Status:
COMPLETED
PASSION - P Trial: Ph Adjusted Sulfur-Colloid, Sentinel Initiative ON Pain Trial
Lead Sponsor:
Walter Reed Army Medical Center
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
Patients with breast cancer scheduled to undergo sentinel lymph node mapping and biopsy will be randomly assigned to one of four treatment groups: I: (Standard of Care at WRAMC): Application of L-M-X...
Detailed Description
Null hypothesis: There is no difference in overall pain intensity between standard and pH adjusted radiocolloid for patients undergoing sentinel lymph node mapping and biopsy for breast cancer. Objec...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Female military healthcare beneficiaries should be over 18 years of age and capable of providing informed consent indicating awareness of the investigational nature of this trial, in keeping with institutional policy.
- Written informed consent must be obtained from each patient prior to entering the study.
- Female military healthcare beneficiaries with early breast cancer scheduled to undergo sentinel lymph node mapping and biopsy at WRAMC
- Exclusion criteria:
- Female military healthcare beneficiaries with chronic pain syndrome (e.g. fibromyalgia) undergoing active narcotic-based treatment.
- Female military healthcare beneficiaries participating in other clinical trials the requirements of which may preclude complete involvement in this study.
- Female military healthcare beneficiaries with significant allergy to local anesthetics.
- Female military healthcare beneficiaries presenting with large (\>4cm), clinically node positive, painful, locally advanced breast cancer.
Exclusion
Key Trial Info
Start Date :
August 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00940199
Start Date
August 1 2006
End Date
June 1 2009
Last Update
July 15 2009
Active Locations (1)
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1
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States, 20307