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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Institutes of Health (NIH) |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00402961 |
The purpose of this study is to see whether acupuncture may help patients recover from colon cancer surgery.
Condition | Intervention | Phase |
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Postoperative Ileus Colon Cancer Pain, Postoperative Postoperative Nausea and Vomiting |
Other: Acupuncture Other: Sham Acupuncture |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | A Phase II Randomized Controlled Trial of Acupuncture for Reduction of Post-Colectomy Ileus |
Estimated Enrollment: | 80 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Acupuncture is the insertion of needles at certain body points.
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Other: Acupuncture
Acupuncture will be given twice daily for a total of three days (Day 1 to 3). The two acupuncture sessions will be separated by at least 4 hours, preferably given in the morning and late afternoon. Each session will last approximately 30 minutes, starting from the moment the first needle is inserted and ending the moment the first needle is removed. The last treatment will be given at the end of Day 3 or day of discharge.
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2: Sham Comparator
sham acupuncture
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Other: Sham Acupuncture
Sham Acupuncture involves the acupuncturist tapping a plastic guiding tube on the surface of the true points to produce some discernible sensation and then immediately tapping a real needle sideways parallel to the skin surface without needle insertion. It will be given twice daily for a total of three days (Day 1 to 3). The two acupuncture sessions will be separated by at least 4 hours, preferably given in the morning and late afternoon. Each session will last approximately 30 minutes, starting from the moment the first needle is inserted and ending the moment the first needle is removed. The last treatment will be given at the end of Day 3 or day of discharge,
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Postoperative ileus contributes to prolonged hospital stay, readmission and postoperative morbidities in patients undergoing major abdominal surgery. Reduction of postoperative ileus is important in postoperative recovery. Postoperative pain may require opioids, which further reduce gastrointestinal (GI) motility. Postoperative nausea and vomiting hamper the resumption of oral intake. Together, these three common postoperative problems contribute to patient discomfort, delayed discharge and increased overall hospitalization costs, despite current multi-modal management options. Any safe and effective therapy in addition to current standard of care would be welcomed by patients, surgeons and hospitals.
Acupuncture is a complementary medicine modality shown to reduce postoperative pain, suppress nausea and vomiting, and promote GI motility. It is associated with few adverse events. Here we propose a randomized, sham controlled phase II study to evaluate acupuncture, in addition to conventional therapy, for its safety and effectiveness in improving postoperative recovery of colorectal cancer patients undergoing segmental or subtotal colectomy. The overall objective of this developmental project is to determine whether a more extended research project is warranted.
The specific aims are:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Pre-operative factors:
Intra-operative events (these events alter the postoperative recovery course significantly):
Contact: Gary Deng, MD, PhD | 212-639-4956 | dengg@mskcc.org |
Contact: Barrie Cassileth, PhD | 212-639-8629 | cassileth@mskcc.org |
United States, New York | |
Memorial Sloan-Kettering Cancer Center 1275 York Avenue | Recruiting |
New York, New York, United States, 10021 | |
Contact: Gary Deng, MD, PhD 212-639-4956 dengg@mskcc.org | |
Contact: Barrie Cassileth, PhD 212-639-8629 cassileth@mskcc.org |
Principal Investigator: | Gary Deng, MD, PhD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan Kettering Cancer Center ( Gary Deng, MD ) |
Study ID Numbers: | 06-145 |
Study First Received: | November 22, 2006 |
Last Updated: | October 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00402961 |
Health Authority: | United States: Institutional Review Board |
Acupuncture Post-Colectomy Ileus Abdominal Surgery Colon Surgery |
Postoperative Nausea and Vomiting Vomiting Digestive System Neoplasms Signs and Symptoms, Digestive Gastrointestinal Diseases Colonic Diseases Pain Intestinal Diseases Intestinal Neoplasms Intestinal Obstruction |
Signs and Symptoms Ileus Digestive System Diseases Postoperative Complications Gastrointestinal Neoplasms Nausea Colonic Neoplasms Pain, Postoperative Colorectal Neoplasms |
Neoplasms Pathologic Processes Neoplasms by Site |