Health Condition 1: null- Breast Cancer
Conditions
Interventions
Intervention1: Paxman Scalp Cooling System: It will enable us (and the community) to know whether or not scalp cooling is helpful in decreasing chemotherapy induced hair loss
Sponsors
Access Devices
Eligibility
Inclusion criteria
Inclusion criteria: • New diagnosis of non-metastatic breast cancer • 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: ï?? EC (Epirubicin 90mg/m2) & (Cyclophosphamide 600 mg/m2) or FEC (5Florouracil 500 mg/m2, Epirubicin 90mg/m2 & Cyclophosphamide 500 mg/m2 x 4 cycles ï?? Followed by weekly Paclitaxel (80mg/m2) x 12 weeks or 3 weekly Paclitaxel (175 mg/m2) or Docetaxel (100 mg/m2) x 4 cycles •Concurrent trastuzumab at standard doses is allowed. •Administration of chemotherapy on a dose dense schedule is allowed as clinically indicated.
Exclusion criteria
Exclusion criteria: •Metastatic breast cancer •Baseline alopecia (defined CTCAE v4.0 grade > 0, see Appendix B) •Subjects with cold agglutinin disease or cold urticaria. •Subjects receiving chemotherapy with concurrent anthracycline and taxane (AT or TAC) •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. •Subjects who have lichen, planus or lupus. •Subjects who have had previous chemotherapy exposure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare success in hair preservation, between the Paxman Scalp Cooling System and control (no cooling)Timepoint: Post 4 cycles of anthracycline and/or taxane based chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| To estimate the rate of significant anticipated device effects like headache, complaints of coldness, heaviness in the head and neck pain (especially after removal of cooling cap). 2. To compare QOL scores (by EORTC QLQ BR23 module) between the Paxman Scalp Cooling System and control (no cooling) after 4 cycles of chemotherapy Timepoint: To estimate the rate of significant anticipated device effects like headache, complaints of coldness, heaviness in the head and neck pain (especially after removal of cooling cap). 2. To compare QOL scores (by EORTC QLQ BR23 module) between the Paxman Scalp Cooling System and control (no cooling) after 4 cycles of chemotherapy | — |
Countries
India
Contacts
Public ContactYogesh Kembhavi
Professor, Medical Oncology
Outcome results
None listed