Efficacy and Safety of DIGNICAP™ System (DIGNICAP)
|ClinicalTrials.gov Identifier: NCT03712696|
Recruitment Status : Completed
First Posted : October 19, 2018
Last Update Posted : October 19, 2018
Chemotherapy-induced alopecia (CIA) is one of the most common and emotionally distressing side effects of cancer therapy.
In this study we sought to assess the feasibility and the effectiveness of scalp cooling system DigniCap® to prevent alopecia in primary breast cancer patients receiving an anthracycline containing adjuvant chemotherapy (CT).
A prospective two-stage design clinical trial conducted at a single Institution of women with primary breast cancer scheduled to receive anthracycline with or without taxane-based adjuvant CT. Patients were enrolled from July 2014 to November 2016, with ongoing annual follow up for 5 years.
The scalp cooling period initiated approximately 30 minutes before CT. Scalp temperature was to be maintained at 3-5°C throughout CT and for 90 to 120 minutes afterward, depending on the CT drug and dose.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Chemotherapy-induced Alopecia||Device: DIGNICAP™||Not Applicable|
Scalp cooling to prevent chemotherapy-induced alopecia has been in use since the 1970's and offers excellent or good prevention of alopecia caused by many chemotherapeutic regimens, including those commonly used for breast cancer. The protection from alopecia offered by scalp cooling is a consequence of vasoconstriction resulting in reduced blood flow in the scalp, and reduced metabolic rate in the hair follicles with consequent decreased exposure to the chemotherapeutic agents. This limits the damage to dividing cells in the hair follicles.
In general, scalp cooling is well tolerated. Tolerance can be graded by a Visual Analogue Scale of 0-10, in which 0 represents 'not tolerable' and 10 means 'really well tolerable'. Mean scores vary between 6.9 and 8.0. No serious side effects have been reported. The most common reported side effects are headaches, unpleasant feelings due to the heaviness of the cap and coldness, dizziness and transient lightheadedness. Headaches are mostly not severe and can usually be prevented by paracetamol. Freezing has never been reported. Side effects in more than 10% of the patients were the reason to stop scalp cooling in only four of all studies.
DigniCap® System has been developed to provide continuous scalp cooling with high efficacy, safety and acceptable patient comfort. The system consists of a refrigerator unit integrated into a control unit based on a computerized interface. The system forms a compact mobile cabinet to which a soft and tight-fitting silicon cap is connected via a tube. A liquid coolant is pumped from the cooled reservoir in the cabinet to circulate through small canals within the cap. Two separate cooling circuits allow coolant to flow through the front and the back of the cap autonomously. Scalp temperature is monitored by three separate sensors in the cap: two temperature sensors and a security sensor. Deviations from the preset temperatures are immediately detected and automatically adjusted by the system. An outer cap made of neoprene is used to secure and insulate the inner silicon cap.
Since hair loss becomes noticeably visible after the loss of 50% or more of the scalp hair, the efficacy and safety of the Dignicap System to prevent chemotherapy induced alopecia will be evaluated in women with early breast cancer undergoing adjuvant chemotherapy regimens. The scalp cold cap will be applied at each chemotherapy cycle. Hair loss will be evaluated by patient self assessment (VAS scale), and by means of 5 standardized photographs taken prior to each chemotherapy cycle and by physician by the 5 point Dean's scale.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||139 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open Label|
|Masking:||None (Open Label)|
|Official Title:||A Study on the Efficacy and Safety of DIGNICAP™ System for Preventing Chemotherapy Induced Alopecia|
|Actual Study Start Date :||July 18, 2014|
|Actual Primary Completion Date :||April 30, 2018|
|Actual Study Completion Date :||September 20, 2018|
Scalp cooling to prevent chemotherapy-induced alopecia
- Reduction of hair loss [ Time Frame: 21 days ]Hair loss (HR) assessed by the patient herself after completing the last cycle of chemotherapy (21 days after last CT infusion) using photographs taken 5 angles using a VAS (Visual Analogue Scale) (Grade 0: no hair loss; Grade 1: < 25% hair loss; Grade 2: 25-50% of hair loss; Grade 3: 50-75% of hair loss; Grade 4: >75% of hair loss)
- Hair loss assessed by physician [ Time Frame: 21 days ]Reduction of hair loss assessed by physician by the 5 point Dean's scale (Judith C Dean's Scale for hair loss) (Grade 0: no hair loss; Grade 1: < 25% hair loss; Grade 2: 25-50% of hair loss; Grade 3: 50-75% of hair loss; Grade 4: >75% of hair loss)
- Assessment of head/scalp pain [ Time Frame: 21 days ]Assessment of head/scalp pain using a Visual Analogue Scale (VAS) from 0 (not tolerable) to 100 (really well tolerable)
- Assessment of feeling chilled [ Time Frame: 21 days ]Assessment of feeling chilled using a Visual Analogue Scale (VAS) from 0 (not at all chilled) to 10 (as bad as it could be)
- Assessment of patient satisfaction [ Time Frame: 21 days ]Assessment of patient satisfaction using Technology Acceptance Model Questionnaire
- Assessment of patient symptoms [ Time Frame: 21 days ]Assessment of patient symptoms using EORTC QLQ BR-23 Questionnaire
- Assessment of patient health status [ Time Frame: 21 Days ]Assessment of patient health status using EORTC QLQ C-30 Questionnaire
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712696
|European Institute of Oncology|
|Principal Investigator:||Elisabetta Munzone, MD||IEO|