Acupuncture in Reducing Ileus in Patients Who Have Undergone Surgery for Colorectal Cancer - Full Text View

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00425412

Purpose

RATIONALE: Acupuncture may help lessen ileus caused by colon surgery.

PURPOSE: This randomized phase II trial is studying acupuncture to see how well it reduces ileus compared with sham acupuncture in patients who have undergone surgery for colorectal cancer.

Condition	Intervention	Phase
Cancer-Related Problem/Condition Colorectal Cancer Nausea and Vomiting Pain	Procedure: acupuncture therapy Procedure: sham intervention	Phase II

MedlinePlus related topics: Acupuncture Cancer Colorectal Cancer Nausea and Vomiting

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Placebo Control
Official Title:	A Phase II Randomized Controlled Trial of Acupuncture for Reduction of Post-Colectomy Ileus

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Time to recovery of gastrointestinal (GI) function (GI-3), as defined by the time the patient first tolerates solid food, or the time the patient first passes flatus or has a bowel movement, whichever occurs later [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to recovery of GI function (GI-2), as defined by the time the patient first tolerates solid food, or the time the patient first passes a bowel movement, whichever occurs later [ Designated as safety issue: No ]
GI contractions as measured by a multifunctional stethoscope [ Designated as safety issue: No ]
Daily pain score [ Designated as safety issue: No ]
Opioid consumption (total dose of morphine equivalent during hospitalization and average dose per day) [ Designated as safety issue: No ]
Need for postoperative nasogastric tube [ Designated as safety issue: No ]
Severity of nausea as defined by the number of requests for PRN antiemetics and a visual analog scale [ Designated as safety issue: No ]
Number of emetic episodes during the hospital stay [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	November 2006
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I (acupuncture): Experimental Patients undergo acupuncture over 30 minutes twice daily on days 1-3 after surgery. Electrical stimulation is applied to 2 pairs of acupuncture points.	Procedure: acupuncture therapy Given over 30 minutes twice daily for 3 days after surgery
Arm II (sham acupuncture): Sham Comparator Patients undergo sham acupuncture over 30 minutes twice daily on days 1-3 after surgery.	Procedure: sham intervention Given over 30 minutes twice daily for 3 days after surgery

Detailed Description:

OBJECTIVES:

Primary

Determine whether a phase III study of acupuncture for postoperative recovery after colorectal surgery is warranted, as defined by evidence of reduction of postoperative ileus in patients who undergo acupuncture vs sham acupuncture after segmental or subtotal colectomy with primary anastomosis for colorectal cancer.

Secondary

Determine whether acupuncture reduces the length of hospital stay more than sham acupuncture.
Determine whether acupuncture improves patient satisfaction with the hospital experience by ameliorating other postoperative symptoms, such as pain, nausea, and vomiting.
Determine the feasibility of a phase III trial, in terms of sample size, accrual rate, attrition rate, and data completion.

OUTLINE: This is a randomized, prospective, placebo-controlled study. Patients are stratified according to type of colectomy (segmental vs subtotal). Patients are randomized to 1 of 2 treatment arms.

Arm I (acupuncture): Patients undergo acupuncture over 30 minutes twice daily on days 1-3 after surgery. Electrical stimulation is applied to 2 pairs of acupuncture points.
Arm II (sham acupuncture): Patients undergo sham acupuncture over 30 minutes twice daily on days 1-3 after surgery.

Bowel function, pain, and nausea and vomiting are assessed daily until hospital discharge. Patients complete two treatment-related questionnaires after completion of study therapy.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed or suspected colorectal cancer
Has undergone elective segmental or subtotal colectomy with primary anastomosis
- No requirement for ileostomy or colostomy
- No resection incorporating the upper gastrointestinal tract
- No gross fecal spillage
- No complications during surgery requiring a patient's transfer to the Intensive Care Unit (ICU) directly from the operating room or Post Anesthesia Care Unit (PACU)
  - Patients who are transferred to the floor first and who subsequently require transfer to ICU are eligible
- No requirement for leaving the intraoperative nasogastric tube in place
- No postoperative epidural anesthetics or epidural opioids

PATIENT CHARACTERISTICS:

No prior serious adverse event with acupuncture
No contraindication to use of electrical stimulation, including cardiac pacemaker and implantable cardioverter defibrillator

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior major abdominal or pelvic surgery
- Prior uncomplicated appendectomy, cholecystectomy, or hysterectomy performed more than 3 years ago allowed
No prior laparoscopic procedure
No acupuncture within the past 4 weeks
No concurrent epidural anesthetics or epidural opioids

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425412

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center	Recruiting
New York, New York, United States, 10021
Contact: Gary E. Deng, MD, PhD 212-639-4956

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:	Gary E. Deng, MD, PhD	Memorial Sloan-Kettering Cancer Center
Principal Investigator:	W. Douglas Wong, MD	Memorial Sloan-Kettering Cancer Center
Principal Investigator:	Barrie R. Cassileth, PhD	Memorial Sloan-Kettering Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Gary E. Deng )
Study ID Numbers:	CDR0000525776, MSKCC-06145
Study First Received:	January 19, 2007
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00425412
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

nausea and vomiting
pain
gastrointestinal complications
perioperative/postoperative complications
stage III colon cancer
stage IV colon cancer
stage III rectal cancer

stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
stage I colon cancer
stage II colon cancer
stage I rectal cancer
stage II rectal cancer

Study placed in the following topic categories:

Vomiting
Digestive System Neoplasms
Signs and Symptoms, Digestive
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Pain
Intestinal Diseases
Rectal Diseases
Recurrence

Intestinal Neoplasms
Rectal neoplasm
Signs and Symptoms
Ileus
Digestive System Diseases
Postoperative Complications
Gastrointestinal Neoplasms
Nausea
Rectal cancer
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009