Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00344097
Status:
WITHDRAWN
Last Update Posted:
2013-03-22
First Post:
2006-06-23
Brief Title:
The Effects of Soy Protein on Post-thoracotomy Pain
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
The Effects of Soy Protein Supplementation on Post-thoracotomy Pain
Status:
WITHDRAWN
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 diet high in soy protein in inflammatory and bone cancer pain models These studies further indicate that soy exposure is only protective when administered in the period immediately preceding injury Very few studies have directly studied the effects of soy-containing diets on pain sensitivity in humans but one recent randomized clinical trial suggests that dietary soy supplementation may reduce pain due to osteoarthritis The proposed study will examine whether a soy protein supplement reduces the pain commonly experienced following thoracotomy for lung surgery This is a useful clinical model for studying the effects of soy protein supplementation on pain because the pain associated with surgery is quite severe and is one of the greatest concerns patients have about undergoing surgery The growing recognition that greater acute pain leads to persistent pain following tissue healing underscores the importance of identifying viable strategies including both non-pharmacological as well as pharmacological for reducing the acute pain associated with surgery Using a 2 group soy protein supplementation vs matched milk placebo supplementation design patients undergoing elective major open thoracotomy for segmentectomy lobectomy or bilobectomy will be randomly assigned to one of these two treatment groups Patients will begin taking the soyplacebo supplement 2-3 days prior to thoracotomy and continue daily consumption of the supplement for an additional period following surgery The feasibilitypilot study will examine the effects of soy supplementation on outcome measures during three post-operative time periods 1 the immediate post-operative period 2 during 2-12 weeks following surgery and 3 during 14-24 weeks following surgery Pain is the primary outcome domain of interest in this pilot study and measures will include pain severity ratings and pain medication use Function and quality of life are the secondary outcome domains of interest and measures will include pain-related interference with daily activities sleep and health-related quality of life Outcome measures will be collected bi-weekly throughout the study The study aims to determine the feasibility and acceptability of soy supplementation in the period surrounding thoracotomy determine level of adherence to soy supplementation over the 6-month period of follow-up and estimate the effect size of soy supplementation relative to placebo in reducing significant pain following thoracotomy The proposed study will provide the necessary groundwork to move towards such a larger randomized trial to evaluate the pain-reducing effects of soy protein supplementation following thoracotomy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None