Efficacy and Safety of Dignicap System for Preventing Chemotherapy Induced Alopecia



Status:Completed
Conditions:Breast Cancer, Cancer, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery, Oncology
Healthy:No
Age Range:18 - Any
Updated:5/5/2014
Start Date:July 2013
End Date:September 2014
Contact:Glen Park, PharmD
Email:gpark@targethealth.com
Phone:212-681-2100

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Clinical Performance, Efficacy and Safety of the DigniCap™ System, a Scalp Hypothermia System, in Preventing Chemotherapy Induced Alopecia in Patients With Early Stage Breast Cancer

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.


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
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New York, New York 10065
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1600 Divisadero Street
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