Efficacy and Safety of Dignicap System for Preventing Chemotherapy Induced Alopecia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Target Health Inc.
ClinicalTrials.gov Identifier:
NCT01831024
First received: April 3, 2013
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Chemotherapy Adjuvant
Breast Cancer
Device: Dignicap System

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Target Health Inc.:

Primary Outcome Measures:
  • Hair loss [ Time Frame: 4 weeks after last chemotherapy cycle ] [ Designated as safety issue: No ]
    5 standardized photographs will be evaluated by the patient using the Dean Scale for alopecia


Secondary Outcome Measures:
  • Tolerability [ Time Frame: Every 2 to 4 weeks for up to 12 weeeks ] [ Designated as safety issue: Yes ]
    The percentage of patients who complete all planned cycles of chemotherapy do so using the DigniCap™ System

  • Adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    spontaneous reporting by the patient or identified during physical examination

  • Hair regrowth [ Time Frame: 4 Weeks after last chemotherapy ] [ Designated as safety issue: No ]
    Patient assessment using hair regrowth survey

  • Quality of Life [ Time Frame: 4 Weeks after last chemotherapy cycle ] [ Designated as safety issue: No ]
    European Organization for Research and Treatment of Cancer-Quality of Life-BR23 questionnaire


Estimated Enrollment: 110
Study Start Date: July 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Group
Dignicap System
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
No Intervention: Control Group
Concurrent age and chemotherapy matched control

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01831024

Locations
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, New York
Weill Cornell Breast Center
New York, New York, United States, 10065
Beth Israel Medical Center, Comprehensive Cancer Center
New York, New York, United States, 10011
United States, North Carolina
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Target Health Inc.
  More Information

No publications provided

Responsible Party: Target Health Inc.
ClinicalTrials.gov Identifier: NCT01831024     History of Changes
Other Study ID Numbers: DIG-001
Study First Received: April 3, 2013
Last Updated: June 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Target Health Inc.:
Cold cap
Scalp cooling
Chemotherapy induced alopecia
Breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Alopecia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hypotrichosis
Hair Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 18, 2014