Trial registered on ANZCTR


Trial ID
ACTRN12615001106527
Ethics application status
Approved
Date submitted
15/09/2015
Date registered
21/10/2015
Date last updated
21/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Chemotherapy-induced alopecia (CIA) in breast cancer patients: effectiveness of two temperature levels of scalp cooling on reducing rates of CIA.
Scientific title
Incidence of chemotherapy-induced alopecia (CIA) in breast cancer patients": effectiveness of two temperature levels of scalp cooling on reducing incidence of CIA
Secondary ID [1] 287475 0
BCRC113
Universal Trial Number (UTN)
Trial acronym
CIA-study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chemotherapy-induced alopecia 296217 0
breast cancer 296288 0
Condition category
Condition code
Cancer 296490 296490 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
scalp-cooling treatment:patient wears a cap which is connected to a refrigerated cooling system which pumps liquid coolant through the cap to keep the scalp cool and blood vessels constricted to minimise chemotherapy delivery to hair follicles. The TGA-approved cap will be fitted to patients on day 1 of each chemotherapy cycle at one of two temperature settings (3 degrees vs 5 degrees Celsius) 30 min prior, during and 90min after their chemotherapy treatment for the duration of their planned chemotherapy. Scalp cooling start/stop time, chemotherapy start/stop time as well as duration of scalp cooling interruption, if applicable, will be recorded.
Intervention code [1] 292858 0
Treatment: Devices
Comparator / control treatment
Historical data (viz published adjuvant chemotherapy trials evaluating contemporary chemotherapy regimens from early 2000 to current)
Control group
Historical

Outcomes
Primary outcome [1] 296116 0
incidence of patient reported minimal CIA (Dean's score 1/2 OR WHO grade 1/2) after completion of planned chemotherapy in this clinical setting compared to the population overall
Timepoint [1] 296116 0
End of chemotherapy
Secondary outcome [1] 317544 0
comparison of rate of minimal CIA ( patient-reported on Dean's scale for Hair loss and WHO Scale for Hair Loss) at the 2 temperature settings as per protocol
Timepoint [1] 317544 0
End of chemotherapy
Secondary outcome [2] 317545 0
Rate of compliance with scalp cooling as determined in the protocol: patient's adherence to scalp cooling duration at each cycle, and patient's adherence to scalp cooling temperature setting. Temperature settings and scalp cooling times as well as chemotherapy treatment times will be collected.
Timepoint [2] 317545 0
per cycle and overall for planned number of chemotherapy cycles
Secondary outcome [3] 317546 0
Composite outcome: frequency and severity of scalp-cooling adverse events. Known reported side-effects are feeling of cold, headache and light-headedness. At each treatment, the patient will be asked for any AEs/SAEs by study site staff who will document and report those AEs in the CRF and grade them according to CTCAE.
Timepoint [3] 317546 0
throughout study, at the start of each scalp cooling treatment
Secondary outcome [4] 317547 0
incidence of scalp metastasis as reported by patients (phone contact) or from review of medical records (routine standard of care visit)
Timepoint [4] 317547 0
yearly for 10 years since start of chemotherapy

Eligibility
Key inclusion criteria
- histologically confirmed invasive breast cancer
- suitable to receive one of the approved chemotherapy regiments, defined in the protocol, in the neo/adjuvant or metastatic setting
- minimum understanding of English language to complete quality of life questionnaire
- willingness to be followed for 10 years
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- history of malignant primary brain tumour
- history of scalp or brain metastasis
- recommended chemotherapy given on weekly schedule
- patient suffering from cold sensitivity, cold agglutinin disease, cryoglobulinemia, cryofibrogenemia or cold traumatic dystrophy
- prior chemotherapy for any reason
- allergy to silicon
- concurrent treatment affecting hair growth

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Within each treatment cohort, eligible patients will be randomised to one of two scalp cooling treatment arms on a 1:1 ratio.
Randomisation will be allocated by selected staff who do not have direct patient contact during the study. Allocation is concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Patients will be stratified according to treatment regimen recommended. There will be 3 treatment cohorts and within each cohort eligible patients will be randomised to one of two scalp cooling treatment arms on a 1:1 ratio.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
To detect a difference with 80% of power at a one-sided significant level of 0.025 (ower from 0.05 as Bonferroni correction applied to enable multiple groups comparisons), stratifying for treatment cohorts, a sample of 20 per cohort is required (assuming 20% dropout rate)

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Current
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 4349 0
Breast Cancer Research Centre - Western Australia - Perth
Recruitment postcode(s) [1] 10575 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 292053 0
Charities/Societies/Foundations
Name [1] 292053 0
Breast Cancer Research Centre - WA
Address [1] 292053 0
Hollywood Private Hospital
Entrance 3, Lower ground level
101 Monash Avenue
Nedlands WA 6009
Country [1] 292053 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Breast Cancer Research Centre of Western Australia
Address
Hollywood Private Hospital
Entrance 3, Lower ground level
101 Monash Avenue
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 290726 0
None
Name [1] 290726 0
Address [1] 290726 0
Country [1] 290726 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293535 0
Bellberry
Ethics committee address [1] 293535 0
Ethics committee country [1] 293535 0
Australia
Date submitted for ethics approval [1] 293535 0
14/10/2015
Approval date [1] 293535 0
30/11/2015
Ethics approval number [1] 293535 0

Summary
Brief summary
The primary purpose of this study is to gather more scientific data on the efficacy of scalp cooling to prevent chemotherapy-induced hair loss and to assess the effect of specific temperature used on the efficacy of scalp cooling. Who is it for? You may be eligible to join this study if you are 18 or over and have histologically confirmed invasive breast cancer, and a planned course of one of the approved chemotherapy regimens. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive scalp-cooling at 3 degrees Celsius or 5 degrees Celsius. Scalp-cooling involves wearing a cap connected to a cooling device that will lower the temperature of your scalp. The cap is to be worn at each chemotherapy treatment 30 minutes before, during and 90 minutes after the chemotherapy treatment. Patient outcomes will then be assessed through patient-reported level of hair loss at the end of planned chemotherapy and monitoring of short-term and long-term side effects of scalp-cooling for 10 years after the end of planned chemotherapy. It is hoped that the findings of this trial will enhance our knowledge of the efficacy and long-term safety of using scalp-cooling to prevent chemotherapy-induced alopecia in breast cancer patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60350 0
Prof Arlene Chan
Address 60350 0
Breast Cancer Research Centre-WA
Hollywood Private Hospital
Entrance 3, Lower Ground Floor
101 Monash Avenue
Nedlands WA 6009
Country 60350 0
Australia
Phone 60350 0
+ 61 8 9481 4522
Fax 60350 0
Email 60350 0
admin.profachan@me.com
Contact person for public queries
Name 60351 0
Mrs Jeannette Devoto
Address 60351 0
Breast Cancer Research Centre-WA
Hollywood Private Hospital
Entrance 3, Lower Ground Floor
101 Monash Avenue
Nedlands WA 6009
Country 60351 0
Australia
Phone 60351 0
+61 8 6500 5556
Fax 60351 0
Email 60351 0
BCTU@bcrc-wa.com.au
Contact person for scientific queries
Name 60352 0
Mrs Jeannette Devoto
Address 60352 0
Breast Cancer Research Centre-WA
Hollywood Private Hospital
Entrance 3, Lower Ground Floor
101 Monash Avenue
Nedlands WA 6009
Country 60352 0
Australia
Phone 60352 0
+61 8 6500 5556
Fax 60352 0
Email 60352 0
BCTU@bcrc-wa.com.au