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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04560712
Other study ID # 2020-0234
Secondary ID NCI-2020-0522520
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 12, 2020
Est. completion date December 31, 2025

Study information

Verified date April 2024
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 70
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Procedure:
Acupuncture Therapy
Undergo acupuncture
Other:
Best Practice
Undergo usual care
Questionnaire Administration
Ancillary studies

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other 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
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
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External Links