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Efficacy and Safety of Dignicap System for Preventing Chemotherapy Induced Alopecia

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ClinicalTrials.gov Identifier: NCT01831024
Recruitment Status : Unknown
Verified October 2016 by Target Health Inc..
Recruitment status was:  Active, not recruiting
First Posted : April 15, 2013
Last Update Posted : October 19, 2016
Sponsor:
Information provided by (Responsible Party):
Target Health Inc.

Tracking Information
First Submitted Date  ICMJE April 3, 2013
First Posted Date  ICMJE April 15, 2013
Last Update Posted Date October 19, 2016
Study Start Date  ICMJE July 2013
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2013)
Hair loss [ Time Frame: 4 weeks after last chemotherapy cycle ]
5 standardized photographs will be evaluated by the patient using the Dean Scale for alopecia
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2013)
  • Tolerability [ Time Frame: Every 2 to 4 weeks for up to 12 weeeks ]
    The percentage of patients who complete all planned cycles of chemotherapy do so using the DigniCap™ System
  • Adverse events [ Time Frame: 6 months ]
    spontaneous reporting by the patient or identified during physical examination
  • Hair regrowth [ Time Frame: 4 Weeks after last chemotherapy ]
    Patient assessment using hair regrowth survey
  • Quality of Life [ Time Frame: 4 Weeks after last chemotherapy cycle ]
    European Organization for Research and Treatment of Cancer-Quality of Life-BR23 questionnaire
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Dignicap System for Preventing Chemotherapy Induced Alopecia
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Chemotherapy Adjuvant
  • Breast Cancer
Intervention  ICMJE Device: Dignicap System
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.
Other Name: Cold cap
Study Arms  ICMJE
  • Experimental: Treatment Group
    Dignicap System
    Intervention: Device: Dignicap System
  • No Intervention: Control Group
    Concurrent age and chemotherapy matched control
Publications * Rugo HS, Klein P, Melin SA, Hurvitz SA, Melisko ME, Moore A, Park G, Mitchel J, Bågeman 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 30, 2013)
110
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01831024
Other Study ID Numbers  ICMJE DIG-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Target Health Inc.
Study Sponsor  ICMJE Target Health Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Target Health Inc.
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP