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Acupuncture for Postoperative Pain in Cancer Surgery

N/A

Waitlist Available

Led By Lorenzo Cohen

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergoing open gastrointestinal cancer resection (pancreatic or colorectal)

Be older than 18 years old

Must not have

Mechanical bowel obstruction

Any contraindications to acupuncture including infections or inability to access acupoint sites

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours

Awards & highlights

No Placebo-Only Group

Summary

This trialis exploring if acupuncture can help reduce pain and other symptoms after open colorectal or pancreatic surgery. It may lead to better recovery and fewer side effects.

Who is the study for?

This trial is for English-speaking patients with pancreatic or colorectal cancer who are undergoing open surgery. They must be able to consent and follow the study's rules. People using high doses of opioids, those with bowel obstruction, recent major surgery, seizures, cognitive issues, or conditions preventing acupuncture can't join.

What is being tested?

The study is testing if acupuncture can manage pain after pancreatic or colorectal surgery better than usual care practices. Patients will receive acupuncture therapy alongside standard postoperative procedures and their pain levels will be monitored through questionnaires.

What are the potential side effects?

Acupuncture may cause minor side effects such as slight bleeding, bruising at needle sites, nausea, or dizziness. Most people find it a low-risk procedure that doesn't have serious complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am having surgery for pancreatic or colorectal cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a blockage in my intestines.

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I have no infections or issues that prevent acupuncture.

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I will not be admitted to the ICU immediately after my surgery.

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I have had seizures after being admitted to the hospital.

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I had surgery in my belly area within the last 6 months.

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I have been using opioids equivalent to more than 90 mg of morphine daily for over a week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence rate to daily acupuncture

Compliance

Retention

Secondary study objectives

Pain levels

Postoperative opioid use for pain management

Satisfaction of pain control

Other study objectives

Dietary recovery

Postoperative length of stay

Side effects data

From 2022 Phase 2 trial • 45 Patients • NCT04496219

62%

Urinary Symptoms

58%

Fatigue

38%

Headache

35%

Bowel Symptoms

35%

Flu-like Symptoms

35%

Hematuria

31%

Other

27%

Pain

Bruise

100%

80%

60%

40%

20%

Study treatment Arm

Arm I (Acupuncture, BCG)

Arm II (BCG, Standard of Care)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (acupuncture, usual care)Experimental Treatment3 Interventions

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 II: Arm II (usual care)Active Control2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acupuncture Therapy

2018

Completed Phase 2

~260

0 / 7Eligibility criteria met