- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04560712
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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)
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.
|
Ancillary studies
Undergo acupuncture
Other Names:
Undergo usual care
Other Names:
|
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.
|
Ancillary studies
Undergo usual care
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence rate to daily acupuncture
Time Frame: Up to 7 days
|
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
Time Frame: Up to 7 days
|
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
Time Frame: Up to 7 days
|
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
Time Frame: 24 hours
|
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).
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24 hours
|
Pain levels
Time Frame: Up to 7 days
|
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
Time Frame: Up to 7 days
|
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
Time Frame: Up to 7 days
|
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
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Postoperative length of stay
Time Frame: Up to 7 days
|
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
Collaborators
Investigators
- Principal Investigator: Lorenzo Cohen, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Endocrine System Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Endocrine Gland Neoplasms
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Pancreatic Diseases
- Pain, Postoperative
- Carcinoma
- Colorectal Neoplasms
- Pancreatic Neoplasms
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
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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