CompletedNot Applicable

Effect of Electroacupuncture on Opioid-induced Constipation in Patients With Cancer

China100 participantsStarted 2019-05-01

Plain-language 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 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.

Who can participate

Age range18 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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;
✓. 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;

What they're measuring

Number of Participants With Response

Timeframe: weeks 1-8

Trial details

NCT IDNCT03797586

SponsorGuang'anmen Hospital of China Academy of Chinese Medical Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-10-16

Results submitted2022-08-07

View on ClinicalTrials.gov More Opioid-induced Constipation in Patients With Cancer trials

Plain-language summary

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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;
✓. 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;

Effect of Electroacupuncture on Opioid-induced Constipation in Patients With Cancer

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Effect of Electroacupuncture on Opioid-induced Constipation in Patients With Cancer

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Exclusion criteria