Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
The purpose of this study is to see whether acupuncture may help patients recover from colon cancer surgery.
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Acupuncture is the insertion of needles at certain body points. |
|
| 2 | Sham Comparator | sham acupuncture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine whether a Phase III trial of acupuncture for postoperative recovery after colorectal surgery is warranted as defined by evidence of reduction of postoperative ileus when compared to sham acupuncture | end of study |
| Measure | Description | Time Frame |
|---|---|---|
| To explore whether acupuncture improves patient satisfaction with the hospital experience by ameliorating other postoperative symptoms such as pain and nausea and vomiting | daily pain score, opioids consumption (total dose of morphine equivalent during hospitalization and average dose per day) severity of nausea as defined by number of request for PRNantiemetics, and number of emetic episodes during hospital stay. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Pre-operative factors:
History of major abdominal or pelvic surgery that have caused significant alteration in anatomy and function of the GI tract which may affect the endpoints of this study.
Laparoscopic procedures. They tend to result in less postoperative ileus.
Administration of epidural anesthetics or epidural opioids: these have previously been shown to affect postoperative GI motility. They made up only 5% of colectomy patients in the investigators' institution.
Acupuncture within the last 4 weeks (to exclude any possible residual effect from acupuncture)
Contraindications to use of electrical stimulation, including cardiac pacemaker and implantable cardioverter defibrillator (ICD)
Prior serious adverse event with acupuncture
Intra-operative events (these events alter the postoperative recovery course significantly):
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gary Deng, MD, PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center 1275 York Avenue | New York | New York | 10021 | United States |
Not provided
| Label | URL |
|---|---|
| Memorial Sloan-Kettering Cancer Center | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D010149 | Pain, Postoperative |
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Sham Acupuncture | Other | 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, |
|
| To determine the feasibility of a Phase III trial in terms of sample size, accrual rate, attrition rate and data completion | end of study |
| GI-2, (also representing time to recovery of gastrointestinal [GI] function) | patient first tolerated solid food,and time patient first passed a bowel movement |
| GI contractions measured with a multifunctional stethoscope | duration of two minute before and immediately after each true or sham acupuncture treatment. |
| Daily pain score | daily during hospitalization |
| Opioid consumption (total dose of morphine equivalent during hospitalization and average dose per day) | daily pain score, opioids consumption (total dose of morphine equivalent during hospitalization and average dose per day) severity of nausea as defined by number of request for PRNantiemetics, and number of emetic episodes during hospital stay. |
| Number of emetic episodes during hospital stay | assement daily |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D014839 | Vomiting |