Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00344097
Other study ID # R21 AT003613
Secondary ID
Status Withdrawn
Phase Phase 2
First received June 23, 2006
Last updated March 21, 2013
Start date March 2006
Est. completion date March 2010

Study information

Verified date March 2013
Source National Center for Complementary and Integrative Health (NCCIH)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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 soy/placebo supplement 2-3 days prior to thoracotomy and continue daily consumption of the supplement for an additional period following surgery. The feasibility/pilot 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.


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Soy protein


Locations

Country Name City State
United States Johns Hopkins Medical Institutions Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary pain severity
Primary pain medication use
Secondary function
Secondary health-related quality of life
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05559255 - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI N/A
Completed NCT04748367 - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care N/A
Terminated NCT04356352 - Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain Phase 2/Phase 3
Completed NCT05057988 - Virtual Empowered Relief for Chronic Pain N/A
Completed NCT04466111 - Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
Recruiting NCT06206252 - Can Medical Cannabis Affect Opioid Use?
Completed NCT05868122 - A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy Phase 3
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Completed NCT03273114 - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain N/A
Enrolling by invitation NCT06087432 - Is PNF Application Effective on Temporomandibular Dysfunction N/A
Completed NCT05508594 - Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001 Phase 2/Phase 3
Recruiting NCT03646955 - Partial Breast Versus no Irradiation for Women With Early Breast Cancer N/A
Active, not recruiting NCT03472300 - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Completed NCT03678168 - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries N/A
Completed NCT03931772 - Online Automated Self-Hypnosis Program N/A
Completed NCT03286543 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System N/A
Completed NCT02913027 - Can We Improve the Comfort of Pelvic Exams? N/A
Terminated NCT02181387 - Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor? Phase 4
Recruiting NCT06032559 - Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment Phase 3
Active, not recruiting NCT03613155 - Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care