Details
Description
Inclusion Criteria
Exclusion Criteria
Details
Title Scalp Cooling Alopecia Prevention Trial (SCALP)
IRB BYLR 1114
CC 14-770
Hospital Main Campus
Disease Breast
Description
Primary ObjectiveDemonstrate 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.
Secondary Objectives- The Orbis Paxman Hair Loss Prevention System will significantly reduce chemotherapy-induced alopecia in woman with breast cancer undergoing neoadjuvant or adjuvant chemotherapy;
- Women who do not have clinically significant alopecia will have a better quality of life compared to those with alopecia and that the reduction of alopecia in breast cancer patients undergoing chemotherapy is associated with a lower risk of depression;
- Scalp cooling using the Orbis Paxman Hair Loss Prevention System is not associated with any unanticipated, clinically significant short-term safety effects, and the scalp cooling procedure is well-tolerated by patients undergoing chemotherapy;
- Scalp cooling using the Orbis Paxman Hair Loss Prevention System does not present an increased risk of scalp metastases for patients newly diagnosed with stage I - II breast cancer
Inclusion Criteria
- New diagnosis of breast cancer stage I-II
- 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 60 mg/m2 with cyclophosphamide 600 mg/m2
- Epirubicin 90-100 mg/m2 with cyclophosphamide 600 mg/m2
- Doxorubicin 50 mg/m2 with 5-Fluroruacil 500 mg/m2 and cyclophosphamide 500 mg/m2
- Paclitaxel 80-90 mg/m2 weekly (every 3 weeks constitutes a cycle), or 175 mg/m2 every 2-3 weeks as a single agent
- Paclitaxel 80-90 mg/m2 weekly with carboplatin AUC of 6 every 3 weeks
- Docetaxel 100 mg/m2 as a single agent
- Docetaxel 75-100 mg/m2 with pertuzumab and trastuzumab at standard doses
- Docetaxel 75 mg/m2 with cyclophosphamide 600 mg/m2
- Docetaxel 75 mg/m2 with carboplatin AUC of 6 and trastuzumab at standard doses
- Concurrent trastuzumab 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.
- Defined as one of the following regimens:
- Subjects must have TSH collected within 1 year prior to treatment and found within acceptable limits as defined under exclusion criteria.
- If subject has a history of diabetes, hemoglobin A1c must be drawn within 3 months prior to treatment and found to be within acceptable limits (defined under exclusion criteria)
- CBC and CMP should be done within 4 weeks prior to treatment and found to be within acceptable limits (defined under exclusion criteria)
Exclusion Criteria
- 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
- Personal history of migraines,cluster or tension headaches as defined as actual medical diagnosis by a physician and/ or prescribed medications. If personal history of migraines was related to a past medical problem that is now resolved, subject may go on study at the discretion of the Principal Investigator.
- Elevated liver enzymes or bilirubin defined as 3 times the upper limits of normal
- Serum Albumin <3.0
- Subjects with anemia (defined as a hemoglobin <10)
- Abnormal TSH, AND:
- If high, abnormal free T4 defined as out of normal limits
- If low, abnormal free T4 or T3 defined as out of normal limits
- Subjects who have diabetes with a Hgb A1c >7
- Subjects who have lichen planus or lupus
- Subjects who are underweight (defined as a BMI <17.5)
- Subjects who have had previous chemotherapy exposure