Breast CancerDIGNICAPNCT03712696
Efficacy and Safety of DIGNICAP™ System
A study testing DIGNICAP™ in people with Breast Cancer and Chemotherapy-induced Alopecia, run by European Institute of Oncology at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Chemotherapy-induced Alopecia
- What is being tested?
- DIGNICAP™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteItaly
- Study dates
- 18 Jul 2014to 20 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women > 18 years of age Performance status (ECOG) 0- 1
- Documented diagnosis of stage I or II breast cancer
- A planned course of chemotherapy in the adjuvant setting with curative intent including one of the following regimens:
- Doxorubicin 60 mg/m2 or Epirubicin 90 mg/m2 and cyclophosphamide 600 mg/m2 x 4 cycles IV every 3 weeks
- Docetaxel 75 mg/m2 and cyclophosphamide 600 mg/m2 x 4 cycles IV every 3 weeks
- Paclitaxel 80 mg/m2 weekly IV x at least 12 weeks with or without IV trastuzumab
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- Docetaxel 75-100 mg/m2 IV every 3 weeks x 4 cycles with or without trastuzumab IV weekly or every 3 weeks
- Targeted agents such as trastuzumab are allowed
- Patients receiving a regimen including both an anthracycline and a taxane (at doses reported above) are also eligible for this trial (AC/T, EC/T, TAC, etc.)
- Plan to complete chemotherapy within 6 months
- 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
- Negative pregnancy test (in fertile women).
Who cannot join
- Patients with female pattern baldness resembling picture I-3 or higher on the Savin scale
- Previous chemotherapy
- 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.
- Concurrent hormone therapy with chemotherapy except LHRH analogue. Hormone therapy should be used as indicated following completion of chemotherapy
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study on the Efficacy and Safety of DIGNICAP™ System for Preventing Chemotherapy Induced Alopecia
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).
Read more
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.
Read the detailed description
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.
- Conditions
- Breast Cancer, Chemotherapy-induced Alopecia
- Being tested
- DIGNICAP™
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIGNICAP™Device
Scalp cooling to prevent chemotherapy-induced alopecia
| Study group | Role | What they receive |
|---|---|---|
| DIGNICAP™ | Experimental | DigniCap® System Receives: Device: DIGNICAP™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of hair loss
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)
Measured: 21 days
Secondary outcomes (6)
Hair loss assessed by physician
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)
Measured: 21 days
Assessment of head/scalp pain
Assessment of head/scalp pain using a Visual Analogue Scale (VAS) from 0 (not tolerable) to 100 (really well tolerable)
Measured: 21 days
Assessment of feeling chilled
Assessment of feeling chilled using a Visual Analogue Scale (VAS) from 0 (not at all chilled) to 10 (as bad as it could be)
Measured: 21 days
Assessment of patient satisfaction
Assessment of patient satisfaction using Technology Acceptance Model Questionnaire
Measured: 21 days
Assessment of patient symptoms
Assessment of patient symptoms using EORTC QLQ BR-23 Questionnaire
Measured: 21 days
Assessment of patient health status
Assessment of patient health status using EORTC QLQ C-30 Questionnaire
Measured: 21 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start18 Jul 2014
- Primary completion30 Apr 2018
- Study completion20 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open Label
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabetta Munzone, MD, Principal investigator, IEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712696
- Sponsor's protocol ID
- IEO 0075/
- Acronym
- DIGNICAP
- Status last verified
- Oct 2018
- First submitted
- 25 Sep 2018
- Last updated
- 19 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Munzone E, Bagnardi V, Campenni G, Mazzocco K, Pagan E, Tramacere A, Masiero M, Iorfida M, Mazza M, Montagna E, Cancello G, Bianco N, Palazzo A, Cardillo A, Dellapasqua S, Sangalli C, Pettini G, Pravettoni G, Colleoni M, Veronesi P. Preventing chemotherapy-induced alopecia: a prospective clinical trial on the efficacy and safety of a scalp-cooling system in early breast cancer patients treated with anthracyclines. Br J Cancer. 2019 Aug;121(4):325-331. doi: 10.1038/s41416-019-0520-8. Epub 2019 Jul 15.
PubMed 31303642
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Efficacy and Safety of DIGNICAP™ System for Preventing Chemotherapy Induced Alopecia
- ClinicalTrials.gov ID
- NCT03712696
- Acronym / sponsor ID
- DIGNICAP / IEO 0075/
- Conditions
- Breast Cancer, Chemotherapy-induced Alopecia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 18 Jul 2014 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 20 Sep 2018 (actual)
- First posted
- 19 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open Label
| Arm | Type | Receives |
|---|---|---|
| DIGNICAP™ | Experimental | Device: DIGNICAP™DigniCap® System |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Women > 18 years of age Performance status (ECOG) 0- 1
- Documented diagnosis of stage I or II breast cancer
- A planned course of chemotherapy in the adjuvant setting with curative intent including one of the following regimens:
- Plan to complete chemotherapy within 6 months
- Willing and able to sign informed consent for protocol treatment
Key exclusion criteria (14 listed)
- Patients with female pattern baldness resembling picture I-3 or higher on the Savin scale
- Previous chemotherapy
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DIGNICAP™Scalp cooling to prevent chemotherapy-induced alopecia | Device | DIGNICAP™ |
Primary outcome
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)
6 secondary outcomes
Hair loss assessed by physician
Time frame: 21 days
Assessment of head/scalp pain
Time frame: 21 days
Assessment of feeling chilled
Time frame: 21 days
Assessment of patient satisfaction
Time frame: 21 days
Assessment of patient symptoms
Time frame: 21 days
Assessment of patient health status
Time frame: 21 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2018.
- Derived from this study: PubMed 31303642Munzone E, Bagnardi V, Campenni G, Mazzocco K, Pagan E, Tramacere A, Masiero M, Iorfida M, Mazza M, Montagna E, Cancello G, Bianco N, Palazzo A, Cardillo A, Dellapasqua S, Sangalli C, Pettini G, Pravettoni G, Colleoni M, Veronesi P. Preventing chemotherapy-induced alopecia: a prospective clinical trial on the efficacy and safety of a scalp-cooling system in early breast cancer patients treated with anthracyclines. Br J Cancer. 2019 Aug;121(4):325-331. doi: 10.1038/s41416-019-0520-8. Epub 2019 Jul 15.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabetta Munzone, MD principal investigator
IEO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DIGNICAP™ in people with Breast Cancer and Chemotherapy-induced Alopecia, run by European Institute of Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of hair loss (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03712696, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2018.