Effect of Electroacupuncture on Opioid-induced Constipation in Patients With Cancer
Condition: Opioid-induced Constipation in Patients With Cancer
MeSH terms: Constipation; Opioid-Induced Constipation
Study type: Interventional

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.
    


Intervention name(s): Electroacupuncture group; Sham electroacupuncture group
Intervention type(s): Other; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: electroacupuncture；opioid-induced constipation ,cancer