PASSION - P Trial: Ph Adjusted Sulfur-Colloid, Sentinel Initiative ON Pain Trial - Full Text View

Sponsor:	Walter Reed Army Medical Center
Information provided by:	Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:	NCT00940199

Purpose

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 topical anesthetic cream 4% to the breast within one hour of sub-areaolar injection of 4 ml 99mTc-sulfur colloid (1 mCi in normal saline)

II. Sub-areolar injection of 4 ml pH-adjusted 99mTc-sulfur colloid (1 mCi in sodium bicarbonate)

III. Sub-areolar injection of 4 ml pH-adjusted 99mTc-sulfur colloid (1 mCi in 1% Lidocaine)

IV. Sub-areolar injection of 4 ml pH-adjusted 99mTc-sulfur colloid (1 mCi in sodium bicarbonate + 1% Lidocaine)

The primary study outcome is pain, which will be evaluated for each study group before, and after radiocolloid injection utilizing a standardized 10-point Likert scale, the Wong-Baker FACES Pain Rating Scale, and the McGill Pain Questionnaire. Physician appraisal of patient pain (Wong-Baker FACES Pain Rating Scale) will be estimated during the radiocolloid injection and compared with that of the patient.

Condition
Breast Cancer

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Lidocaine Sodium bicarbonate

U.S. FDA Resources

Further study details as provided by Walter Reed Army Medical Center:

Primary Outcome Measures:

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. [ Time Frame: June 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess objectively physician appraisal of patient pain during the radiocolloid injection and compare physician interpreted pain score with patient reported pain score [ Time Frame: June 2009 ] [ Designated as safety issue: No ]

Enrollment:	140
Study Start Date:	August 2006
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
Standard of Care I:Application of L-M-X topical anesthetic cream 4% to the breast within one hour of sub-areaolar injection of 4 ml 99mTc-sulfur colloid (1 mCi in normal saline)
1 mCi in sodium bicarbonate II. Sub-areolar injection of 4 ml pH-adjusted 99mTc-sulfur colloid (1 mCi in sodium bicarbonate)
1 mCi in 1% Lidocaine III. Sub-areolar injection of 4 ml pH-adjusted 99mTc-sulfur colloid (1 mCi in 1% Lidocaine)
1 mCi in sodium bicarbonate + 1% Lidocaine IV. Sub-areolar injection of 4 ml pH-adjusted 99mTc-sulfur colloid (1 mCi in sodium bicarbonate + 1% Lidocaine)

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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

The study population will consist of female military health care beneficiaries over the age of 18 years presenting with the diagnosis of breast cancer who meet inclusion criteria.

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00940199

Locations

United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307

Sponsors and Collaborators

Walter Reed Army Medical Center

Investigators

Principal Investigator:

Alexander Stojadinovic, M.D.

Walter Reed Army Medical Center

More Information

No publications provided by Walter Reed Army Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Stojadinovic A, Peoples GE, Jurgens JS, Howard RS, Schuyler B, Kwon KH, Henry LR, Shriver CD, Buckenmaier CC. Standard versus pH-adjusted and lidocaine supplemented radiocolloid for patients undergoing sentinel-lymph-node mapping and biopsy for early breast cancer (PASSION-P trial): a double-blind, randomised controlled trial. Lancet Oncol. 2009 Sep;10(9):849-54. Epub 2009 Aug 5.

Responsible Party:	COL Alexander Stojadinovic, Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:	NCT00940199 History of Changes
Other Study ID Numbers:	WU#06-20027, WU#06-20027
Study First Received:	July 14, 2009
Last Updated:	July 14, 2009
Health Authority:	United States: Federal Government

Keywords provided by Walter Reed Army Medical Center:

Breast cancer, sentinel lymph node mapping, biopsy

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants

Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012