Study Results
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View full resultsBasic Information
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UNKNOWN
NA
236 participants
INTERVENTIONAL
2014-05-15
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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PAXMAN Orbis Scalp Cooler
Scalp Cooling
PAXMAN Orbis Scalp Cooler
Treatment with Orbis scalp cooling cap
Control No treatment
Control
Control No treatment
No treatment to prevent hair loss
Interventions
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PAXMAN Orbis Scalp Cooler
Treatment with Orbis scalp cooling cap
Control No treatment
No treatment to prevent hair loss
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Planning to undergo neoadjuvant or adjuvant chemotherapy with curative intent
* Chemotherapy must be planned for at least 4 cycles of full-dose anthracycline or taxane based chemotherapy regimen,
* Defined as one of the following regimens: - Adriamycin 60mg/m2 with cyclophosphamide 600mg/m2 - Epirubicin 90-100mg/m2 with cyclophosphamide 600mg/m2 - Doxorubicin 50mg/m2 with 5-Fluroruacil 500mg/m2 and Cyclophosphamide 500mg/m2 - Paclitaxel 80mg-90/m2 weekly (every three weeks constitute a cycle), or 175 mg/m2 every 2-3 weeks as a single agent - Docetaxel 100mg/m2 as a single agent - Docetaxel 75mg/m2-100mg/m2 with pertuzumab and traztuzumab at standard doses - Docetaxel 75mg/m2 with cyclophosphamide 600mg/m2 - Docetaxel 75mg/m2 with carboplatin AUC of 6 and trastuzumab at standard doses
* Concurrent traztuzumab at standard doses is allowed
* Concurrent pertuzumab at standard doses is allowed
* Administration of chemotherapy on a dose dense schedule is allowed as clinically indicated.
* Subjects must have TSH collected within 1 year prior to treatment and found within normal range.
* If patient has a history of diabetes, Hemoglobin A1c must be drawn within 3 months prior to treatment and found to be within normal limits.
* CBC and CMP should be done within 4 weeks prior to treatment and found to be within acceptable limits.
Exclusion Criteria
* Baseline alopecia (defined CTCAE v4.0 grade \> 0, see appendix B for CTCAE v4.0 scale)
* Subjects with cold agglutinin disease or cold urticaria
* Subjects who are scheduled for bone marrow ablation chemotherapy
* Subjects receiving chemotherapy with concurrent anthracycline and taxane (AT or TAC)
* Male gender
* Age \>= 70 years
18 Years
FEMALE
No
Sponsors
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Julie Nangia
OTHER
Responsible Party
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Julie Nangia
Assistant Professor
Principal Investigators
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Julie Nangia, M.D.
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Locations
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Hematology & Oncology Associates of Northern New Jersey
Morristown, New Jersey, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Texas Oncology - Medical City Dallas
Dallas, Texas, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
USOncology / Texas Oncology-Memorial City
Houston, Texas, United States
Lester and Sue Smith Breast Center at Baylor College of Medicine
Houston, Texas, United States
Countries
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References
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Chevli N, Wang K, Haque W, Schwartz MR, Nangia J, Sasaki J, Farach AM, Hatch SS, Butler EB, Teh BS. Prognostic Impact of Radiation Therapy in Pure Mucinous Breast Carcinoma. Clin Breast Cancer. 2022 Oct;22(7):e807-e817. doi: 10.1016/j.clbc.2022.06.005. Epub 2022 Jul 7.
Nangia J, Wang T, Osborne C, Niravath P, Otte K, Papish S, Holmes F, Abraham J, Lacouture M, Courtright J, Paxman R, Rude M, Hilsenbeck S, Osborne CK, Rimawi M. Effect of a Scalp Cooling Device on Alopecia in Women Undergoing Chemotherapy for Breast Cancer: The SCALP Randomized Clinical Trial. JAMA. 2017 Feb 14;317(6):596-605. doi: 10.1001/jama.2016.20939.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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H: 33692 SCALP
Identifier Type: -
Identifier Source: org_study_id
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