Acupuncture for the Management of Postoperative Pain in Patients With Pancreatic or Colorectal Cancer Undergoing Surgery

NCT04560712 | Active Not Recruiting DMC FDA Device

• 2 other identifiers: 2020-0234NCI-2020-05225
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Resectable Colorectal Carcinoma; Resectable Digestive System Carcinoma; Resectable Pancreatic Carcinoma

Outcome Measures

Primary Outcomes (3)

• Adherence rate to daily acupuncture

  Acupuncturist will document in the medical record all the treatments participants are completing and also document if missing any treatments.

  Up to 7 days

• Compliance

  Acupuncturist and research coordinator will document in EPIC if participant is compliant with acupuncture sessions (study intervention) and with study questionnaires.

  Up to 7 days

• Retention

  Will be measured as percentage of patients who complete the study out of the number of patients after study randomization.

  Up to 7 days

Secondary Outcomes (3)

• Postoperative opioid use for pain management

  24 hours

• Pain levels

  Up to 7 days

• Satisfaction of pain control

  Up to 7 days

Other Outcomes (2)

• Dietary recovery

  Up to 7 days

• Postoperative length of stay

  Up to 7 days

Study Arms (2)

Arm I (acupuncture, usual care)

EXPERIMENTAL

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.

Procedure: Acupuncture Therapy; Other: Best Practice; Other: Questionnaire Administration

Arm II (usual care)

ACTIVE COMPARATOR

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.

Other: Best Practice; Other: Questionnaire Administration

Interventions

Acupuncture Therapy PROCEDURE

Undergo acupuncture

Also known as: Acupuncture

Arm I (acupuncture, usual care)

Best Practice OTHER

Undergo usual care

Also known as: standard of care, standard therapy

Arm I (acupuncture, usual care); Arm II (usual care)

Questionnaire Administration OTHER

Ancillary studies

Arm I (acupuncture, usual care); Arm II (usual care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• http://www.mdanderson.org

MeSH Terms

Interventions

Acupuncture Therapy; Practice Guidelines as Topic; Standard of Care

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Officials

• Lorenzo Cohen

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: September 23, 2020
• Study Start: August 12, 2020
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

US (1)