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Prospective Randomized Trial of Standard Versus pH-adjusted Radiocolloid for Patients Undergoing Sentinel Lymph Node Mapping and Biopsy for Breast Cancer PASSION - P Trial: Ph Adjusted Sulfur-Colloid, Sentinel Initiative ON Pain Trial


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

Prospective Randomized Trial of Standard Versus pH-adjusted Radiocolloid for Patients Undergoing Sentinel Lymph Node Mapping and Biopsy for Breast Cancer PASSION - P Trial: Ph Adjusted Sulfur-Colloid, Sentinel Initiative ON Pain Trial


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.

Objectives and scientific aims:

To compare the intensity of pain (Wong-Baker FACES Pain Rating Scale + McGill Pain
Questionnaire) associated with WRAMC's current standard and pH-adjusted radiocolloid for
patients undergoing sentinel lymph node mapping and biopsy for breast cancer.

To assess objectively physician appraisal of patient pain during the radiocolloid injection
and compare physician interpreted pain score with patient reported pain score.

Define the success rate of intra-operative SLN identification for each study group.

Inclusion Criteria


Inclusion criteria:

1. 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.

2. Written informed consent must be obtained from each patient prior to entering the
study.

3. Female military healthcare beneficiaries with early breast cancer scheduled to
undergo sentinel lymph node mapping and biopsy at WRAMC

Exclusion criteria:

1. Female military healthcare beneficiaries with chronic pain syndrome (e.g.
fibromyalgia) undergoing active narcotic-based treatment.

2. Female military healthcare beneficiaries participating in other clinical trials the
requirements of which may preclude complete involvement in this study.

3. Female military healthcare beneficiaries with significant allergy to local
anesthetics.

4. Female military healthcare beneficiaries presenting with large (>4cm), clinically
node positive, painful, locally advanced breast cancer.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

To compare the intensity of pain (Wong-Baker FACES Pain Rating Scale + McGill Pain Questionnaire) associated with WRAMC's current standard and pH-adjusted radiocolloid for patients undergoing sentinel lymph node mapping and biopsy for breast cancer.

Outcome Time Frame:

June 2009

Safety Issue:

No

Principal Investigator

Alexander Stojadinovic, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Walter Reed Army Medical Center

Authority:

United States: Federal Government

Study ID:

WU#06-20027

NCT ID:

NCT00940199

Start Date:

August 2006

Completion Date:

June 2009

Related Keywords:

  • Breast Cancer
  • Breast cancer, sentinel lymph node mapping, biopsy
  • Breast Neoplasms

Name

Location

Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000