes in gut microbiota and microbial metabolites.
16S ribosomal RNA (16S rRNA) gene sequencing was performed to evaluate the composition, diversity, and relative abundance of gut microbial communities.In parallel, untargeted metabolomic profiling using liquid chromatography-mass spectrometry (LC-MS) will be conducted to identify and quantify microbial metabolites.
Measured: Fecal samples were collected at baseline and after the 1-week treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start10 Jan 2024
- Primary completion22 Oct 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipation, Opioid-InducedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kong Fanming, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537440
- Sponsor's protocol ID
- TYLL2023[Z]字012
- Status last verified
- Nov 2025
- First submitted
- 1 Aug 2024
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroacupuncture for the Management of Opioid-Induced Constipation in Patients With Cancer: a Study Protocol for a Single-Center, Single-Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06537440
- Acronym / sponsor ID
- TYLL2023[Z]字012
- Conditions
- Constipation, Opioid-Induced, Cancer
- Keywords
- Opioid-related constipation, cancer, electroacupuncture, sham electroacupuncture control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- First Teaching Hospital of Tianjin University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 22 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture group | Experimental | Other: ElectroacupunctureIn 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. |
| Sham Acupuncture group | Sham comparator | Other: ElectroacupunctureParticipants 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (18 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroacupunctureElectroacupuncture TE6 Zhigou (double), ST36 Zusanli (double), ST25 Tianshu (double), CV12 Zhongwan | Other | Electroacupuncture group, Sham Acupuncture group |
Primary outcome
The proportion of responders.
Time frame: At the end of the 1-week treatment period
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.
9 secondary outcomes
The weekly mean number of SBMs
Time frame: (1)Assessments will be conducted at baseline, Week 1 (end of treatment), Week 2, and Week 3 (follow-up).
Weekly mean CSBMs
Time frame: 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
Time frame: Assessments will be conducted at baseline, Week 1 (end of treatment), Week 2, and Week 3 (follow-up).
Weekly mean straining of constipation scores
Time frame: 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.
Time frame: 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).
The Patient Assessment of Constipation-Symptom (PAC-SYM) scores
Time frame: The validated Chinese version of PAC-SYM will be used, assessed at baseline, Week 1, and Week 3.
The Patient Assessment of Constipation-Quality of Life (PAC-QOL) scores
Time frame: The validated Chinese version will be administered at baseline, Week 1, and Week 3.
Patients' global assessment of treatment efficacy.
Time frame: Assessment will be conducted on Day 7.
The changes in gut microbiota and microbial metabolites.
Time frame: Fecal samples were collected at baseline and after the 1-week treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture in people with Constipation, Opioid-Induced and Cancer, run by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of responders. (time frame: At the end of the 1-week treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.