Pain Clinical Trial
Official title:
The Effects of Soy Protein Supplementation on Post-thoracotomy Pain
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 protein prior to and following a thoracotomy for a lung tumor. We are especially interested in pain severity and pain medication use following surgery and will measure function and quality of life.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Medical Institutions | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Center for Complementary and Integrative Health (NCCIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | pain severity | |||
Primary | pain medication use | |||
Secondary | function | |||
Secondary | health-related quality of life |
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