NCT00344097

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 26, 2006

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

March 22, 2013

Status Verified

March 1, 2013

Enrollment Period

4 years

First QC Date

June 23, 2006

Last Update Submit

March 21, 2013

Conditions

ThoracotomyPain

Keywords

soy proteinpainthoracotomy

Outcome Measures

Primary Outcomes (2)

  • pain severity

  • pain medication use

Secondary Outcomes (2)

  • function

  • health-related quality of life

Interventions

Soy proteinPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Medical Institutions

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Soybean Proteins

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant ProteinsProteinsAmino Acids, Peptides, and ProteinsPlant Proteins, DietaryDietary ProteinsFoodDiet, Food, and NutritionPhysiological PhenomenaSoy FoodsVegetable ProductsVegetablesFood and Beverages

Study Officials

  • Jennifer A. Haythornthwaite, Ph.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2006

First Posted

June 26, 2006

Study Start

March 1, 2006

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

March 22, 2013

Record last verified: 2013-03

Locations

US(1)