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

Integrating Acupuncture Into Postoperative Pain Management in Patients Undergoing Open Abdominal Operations

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Resectable Pancreatic Carcinoma; Resectable Colorectal Carcinoma; Resectable Digestive System Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Procedure: Acupuncture Therapy; Other: Best Practice

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Questionnaire Administration; Ancillary studies; Procedure: Acupuncture Therapy; Undergo acupuncture; Other Names: Acupuncture; Other: Best Practice; Undergo usual care; Other Names: standard of care; standard therapy
Active Comparator: 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.	Other: Questionnaire Administration; Ancillary studies; Other: Best Practice; Undergo usual care; Other Names: standard of care; standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative opioid use for pain management	Will be compared between acupuncture and standard care groups. Will estimate the mean difference and 95% confidence interval (CI). Secondary analyses will be performed using analysis of covariance by adjusting for the postoperative opioid requirement for the first 24 hours (and/or other relevant patient characteristics).	24 hours
Pain levels	Pain will be measured by the MD Anderson Symptom Inventory (MDASI) core symptoms to obatain data on satisfaction of pain control and other symptom mamgement starting on PDO1 and then every other day until discharge	Up to 7 days
Satisfaction of pain control	The satisfaction of pain control will be assessed using the MD Anderson Symptom Inventory (MDASI). The MDASI consists of a core list of symptoms that are common across all cancer diagnoses and treatments [15]. Participants will rate the intensity of physical, affective, and cognitive symptoms on a 0 to 10 numeric scale from "not present" to "as bad as you can imagine." Participants will also rate the amount of interference with daily activities caused by symptoms on a 0 to 10 numeric scale from "did not interfere" to "interfere completely"	Up to 7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary recovery	The dietary recovery will be obtained from the notes the dietitian documents in the medical record. Participants recovery is directly related to how fast they start eating a normal diet after surgery.	Up to 7 days
Postoperative length of stay	Will be compared between acupuncture and standard care groups. Will estimate the mean difference and 95% CI.	Up to 7 days

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Lorenzo Cohen, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• http://www.mdanderson.org

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2020
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: July 27, 2020
• First Submitted That Met QC Criteria: September 21, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Estimated): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Intestinal Diseases; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Neoplasms, Glandular and Epithelial; Colonic Diseases; Carcinoma; Colorectal Neoplasms; Pancreatic Neoplasms; Health Services Administration; Health Care Quality, Access, and Evaluation; Therapeutics; Quality of Health Care; Complementary Therapies; Quality Indicators, Health Care; Guidelines as Topic; Quality Assurance, Health Care; Standard of Care; Practice Guidelines as Topic; Acupuncture Therapy
• Other Study ID Numbers: 2020-0234 (Other Identifier: M D Anderson Cancer Center); NCI-2020-05225 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes