Acupuncture for the Management of Postoperative Pain in Patients With Pancreatic or Colorectal Cancer Undergoing Surgery
NCT ID: NCT04560712
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
70 participants
INTERVENTIONAL
2020-08-12
2027-12-31
Brief Summary
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Detailed Description
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I. Determine the feasibility of providing postoperative acupuncture for patients undergoing open colorectal or pancreatic surgery.
SECONDARY OBJECTIVE:
I. Compare postoperative opioid use for pain management, pain levels, and satisfaction of pain control between acupuncture and standard care groups.
EXPLORATORY OBJECTIVE:
I. Compare dietary recovery and postoperative length of stay between acupuncture and standard care groups.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (ACUPUNCTURE): Beginning the day after surgery, patients undergo acupuncture sessions over 25 minutes once daily (QD) for up to 7 days. Patients also undergo usual care including preoperative visits to the primary surgical team, anesthesia preoperative evaluation, referrals to other specialties for perioperative evaluation and optimization of comorbid conditions if necessary, surgical operations, postoperative hospitalization, and post-discharge clinic visits.
ARM II (USUAL CARE): Patients undergo usual care including preoperative visits to the primary surgical team, anesthesia preoperative evaluation, referrals to other specialties for perioperative evaluation and optimization of comorbid conditions if necessary, surgical operations, postoperative hospitalization, and post-discharge clinic visits.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I (acupuncture, usual care)
Beginning the day after surgery, patients undergo acupuncture sessions over 25 minutes QD for up to 7 days. Patients also undergo usual care including preoperative visits to the primary surgical team, anesthesia preoperative evaluation, referrals to other specialties for perioperative evaluation and optimization of comorbid conditions if necessary, surgical operations, postoperative hospitalization, and post-discharge clinic visits.
Acupuncture Therapy
Undergo acupuncture
Best Practice
Undergo usual care
Questionnaire Administration
Ancillary studies
Arm II (usual care)
Patients undergo usual care including preoperative visits to the primary surgical team, anesthesia preoperative evaluation, referrals to other specialties for perioperative evaluation and optimization of comorbid conditions if necessary, surgical operations, postoperative hospitalization, and post-discharge clinic visits.
Best Practice
Undergo usual care
Questionnaire Administration
Ancillary studies
Interventions
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Acupuncture Therapy
Undergo acupuncture
Best Practice
Undergo usual care
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must understand and read English
* Sign a written informed consent and willing to follow protocol requirements
* Able to consent to treatment
Exclusion Criteria
* Mechanical bowel obstruction
* Active seizure activity after admission
* Compromised cognitive function per referring physician and/or inability to cooperate with acupuncture procedure
* Direct admission to intensive care unit after operation will result in removal from protocol
* Prior intra-abdominal operation in the past 6 months
* Any contraindications to acupuncture including infections or inability to access acupoint sites
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Lorenzo Cohen
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Related Links
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http://www.mdanderson.org
Other Identifiers
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NCI-2020-05225
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-0234
Identifier Type: OTHER
Identifier Source: secondary_id
2020-0234
Identifier Type: -
Identifier Source: org_study_id