Opioid-induced Constipation in Patients With CancerNCT03797586
Effect of Electroacupuncture on Opioid-induced Constipation in Patients With Cancer
A study testing Electroacupuncture group in people with Opioid-induced Constipation in Patients With Cancer, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
Approximately 70-80% of patients with advanced disease will be affected by moderate to severe pain. Opioid analgesics represented by morphine and oxycodone are the cornerstone of cancer-pain management, and recommended for use in the management of moderate to severe cancer pain according to WHO Cancer Pain Relief… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Opioid-induced Constipation in Patients With Cancer
- What is being tested?
- Electroacupuncture group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2019to 11 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Cancer patients who conformed to all the following conditions will be further screened for eligibility:
- Cancer patients must meet the Rome IV[1] diagnostic criteria for OIC: New or worsening symptoms of constipation following initiation, alteration, or increase in opioid treatment. For patients with a history of chronic functional constipation, he/she must have worsening symptoms of constipation when the opioid therapy is initiated, changed, or the dose is increased;
- Patients recruited in this trial must have a history of OIC symptoms for at least 1 week;
- Patients must be ≥18 years of age and ≤85 years of age;
- Patient's cancer condition must be stable with a life expectancy that is more than six months;
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3;
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- Patients must have been receiving a relatively stable maintained opioid regimen, consisting of a total daily dose of 30 mg to 1000 mg oral morphine equivalents for at least 2 weeks prior to screening for cancer pain. Furthermore, it must be anticipated that the opioid will be maintained for at least 10 weeks;
- The SBM frequency of the patients must be ≤ 2 times a week when laxatives are not being taken;
- Patients must be capable of oral intake of drugs, food and beverages;
- Provision of written informed consent before participation.
Who cannot join
- Participants who fulfill any of the following criteria will be excluded:
- Patients diagnosed with clinically significant abnormal defecation due to structural abnormalities of the gastrointestinal tract and other tissues related to gastrointestinal tract (not including OIC): inflammatory bowel disease, rectal prolapse, gastrointestinal obstruction, peritoneal metastasis, or peritoneal tumor at the time of enrollment;
- Patients with a history of gastrointestinal tract operation, abdominal operation, or abdominal adhesion within one month prior to screening; history of intestinal obstruction within three months prior to screening;
- Diagnosis of active diverticular disease; or severe hemorrhoid; or anal fissure; or artificial rectum or anus;
- Patients with an intraperitoneal catheter or a feeding tube;
- Diagnosis of pelvic disorder which are considered to have obvious effects on the intestinal transport of feces (such as uterine prolapse ≥degree 2, uterine fibroids [located in the posterior of the uterus with a diameter ≥ 5 cm] affecting bowel movement);
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- Patients that are being treated with a new cancer chemotherapy, which had never been administered in the past, within 14 days of the screening or are scheduled to receive such therapy during the study;
- Patients that received radiotherapy within 28 days of the screening or are scheduled to receive such therapy during the study;
- Patients that underwent a surgery or intervention that is considered to have an obvious effect on the gastrointestinal functions within 28 days of the screening or are scheduled to receive surgery or intervention which is considered to have obvious effects on the gastrointestinal functions during the study, or scheduled to receive surgery or intervention which will be anticipated to prevent the patients from completing the trial;
- Patients with uncontrolled hyperthyroidism, severe hypertension, heart disease, systematic infection or blood coagulation disorders (hypercoagulation status or hemorrhagic tendency) at the time of study inclusion;
- Patients that consumed >4 additional opioid doses per day, for breakthrough pain, for more than 3 days during the baseline period, or if their maintenance opioid dosing regimen was modified during this period;
- Patients with severe cancerous pain (e.g., typical average daily pain intensity rating of 7 to 10 on a numerical rating scales (NRS; 0 [no pain] to 10 [the worst pain possible]) after the use of routine dose and frequency of opioids) refractory to opioid therapy;
- Patients with a history of opioid discontinuation due to severe adverse events or patients that are expected to discontinue opioid use due to the potential risk of adverse events;
- Patients that received an opioid receptor antagonist within one month of the screening, or those who are scheduled to receive such therapy during the study;
- Patients with a history of nerve neurolysis;
- Patients with severe cognitive impairment, aphasia, or psychiatric disorders; abdominal aortic aneurysm; hepatomegaly(liver span > 14cm at the mid-clavicular line by ultrasound examination); or splenomegaly (spleen length [cranial to caudal] > 13cm by ultrasound examination);
- Patients that have received acupuncture within three months of the screening;
- Other patients who are considered ineligible for the study by the investigator on the basis of concomitant therapy and medical findings.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Electroacupuncture on Opioid-induced Constipation in Patients With Cancer: Study Protocol for a Multicenter Randomized Controlled Trial
Approximately 70-80% of patients with advanced disease will be affected by moderate to severe pain. Opioid analgesics represented by morphine and oxycodone are the cornerstone of cancer-pain management, and recommended for use in the management of moderate to severe cancer pain according to WHO Cancer Pain Relief Guidelines. One view is that a trial of systemic opioid therapy should be administered to all cancer patients with pain of moderate or greater severity regardless of the pain mechanism. Although opioids analgesics do work well as relieving pain and improving quality of life via their action at opioid receptors in the central nervous system (CNS) and the peripheral nervous system, they also have powerful adverse effects. The overall occurrence of opioid-related adverse drug events has ranged from1.8% to 13.6%. Opioid-induced constipation (OIC), one of the most prevalent adverse events (AEs) in patients receiving opioid analgesics, defined as a change in baseline bowel habits or defecatory patterns following initiation, alteration, or increase in opioid therapy. The prevalence of OIC has been estimated to affect 41% of patients with chronic noncancer pain taking opioids and 94% of cancer patients taking opioids for pain. Unlike many other opioid-related AEs, OIC is persistent and rarely tolerated. OIC impacts pain control, patients' quality of life and may cause patients to reduce the dose or discontinue opioid use.
Acupuncture, a traditional Chinese medicine, has been used to treat gastrointestinal disease including constipation for thousands of years. Two systematic reviews concluded that acupuncture can improve spontaneous bowel movements for functional constipation, and our recent study indicated that electroacupuncture(EA) could increase complete spontaneous bowel movements and is safe for chronic severe functional constipation. Acupuncture could improve gastrointestinal function via facilitating gastrointestinal motility. Currently, there is little detailed information available regarding the acupuncture use for OIC. The objective of this study is to assess the efficacy and safety of EA for OIC in patients with cancer.
- Being tested
- Electroacupuncture group, Sham electroacupuncture group
- Keywords
- electroacupuncture；opioid-induced constipation ,cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroacupuncture groupOther
Bilateral Tianshu (ST25), Fujie (SP14), Shangjuxu (ST37) will be used in the EA group. With the local skin of the patients was routinely sterilized in a prone position in relaxation, acupuncturists will insert needles into the acupuncture points. For ST25 and SP14, 0.30×50mm or 0.30×75mm needles will be vertically inserted to the muscle layer of the abdominal wall, where participants will feel sharp pain and acupuncturists will feel resistance from the needle tip. For ST37, 0.30×40 mm needles will be vertically inserted approximately 15 mm deep, followed by three-time manipulation of even lifting and twisting method to elicit the sensation of deqi. Then paired alligator clips of the EA apparatus will be attached to the needle holders of the bilateral ST25, SP14, and ST37. EA stimulation will be retained for 30 minutes with a continuous wave of 10 Hz and current intensity of 0.5 to 4 mA.
Sham electroacupuncture groupOther
Bilateral sham ST25, SP14, and ST37 will be used in the SA group. After sterilizing the skin, 0.30×40mm needles will be straightly inserted at the sham points about 2-3mm until they can be fixed on the skin when attached by the alligator clips. No manipulation will be used, and no deqi sensation are elicited for all sham points. The bilateral sham ST25, SP14, and ST37 points will be attached by the same EA apparatus with a continuous wave of 10 Hz and current intensity of 0.1 to 0.2 mA for 30 minutes with only the initial 30 seconds on.
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture group | Experimental | Bilateral ST25,SP14, ST37 will be used in the EA group. For ST25 and SP14, 0.30×50mm or 0.30×75mm needles will be vertically inserted to the muscle layer of the abdominal , where patients will feel sharp pain and acupuncturists will feel resistance from the needle tip. For ST37, 0.30×40 mm needles will be vertically inserted approximately 15 mm deep, followed by three-time manipulation of even lifting and twisting method to elicit the sensation of deqi. Then paired alligator clips of the EA apparatus will be attached to the needle holders of the bilateral ST25, SP14, and ST37. EA stimulation will be retained for 30 minutes with a continuous wave of 10 Hz and current intensity of 0.5 to 4 mA. Receives: Other: Electroacupuncture group |
| Sham electroacupuncture group | Sham comparator | Bilateral sham ST25, SP14, and ST37 will be used in the SA group. After sterilizing the skin, 0.30×40mm needles will be straightly inserted at the sham points about 2-3mm until they can be fixed on the skin when attached by the alligator clips. No manipulation will be used, and no deqi sensation are elicited for all sham points. The bilateral sham ST25, SP14, and ST37 points will be attached by the same EA apparatus with a continuous wave of 10 Hz and current intensity of 0.1 to 0.2 mA for 30 minutes with only the initial 30 seconds on. Receives: Other: Sham electroacupuncture group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Response
A responder（Participant With Response） is defined as a patient that has at least three spontaneous bowel movements (SBMs) per week and an increase of at least one SBM a week from the baseline for at least 6 of the 8 weeks of the treatment period.
Measured: weeks 1-8
Secondary outcomes (17)
A Change in the Mean Weekly Spontaneous Bowel Movements (SBMs) From the Baseline During Weeks 1-8 and Weeks 13-16.
An SBM was defined as a bowel movement that occurred without any medication or intervention to assist defection within the previous 24 hours. A bowel movement occurring within 24 hours of an optional assisted method for defecation was not considered to be an SBM. The mean weekly spontaneous bowel movements (SBMs) during weeks 1-8 and weeks 13-16 is calculated by dividing the total frequency of SBMs by the number of weeks recorded.
Measured: weeks 1-8, and weeks 13-16
Number of Participants With ≥3 Mean Weekly Spontaneous Bowel Movements (SBMs) During Weeks 1-8
An SBM was defined as a bowel movement that occurred without any medication or intervention to assist defection within the previous 24 hours. A bowel movement occurring within 24 hours of an optional assisted method for defecation was not considered to be an SBM. The mean weekly spontaneous bowel movements (SBMs) during weeks 1-8 is calculated by dividing the total frequency of SBMs by the number of weeks recorded.
Measured: weeks 1-8
Number of Participants With ≥3 Mean Weekly Spontaneous Bowel Movements (SBMs) During Weeks 13-16
An SBM was defined as a bowel movement that occurred without any medication or intervention to assist defection within the previous 24 hours. A bowel movement occurring within 24 hours of an optional assisted method for defecation was not considered to be an SBM.The mean weekly spontaneous bowel movements (SBMs) during weeks 13-16 is calculated by dividing the total frequency of SBMs by the number of weeks recorded.
Measured: weeks 13-16
Number of Participants With an Increase of ≥1 Mean Weekly Spontaneous Bowel Movements (SBMs) From the Baseline During Weeks 1-8
An SBM was defined as a bowel movement that occurred without any medication or intervention to assist defection within the previous 24 hours. A bowel movement occurring within 24 hours of an optional assisted method for defecation was not considered to be an SBM. The mean weekly spontaneous bowel movements (SBMs) during weeks 1-8 is calculated by dividing the total frequency of SBMs by the number of weeks recorded.
Measured: weeks 1-8
Number of Participants With an Increase of ≥1 Mean Weekly Spontaneous Bowel Movements (SBMs) From the Baseline During Weeks 13-16
An SBM was defined as a bowel movement that occurred without any medication or intervention to assist defection within the previous 24 hours. A bowel movement occurring within 24 hours of an optional assisted method for defecation was not considered to be an SBM. The mean weekly spontaneous bowel movements (SBMs) during weeks 13-16 is calculated by dividing the total frequency of SBMs by the number of weeks recorded.
Measured: weeks 13-16
A Change in the Mean Weekly Complete Spontaneous Bowel Movements (CSBMs) From the Baseline During Weeks 1-8 and Weeks 13-16.
An SBM was defined as a bowel movement that occurred without any medication or intervention to assist defection within the previous 24 hours. A bowel movement occurring within 24 hours of an optional assisted method for defecation was not considered to be an SBM. A CSBM was defined as an SBM with the feeling of complete evacuation. The mean weekly complete spontaneous bowel movements (CSBMs) during weeks 1-8 and weeks 13-16 is calculated by dividing the total frequency of CSBMs by the number of weeks recorded.
Measured: weeks 1-8, and weeks 13-16
Number of Participants With ≥3 Mean Weekly Spontaneous Bowel Movements (CSBMs) During Weeks 1-8
An SBM was defined as a bowel movement that occurred without any medication or intervention to assist defection within the previous 24 hours. A bowel movement occurring within 24 hours of an optional assisted method for defecation was not considered to be an SBM. A CSBM was defined as an SBM with the feeling of complete evacuation.
Measured: weeks 1-8
Number of Participants With ≥3 Mean Weekly Spontaneous Bowel Movements (CSBMs) During Weeks 13-16
An SBM was defined as a bowel movement that occurred without any medication or intervention to assist defection within the previous 24 hours. A bowel movement occurring within 24 hours of an optional assisted method for defecation was not considered to be an SBM. A CSBM was defined as an SBM with the feeling of complete evacuation.
Measured: weeks 13-16
Number of Participants With an Increase of ≥1 Mean Weekly Spontaneous Bowel Movements (CSBMs) From the Baseline During Weeks 1-8
An SBM was defined as a bowel movement that occurred without any medication or intervention to assist defection within the previous 24 hours. A bowel movement occurring within 24 hours of an optional assisted method for defecation was not considered to be an SBM. A CSBM was defined as an SBM with the feeling of complete evacuation.
Measured: weeks 1-8
Number of Participants With an Increase of ≥1 Mean Weekly Spontaneous Bowel Movements (CSBMs) From the Baseline During Weeks 13-16
An SBM was defined as a bowel movement that occurred without any medication or intervention to assist defection within the previous 24 hours. A bowel movement occurring within 24 hours of an optional assisted method for defecation was not considered to be an SBM. A CSBM was defined as an SBM with the feeling of complete evacuation.
Measured: weeks 13-16
A Change in the Mean Bristol Stool Form Scale Score for Stool Consistency of Spontaneous Bowel Movements (SBMs) From the Baseline During Weeks 1-8 and Weeks 13-16
For stool consistency, each patient was asked to record their stool consistency according to the Bristol Stool Form Scale, on the following seven points scale (scored from 1 to 7 for stool types 1 to 7, respectively) .Higher scores indicate indicating a softer stool.The mean Bristol Stool Form Scale score for stool consistency of spontaneous bowel movements (SBMs) during weeks 1-8 and weeks 13-16 is calculated by dividing the total Bristol Stool Form Scale score of SBMs by the total number of SBMs recorded.
Measured: weeks 1-8, and weeks 13-16
A Change in the Mean Score for the Straining of Spontaneous Bowel Movements (SBMs) From the Baseline During Weeks 1-8 and Weeks 13-16
For assessment of straining of spontaneous bowel movement (SBM), each patient was asked to rate his/her score for straining using the following five-point scale: not at all difficulty (0), a little bit difficulty (1), moderately difficulty (2), quite a bit difficulty (3), extremely difficulty (4). Higher scores indicate a worse outcome.The mean score for the straining of SBMs during weeks 1-8 and weeks 13-16 is calculated by dividing the total score for the straining of SBMs by the total number of SBMs recorded.
Measured: weeks 1-8, and weeks 13-16
A Change in the Total Score of the Patient Assessment of Constipation-Symptom (PAC-SYM) Questionnaire From Baseline at Weeks 8 and 16
The Patient Assessment of Constipation-Symptom (PAC-SYM) is a 12-item evaluative questionnaire for the chronic constipation, which consists of 4-item abdominal, 3-item rectal, and 5-item stool subscales. Each item score ranges from 0 to 4 in the 2 weeks (14 days) prior to assessment，where 0 = symptom absent, 1 = mild,2 = moderate,3 = severe and 4 = very severe. Each subscale score will be calculated as the mean of the completed items for that subscale，which will range from 0 to 4. The total score will be calculated as the mean of all subscales. The total score of PAC-SYM range from 0 to 4.Lower scores indicate a better outcome. The specific evaluation of total scores of the PAC-SYM occurs at both week 8 and week 16.
Measured: week 8 and week 16
A Change in the Total Scores of the Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaires From the Baseline at Weeks 8 and 16
The Patient Assessment of Constipation-Quality of Life (PAC-QOL) is a 28-item self-reported instrument for assessing the burden of constipation on patients' everyday functioning and well-being in the 2 weeks (14 days) prior to assessment. It is divided into four subscales: physical discomfort (items 1-4), psychosocial discomfort (items 5-12), worries/concerns (items 13-23), and satisfaction (items 24 to 28). Each of the item scores ranges from 0 (not at all) to 4 (extremely). Each of the item scores ranges from 0 (not at all) to 4 (extremely), with lower scores indicating a better quality of life. The each subscale score ranges from 0 to 4. The total score will be calculated as the mean of all subscales, ranging from 0 to 4. Lower scores indicate a better outcome. The specific evaluation of the PAC-QOL questionnaires' total scores occurs at both week 8 and week 16.
Measured: week 8 and week 16
Patients'Global Assessment of Treatment Efficacy
Each patient was asked to rate his/her efficacy of treatment using the following 7-point self-reporting scale: markedly worse (1), moderately worse (2),slightly worse (3), no change (4), slightly improved (5), moderately improved (6), markedly improved (7). Higher scores mean a better outcome.
Measured: week 8 and week 16
Number of Participants Using Rescue Medicine During Weeks 1-8 and Weeks 9-16
The percentage of patients using rescue medicine will be compared between groups during weeks 1-8, and weeks 9-16. The mean frequency of using rescue medicine per week during weeks 1-8 equals the total of rescue medicine consumption divided by 8. The mean frequency of using rescue medicine per week during weeks 9-16 equals the total of rescue medicine consumption divided by 8.
Measured: weeks 1-8, and weeks 9-16
The Mean Frequency of Rescue Medicine Use Per Week During Weeks 1-8 and Weeks 9-16
The mean frequency of using rescue medicine per week during weeks 1-8 equals the total of rescue medicine consumption divided by 8. The mean frequency of using rescue medicine per week during weeks 9-16 equals the total of rescue medicine consumption divided by 8.
Measured: weeks 1-8, and weeks 9-16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start1 May 2019
- Primary completion16 Oct 2021
- Study completion11 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid-induced Constipation in Patients With CancerStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Zhishun Liu, Study chair, China Academy of Chinese Medicine Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03797586
- Sponsor's protocol ID
- 2018-164-KY-01
- Status last verified
- Jul 2025
- First submitted
- 5 Jan 2019
- Last updated
- 15 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang W, Liu Y, Yang X, Sun J, Yue Z, Lu D, Zhou K, Sun Y, Hou A, Zang Z, Jin X, Liu C, Wang Y, Yu J, Zhu L, Liu Z. Effects of Electroacupuncture for Opioid-Induced Constipation in Patients With Cancer in China: A Randomized Clinical Trial. JAMA Netw Open. 2023 Feb 1;6(2):e230310. doi: 10.1001/jamanetworkopen.2023.0310.
PubMed 36811861Wang W, Wang X, Liu Y, Sun Y, Liu X, Yan Y, Liu Z. Effects of Electroacupuncture on Opioid-Induced Constipation in Patients With Cancer: Study Protocol for a Multicenter Randomized Controlled Trial. Front Med (Lausanne). 2022 Apr 13;9:818258. doi: 10.3389/fmed.2022.818258. eCollection 2022.
PubMed 35492306
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Electroacupuncture on Opioid-induced Constipation in Patients With Cancer: Study Protocol for a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03797586
- Acronym / sponsor ID
- 2018-164-KY-01
- Keywords
- electroacupuncture；opioid-induced constipation ,cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 16 Oct 2021 (actual)
- Study completion
- 11 Dec 2021 (actual)
- First posted
- 9 Jan 2019 (actual)
- Results
- Posted 15 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Approximately 70-80% of patients with advanced disease will be affected by moderate to severe pain. Opioid analgesics represented by morphine and oxycodone are the cornerstone of cancer-pain management, and recommended for use in the management of moderate to severe cancer pain according to WHO Cancer Pain Relief Guidelines. One view is that a trial of systemic opioid therapy should be administered to all cancer patients with pain of moderate or greater severity regardless of the pain mechanism. Although opioids analgesics do work well as relieving pain and improving quality of life via their action at opioid receptors in the central nervous system (CNS) and the peripheral nervous system, they also have powerful adverse effects. The overall occurrence of opioid-related adverse drug events has ranged from1.8% to 13.6%. Opioid-induced constipation (OIC), one of the most prevalent adverse events (AEs) in patients receiving opioid analgesics, defined as a change in baseline bowel habits or defecatory patterns following initiation, alteration, or increase in opioid therapy. The prevalence of OIC has been estimated to affect 41% of patients with chronic noncancer pain taking opioids and 94% of cancer patients taking opioids for pain. Unlike many other opioid-related AEs, OIC is persistent and rarely tolerated. OIC impacts pain control, patients' quality of life and may cause patients to reduce the dose or discontinue opioid use.
Acupuncture, a traditional Chinese medicine, has been used to treat gastrointestinal disease including constipation for thousands of years. Two systematic reviews concluded that acupuncture can improve spontaneous bowel movements for functional constipation, and our recent study indicated that electroacupuncture(EA) could increase complete spontaneous bowel movements and is safe for chronic severe functional constipation. Acupuncture could improve gastrointestinal function via facilitating gastrointestinal motility. Currently, there is little detailed information available regarding the acupuncture use for OIC. The objective of this study is to assess the efficacy and safety of EA for OIC in patients with cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture group | Experimental | Other: Electroacupuncture groupBilateral ST25,SP14, ST37 will be used in the EA group. For ST25 and SP14, 0.30×50mm or 0.30×75mm needles will be vertically inserted to the muscle layer of the abdominal , where patients will feel sharp pain and acupuncturists will feel resistance from the needle tip. For ST37, 0.30×40 mm needles will be vertically inserted approximately 15 mm deep, followed by three-time manipulation of even lifting and twisting method to elicit the sensation of deqi. Then paired alligator clips of the EA apparatus will be attached to the needle holders of the bilateral ST25, SP14, and ST37. EA stimulation will be retained for 30 minutes with a continuous wave of 10 Hz and current intensity of 0.5 to 4 mA. |
| Sham electroacupuncture group | Sham comparator | Other: Sham electroacupuncture groupBilateral sham ST25, SP14, and ST37 will be used in the SA group. After sterilizing the skin, 0.30×40mm needles will be straightly inserted at the sham points about 2-3mm until they can be fixed on the skin when attached by the alligator clips. No manipulation will be used, and no deqi sensation are elicited for all sham points. The bilateral sham ST25, SP14, and ST37 points will be attached by the same EA apparatus with a continuous wave of 10 Hz and current intensity of 0.1 to 0.2 mA for 30 minutes with only the initial 30 seconds on. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Cancer patients who conformed to all the following conditions will be further screened for eligibility:
- Cancer patients must meet the Rome IV[1] diagnostic criteria for OIC: New or worsening symptoms of constipation following initiation, alteration, or increase in opioid treatment. For patients with a history of chronic functional constipation, he/she must have worsening symptoms of constipation when the opioid therapy is initiated, changed, or the dose is increased;
- Patients recruited in this trial must have a history of OIC symptoms for at least 1 week;
- Patients must be ≥18 years of age and ≤85 years of age;
- Patient's cancer condition must be stable with a life expectancy that is more than six months;
Key exclusion criteria (18 listed)
- Patients diagnosed with clinically significant abnormal defecation due to structural abnormalities of the gastrointestinal tract and other tissues related to gastrointestinal tract (not including OIC): inflammatory bowel disease, rectal prolapse, gastrointestinal obstruction, peritoneal metastasis, or peritoneal tumor at the time of enrollment;
- Patients with a history of gastrointestinal tract operation, abdominal operation, or abdominal adhesion within one month prior to screening; history of intestinal obstruction within three months prior to screening;
- Diagnosis of active diverticular disease; or severe hemorrhoid; or anal fissure; or artificial rectum or anus;
- Patients with an intraperitoneal catheter or a feeding tube;
- Diagnosis of pelvic disorder which are considered to have obvious effects on the intestinal transport of feces (such as uterine prolapse ≥degree 2, uterine fibroids [located in the posterior of the uterus with a diameter ≥ 5 cm] affecting bowel movement);
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 |
|---|---|---|
| Electroacupuncture groupBilateral Tianshu (ST25), Fujie (SP14), Shangjuxu (ST37) will be used in the EA group. With the local skin of the patients was routinely sterilized in a prone position in relaxation, acupuncturists will insert needles into the acupuncture points. For ST25 and SP14, 0.30×50mm or 0.30×75mm needles will be vertically inserted to the muscle layer of the abdominal wall, where participants will feel sharp pain and acupuncturists will feel resistance from the needle tip. For ST37, 0.30×40 mm needles will be vertically inserted approximately 15 mm deep, followed by three-time manipulation of even lifting and twisting method to elicit the sensation of deqi. Then paired alligator clips of the EA apparatus will be attached to the needle holders of the bilateral ST25, SP14, and ST37. EA stimulation will be retained for 30 minutes with a continuous wave of 10 Hz and current intensity of 0.5 to 4 mA. | Other | Electroacupuncture group |
| Sham electroacupuncture groupBilateral sham ST25, SP14, and ST37 will be used in the SA group. After sterilizing the skin, 0.30×40mm needles will be straightly inserted at the sham points about 2-3mm until they can be fixed on the skin when attached by the alligator clips. No manipulation will be used, and no deqi sensation are elicited for all sham points. The bilateral sham ST25, SP14, and ST37 points will be attached by the same EA apparatus with a continuous wave of 10 Hz and current intensity of 0.1 to 0.2 mA for 30 minutes with only the initial 30 seconds on. | Other | Sham electroacupuncture group |
Primary outcome
Number of Participants With Response
Time frame: weeks 1-8
A responder（Participant With Response） is defined as a patient that has at least three spontaneous bowel movements (SBMs) per week and an increase of at least one SBM a week from the baseline for at least 6 of the 8 weeks of the treatment period.
17 secondary outcomes
A Change in the Mean Weekly Spontaneous Bowel Movements (SBMs) From the Baseline During Weeks 1-8 and Weeks 13-16.
Time frame: weeks 1-8, and weeks 13-16
Number of Participants With ≥3 Mean Weekly Spontaneous Bowel Movements (SBMs) During Weeks 1-8
Time frame: weeks 1-8
Number of Participants With ≥3 Mean Weekly Spontaneous Bowel Movements (SBMs) During Weeks 13-16
Time frame: weeks 13-16
Number of Participants With an Increase of ≥1 Mean Weekly Spontaneous Bowel Movements (SBMs) From the Baseline During Weeks 1-8
Time frame: weeks 1-8
Number of Participants With an Increase of ≥1 Mean Weekly Spontaneous Bowel Movements (SBMs) From the Baseline During Weeks 13-16
Time frame: weeks 13-16
A Change in the Mean Weekly Complete Spontaneous Bowel Movements (CSBMs) From the Baseline During Weeks 1-8 and Weeks 13-16.
Time frame: weeks 1-8, and weeks 13-16
Number of Participants With ≥3 Mean Weekly Spontaneous Bowel Movements (CSBMs) During Weeks 1-8
Time frame: weeks 1-8
Number of Participants With ≥3 Mean Weekly Spontaneous Bowel Movements (CSBMs) During Weeks 13-16
Time frame: weeks 13-16
Number of Participants With an Increase of ≥1 Mean Weekly Spontaneous Bowel Movements (CSBMs) From the Baseline During Weeks 1-8
Time frame: weeks 1-8
Number of Participants With an Increase of ≥1 Mean Weekly Spontaneous Bowel Movements (CSBMs) From the Baseline During Weeks 13-16
Time frame: weeks 13-16
A Change in the Mean Bristol Stool Form Scale Score for Stool Consistency of Spontaneous Bowel Movements (SBMs) From the Baseline During Weeks 1-8 and Weeks 13-16
Time frame: weeks 1-8, and weeks 13-16
A Change in the Mean Score for the Straining of Spontaneous Bowel Movements (SBMs) From the Baseline During Weeks 1-8 and Weeks 13-16
Time frame: weeks 1-8, and weeks 13-16
A Change in the Total Score of the Patient Assessment of Constipation-Symptom (PAC-SYM) Questionnaire From Baseline at Weeks 8 and 16
Time frame: week 8 and week 16
A Change in the Total Scores of the Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaires From the Baseline at Weeks 8 and 16
Time frame: week 8 and week 16
Patients'Global Assessment of Treatment Efficacy
Time frame: week 8 and week 16
Number of Participants Using Rescue Medicine During Weeks 1-8 and Weeks 9-16
Time frame: weeks 1-8, and weeks 9-16
The Mean Frequency of Rescue Medicine Use Per Week During Weeks 1-8 and Weeks 9-16
Time frame: weeks 1-8, and weeks 9-16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36811861Wang W, Liu Y, Yang X, Sun J, Yue Z, Lu D, Zhou K, Sun Y, Hou A, Zang Z, Jin X, Liu C, Wang Y, Yu J, Zhu L, Liu Z. Effects of Electroacupuncture for Opioid-Induced Constipation in Patients With Cancer in China: A Randomized Clinical Trial. JAMA Netw Open. 2023 Feb 1;6(2):e230310. doi: 10.1001/jamanetworkopen.2023.0310.
- Derived from this study: PubMed 35492306Wang W, Wang X, Liu Y, Sun Y, Liu X, Yan Y, Liu Z. Effects of Electroacupuncture on Opioid-Induced Constipation in Patients With Cancer: Study Protocol for a Multicenter Randomized Controlled Trial. Front Med (Lausanne). 2022 Apr 13;9:818258. doi: 10.3389/fmed.2022.818258. eCollection 2022.
- Individual participant dataSharing planned: No
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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.
Zhishun Liu study chair
China Academy of Chinese Medicine Sciences
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 group in people with Opioid-induced Constipation in Patients With Cancer, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences 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 10 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 15 Jul 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?
Yes. Results are posted in the registry (first posted 15 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Response (time frame: weeks 1-8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03797586, which also lists 2 linked publications.
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 15 Jul 2025.