Details

Details

Title Scalp Cooling Alopecia Prevention Trial (SCALP)

IRB BYLR1114

CC 14-770

Hospital Main Campus

Disease Breast

Description

Description

Primary Objective

Demonstrate 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
  1. The Orbis Paxman Hair Loss Prevention System will significantly reduce chemotherapy-induced alopecia in woman with breast cancer undergoing neoadjuvant or adjuvant chemotherapy;
  2. 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;
  3. 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;
  4. 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

Inclusion Criteria

  1. New diagnosis of breast cancer stage I-II
  2. Planning to undergo neoadjuvant or adjuvant chemotherapy with curative intent
  3. 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.
  4. Subjects must have TSH collected within 1 year prior to treatment and found within acceptable limits as defined under exclusion criteria.
  5. 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)
  6. 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

Exclusion Criteria

  1. Stage 3 or 4 breast cancer or any other concurrent malignancy including hematological malignancies (i.e. leukemia or lymphoma)
  2. Baseline alopecia (defined CTCAE v4.0 grade > 0, see appendix B for CTCAE v4.0 scale)
  3. Subjects with cold agglutinin disease or cold urticaria
  4. Subjects who are scheduled for bone marrow ablation chemotherapy
  5. Subjects receiving chemotherapy with concurrent anthracycline and taxane (AT or TAC)
  6. Male gender
  7. Age ≥ 70 years
  8. 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.
  9. Elevated liver enzymes or bilirubin defined as 3 times the upper limits of normal
  10. Serum Albumin <3.0
  11. Subjects with anemia (defined as a hemoglobin <10)
  12. 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
  13. Subjects who have diabetes with a Hgb A1c >7
  14. Subjects who have lichen planus or lupus
  15. Subjects who are underweight (defined as a BMI <17.5)
  16. Subjects who have had previous chemotherapy exposure