Efficacy and Safety of Dignicap System for Preventing Chemotherapy Induced Alopecia

Target Health

Status

Unknown

Conditions

Breast Cancer

Chemotherapy Adjuvant

Treatments

Device: Dignicap System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01831024

DIG-001

Details and patient eligibility

About

The efficacy and safety of the Dignicap System to prevent chemotherapy induced alopecia will be evaluated in women with early breast cancer undergoing adjuvant or neoadjuvant chemotherapy regimens. The scalp cold cap will be applied at each chemotherapy cycle. Hair loss will be evaluated by patient self assessment of 5 standardized photographs taken prior to each chemotherapy cycle. A concurrent control group not using a cold cap will also be evaluated.

Enrollment

110 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Female patients >/= 18 years of age
Documented diagnosis of stage I or II breast cancer
A planned course of chemotherapy in the adjuvant or neoadjuvant setting with curative intent including one of the following regimens:
- Doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 x 4 - 6 cycles IV every 2 - 3 weeks
- Docetaxel 75 mg/m2 and cyclophosphamide 600 mg/m2 x 4 - 6 cycles IV every 3 weeks
- Paclitaxel 80 mg/m2 weekly IV x at least 12 weeks with or without IV trastuzumab
- Paclitaxel 175 mg/m2 IV every 2 weeks x 4 - 6 cycles (without an anthracycline)
- Paclitaxel weekly and carboplatin AUC 2 weekly or AUC 6 every 3 weeks IV x 4 - 6 cycles and trastuzumab IV weekly or every 3 weeks
- Docetaxel 75 mg/m2 and carboplatin AUC 6 IV every 3 weeks x 4 - 6 cycles and trastuzumab IV weekly or every 3 weeks
- Targeted agents such as trastuzumab or lapatinib are allowed
Plan to complete chemotherapy within 6 months
At least two years out from the last chemotherapy causing hair loss with complete recovery of hair
Karnofsky performance status >/= 80%
Willing and able to sign informed consent for protocol treatment
Willing to participate in study procedures including having photographs of the head before the first cycle of chemotherapy and 1 month after the last chemotherapy
Willing to enroll in an extension protocol for follow up for 5 years following the end of chemotherapy treatment

Exclusion criteria

Patients with female pattern baldness resembling picture I-3 or higher on the Savin scale
Autoimmune disease affecting hair; e.g. alopecia areata, systemic lupus with associated hair loss
A history of whole brain radiation
Plans to use a chemotherapy regimen other than those specified in the inclusion criteria. Specifically, patients receiving a regimen including both an anthracycline and a taxane are not eligible for this trial (AC/T, EC/T, TAC, etc.)
Concurrent hormone therapy with chemotherapy. Hormone therapy should be used as indicated following completion of chemotherapy
Underlying clinically significant liver disease including active viral hepatitis with abnormal liver function tests >1.5 times the upper limit of normal, including alkaline phosphatase, AST, and total bilirubin. Patients with Gilbert´s disease (elevated indirect bilirubin only) will be eligible for participation.
Clinically significant renal dysfunction defined as serum creatinine > upper limit of normal.
A serious concurrent infection or medical illness which would jeopardize the ability of the patient to complete the planned therapy and follow-up
A history of persistent grade 2 (or higher) alopecia induced by prior chemotherapeutic regimens
Participation in any other clinical investigation or exposure to other investigational agents, drugs, device or procedure that may cause hair loss
Intercurrent life-threatening malignancy
A history of cold agglutinin disease or cryoglobulinemia.
Evidence of untreated or poorly controlled hyper or hypothyroidism
A history of silicon allergy
American Society of Anesthesiologist Class ≥3