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

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-12

Study Completion Date

2027-12-31

Brief Summary

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This trial investigates how well acupuncture works for the management of pain after surgery in patients having open colorectal or pancreatic surgery. Acupuncture may help to reduce postoperative symptoms including pain. This study may help researchers learn if acupuncture reduces after-surgery side effects and improves recovery.

Detailed Description

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PRIMARY OBJECTIVE:

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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Resectable Colorectal Carcinoma Resectable Digestive System Carcinoma Resectable Pancreatic Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

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.

Group Type EXPERIMENTAL

Acupuncture Therapy

Intervention Type PROCEDURE

Undergo acupuncture

Best Practice

Intervention Type OTHER

Undergo usual care

Questionnaire Administration

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Undergo usual care

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Acupuncture Therapy

Undergo acupuncture

Intervention Type PROCEDURE

Best Practice

Undergo usual care

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Acupuncture standard of care standard therapy

Eligibility Criteria

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Inclusion Criteria

* Undergoing open gastrointestinal cancer resection (pancreatic or colorectal)
* Must understand and read English
* Sign a written informed consent and willing to follow protocol requirements
* Able to consent to treatment

Exclusion Criteria

* Chronic opioid use \> 90 mg MME (morphine milligram equivalents) for more than 7 days
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Related Links

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http://www.mdanderson.org

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