Clinical trial NCT01831024: Efficacy and Safety of Dignicap System for Preventing Chemotherapy Induced Alopecia
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chemotherapy Adjuvant
Breast Cancer
Keywords: Cold cap
Scalp cooling
Chemotherapy induced alopecia
Breast cancer
Lead sponsor: Target Health Inc.
Sponsor class: INDUSTRY
First posted: 2013-04-15
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Hair loss
timeFrame: 4 weeks after last chemotherapy cycle
Secondary outcomes:
measure: Tolerability
timeFrame: Every 2 to 4 weeks for up to 12 weeeks
measure: Adverse events
timeFrame: 6 months
measure: Hair regrowth
timeFrame: 4 Weeks after last chemotherapy
measure: Quality of Life
timeFrame: 4 Weeks after last chemotherapy cycle
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Helen Diller Family Comprehensive Cancer Center
state: California
city: New York
country: United States
facility: Beth Israel Medical Center, Comprehensive Cancer Center
state: New York
city: New York
country: United States
facility: Weill Cornell Breast Center
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
Study officials:
References:
citation: Rugo HS, Klein P, Melin SA, Hurvitz SA, Melisko ME, Moore A, Park G, Mitchel J, Bageman E, D'Agostino RB Jr, Ver Hoeve ES, Esserman L, Cigler T. Association Between Use of a Scalp Cooling Device and Alopecia After Chemotherapy for Breast Cancer. JAMA. 2017 Feb 14;317(6):606-614. doi: 10.1001/jama.2016.21038.