Efficacy and Safety of Dignicap System for Preventing Chemotherapy Induced Alopecia

• ClinicalTrials.gov Identifier: NCT01831024
• Recruitment Status: Unknown
• First Posted: April 15, 2013
• Last Update Posted: October 19, 2016
• Sponsor: Target Health Inc.
• Information provided by (Responsible Party): Target Health Inc.

Tracking Information

• First Submitted Date: April 3, 2013
• First Posted Date: April 15, 2013
• Last Update Posted Date: October 19, 2016
• Study Start Date: July 2013
• Estimated Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Not Provided

Current Secondary Outcome Measures (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: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

• Chemotherapy Adjuvant
• Breast Cancer

Intervention

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

• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: September 30, 2013): 110
• Original Enrollment: Not Provided
• Estimated Study Completion Date: December 2020
• Estimated Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01831024
• Other Study ID Numbers: DIG-001
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Target Health Inc.
• Study Sponsor: Target Health Inc.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Target Health Inc.
• Verification Date: October 2016