Status:
WITHDRAWN
The Effects of Soy Protein on Post-thoracotomy Pain
Lead Sponsor:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Thoracotomy
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study seeks to determine whether soy protein supplements reduce the pain that often occurs following surgery for a lung tumor. Patients are randomized to receive either soy protein or milk protei...
Detailed Description
Preclinical studies indicate that soy-containing diets suppress the development of pain behaviors and hyperalgesia seen following nerve injury and recent data indicate a similar protective effect of a...
Eligibility Criteria
Inclusion
- Inclusion criteria: 1) undergoing major elective thoracotomy through a classic incision, including segmentectomy, lobectomy, or wedge resection, 2) for women, a negative mammogram within the past year; 3) for women using oral contraceptives or hormone replacement therapy, the agreement to hold steady dosing of these medications for the duration of the study; and 4) ability to comprehend the consent information and to complete all study assessments.
- Exclusion criteria: 1) age less than 18 years, 2) current alcohol or substance abuse/dependence; 3) delirium, dementia, or cognitive impairment (MMSE \< 24; (23)); 4) use of analgesics (other than aspirin or non-steroidal anti-inflammatories) for a condition other than the reason for surgery; 5) milk or soy allergy; 6) lactose intolerance; 7) pre-operative chest pain; 8) women with a history of breast cancer; or 9) \[use of an antibiotic within 3 months prior to surgery.
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00344097
Start Date
March 1 2006
End Date
March 1 2010
Last Update
March 22 2013
Active Locations (1)
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1
Johns Hopkins Medical Institutions
Baltimore, Maryland, United States, 21205