Breast CancerPassionPNCT00940199
PASSION - P Trial: Ph Adjusted Sulfur-Colloid, Sentinel Initiative ON Pain Trial
An observational study of Breast Cancer, run by Walter Reed Army Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- Type of treatment
- Injection or infusion
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Jun 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307
About this study
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
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)
Read more
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.
Read the 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
- Keywords
- Breast cancer, sentinel lymph node mapping, biopsy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: June 2009
Secondary outcomes (1)
To assess objectively physician appraisal of patient pain during the radiocolloid injection and compare physician interpreted pain score with patient reported pain score
Measured: June 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2009 (estimated)
- Study startAug 2006
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Medical Center
- Sponsor type
- US federal agency
- Investigators
- Alexander Stojadinovic, M.D., Principal investigator, Walter Reed Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00940199
- Sponsor's protocol ID
- WU#06-20027
- Other IDs
- WU#06-20027
- Acronym
- PassionP
- Status last verified
- Jul 2009
- First submitted
- 14 Jul 2009
- Last updated
- 15 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19664956
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00940199
- Acronym / sponsor ID
- PassionP / WU#06-20027
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, sentinel lymph node mapping, biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Walter Reed Army Medical CenterUS federal agency
- Study start
- Aug 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 15 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2009.
- Derived from this study: PubMed 19664956Stojadinovic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Stojadinovic, M.D. principal investigator
Walter Reed Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Walter Reed Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. (time frame: June 2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00940199, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2009.