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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01831024
Other study ID # DIG-001
Secondary ID
Status Active, not recruiting
Phase N/A
First received April 3, 2013
Last updated October 18, 2016
Start date July 2013
Est. completion date December 2020

Study information

Verified date October 2016
Source Target Health Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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Study Design

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


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.

Locations

Country Name City State
United States Beth Israel Medical Center, Comprehensive Cancer Center New York New York
United States Weill Cornell Breast Center New York New York
United States UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California
United States Wake Forest University School of Medicine Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Target Health Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hair loss 5 standardized photographs will be evaluated by the patient using the Dean Scale for alopecia 4 weeks after last chemotherapy cycle No
Secondary 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 Yes
Secondary Adverse events spontaneous reporting by the patient or identified during physical examination 6 months Yes
Secondary Hair regrowth Patient assessment using hair regrowth survey 4 Weeks after last chemotherapy No
Secondary Quality of Life European Organization for Research and Treatment of Cancer-Quality of Life-BR23 questionnaire 4 Weeks after last chemotherapy cycle No
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