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

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ClinicalTrials.gov Identifier: NCT04560712
Recruitment Status : Recruiting
First Posted : September 23, 2020
Last Update Posted : September 23, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Resectable Colorectal Carcinoma Resectable Digestive System Carcinoma Resectable Pancreatic Carcinoma Procedure: Acupuncture Therapy Other: Best Practice Other: Questionnaire Administration Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Integrating Acupuncture Into Postoperative Pain Management in Patients Undergoing Open Abdominal Operations
Actual Study Start Date : August 12, 2020
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

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.
Procedure: Acupuncture Therapy
Undergo acupuncture
Other Name: Acupuncture

Other: Best Practice
Undergo usual care
Other Names:
  • standard of care
  • standard therapy

Other: Questionnaire Administration
Ancillary studies

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: Best Practice
Undergo usual care
Other Names:
  • standard of care
  • standard therapy

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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

  3. 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"


Other Outcome Measures:
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04560712


Contacts
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Contact: Wenli Liu 713-745-4469 wenliliu@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Wenli Liu    713-745-4469      
Principal Investigator: Wenli Liu         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Wenli Liu M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04560712    
Other Study ID Numbers: 2020-0234
NCI-2020-05225 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2020-0234 ( Other Identifier: M D Anderson Cancer Center )
First Posted: September 23, 2020    Key Record Dates
Last Update Posted: September 23, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Carcinoma
Colorectal Neoplasms
Pancreatic Neoplasms
Pain, Postoperative
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases