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

NCT ID: NCT00940199

Last Updated: 2009-07-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2009-06-30

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 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.

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

No interventions assigned to this group

1 mCi in sodium bicarbonate

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

No interventions assigned to this group

1 mCi in 1% Lidocaine

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

No interventions assigned to this group

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)

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Walter Reed Army Medical Center

FED

Sponsor Role: lead

Responsible Party

Walter Reed Army Medical Center

Principal Investigators

Alexander Stojadinovic, M.D.

Role: PRINCIPAL_INVESTIGATOR

Walter Reed Army Medical Center

Locations

Walter Reed Army Medical Center

Washington D.C., District of Columbia, United States

Countries

United States

References

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. doi: 10.1016/S1470-2045(09)70194-9. Epub 2009 Aug 5.

Reference Type: DERIVED

PMID: 19664956 (View on PubMed)

Other Identifiers

WU#06-20027

Identifier Type: -

Identifier Source: secondary_id

WU#06-20027

Identifier Type: -

Identifier Source: org_study_id