Efficacy and Safety of Dignicap System for Preventing Chemotherapy Induced Alopecia

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chemotherapy Adjuvant, Breast Cancer

Intervention / Treatment
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* Device: Dignicap System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Dignicap System | Device: Dignicap System<br>* The DigniCap™ System consists of the digitized system for controlled scalp cooling (Digni C3) in conjunction with the soft, tight-fitting silicon cap (DigniCap™), the neoprene outer cap (DigniTherm™), and the liquid coolant (DigniCool). DIGNISTICK™ is prepared to log data from a treatment when inserted in the slot. DIGNICARD™ is a key card which has to be inserted in order to start a treatment.<br>* Other names: Cold cap;|
| No Intervention: Control Group<br>Concurrent age and chemotherapy matched control | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hair loss | 5 standardized photographs will be evaluated by the patient using the Dean Scale for alopecia | 4 weeks after last chemotherapy cycle | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability | The percentage of patients who complete all planned cycles of chemotherapy do so using the DigniCap™ System | Every 2 to 4 weeks for up to 12 weeeks | 
| Adverse events | spontaneous reporting by the patient or identified during physical examination | 6 months | 
| Hair regrowth | Patient assessment using hair regrowth survey | 4 Weeks after last chemotherapy | 
| Quality of Life | European Organization for Research and Treatment of Cancer-Quality of Life-BR23 questionnaire | 4 Weeks after last chemotherapy cycle | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cold cap, Scalp cooling, Chemotherapy induced alopecia, Breast cancer