Scalp Cooling to Prevent Chemo-induced Hair Loss

Status unconfirmed · Not applicable

Conditions studied: Breast Cancer, Alopecia

In brief

Determine that the Orbis Paxman Hair Loss Prevention System is safe and effective in reducing chemotherapy-induced alopecia in woman with breast cancer undergoing neoadjuvant or adjuvant chemotherapy.

Key facts

Study ID

NCT01986140

Run by

Julie Nangia

People needed

236

Starts

2014-05-15

Expected to finish

2022-12-01

Last updated by the study team

2021-07-27

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• New diagnosis of breast cancer stage 1-2
• 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.

You may not qualify if…

• Stage 3 or 4 breast cancer or any other concurrent malignancy including hematological malignancies (i.e. leukemia or lymphoma)
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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