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

Study Overview
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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.

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

Conditions
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Resectable Colorectal Carcinoma, Resectable Digestive System Carcinoma, Resectable Pancreatic Carcinoma

Intervention / Treatment
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* Procedure: Acupuncture Therapy
* Other: Best Practice
* Other: Questionnaire Administration


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (acupuncture, usual care)<br>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<br>* Undergo acupuncture<br>* Other names: Acupuncture;Other: Best Practice<br>* Undergo usual care<br>* Other names: standard therapy;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Active Comparator: Arm II (usual care)<br>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<br>* Undergo usual care<br>* Other names: standard therapy;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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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 |