ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12615001106527

Ethics application status

Approved

Date submitted

15/09/2015

Date registered

21/10/2015

Date last updated

8/04/2021

Date data sharing statement initially provided

11/01/2019

Date results provided

11/01/2019

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]

BCRC113

Universal Trial Number (UTN)

Trial acronym

CIA-study

Linked study record

Health condition

Health condition(s) or problem(s) studied:

chemotherapy-induced alopecia

breast cancer

Condition category

Condition code

Cancer

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]

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]

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]

End of chemotherapy

Secondary outcome [1]

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]

End of chemotherapy

Secondary outcome [2]

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]

per cycle and overall for planned number of chemotherapy cycles

Secondary outcome [3]

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]

throughout study, at the start of each scalp cooling treatment

Secondary outcome [4]

incidence of scalp metastasis as reported by patients (phone contact) or from review of medical records (routine standard of care visit)

Timepoint [4]

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

Sex

Females

Can healthy volunteers participate?

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

23/12/2015

Actual

30/12/2015

Date of last participant enrolment

Anticipated

Actual

10/02/2017

Date of last data collection

Anticipated

13/11/2025

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Breast Cancer Research Centre - Western Australia - Perth

Recruitment postcode(s) [1]

6000 - Perth

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Breast Cancer Research Centre - WA

Address [1]

Hollywood Consulting Centre
Suite 407, 4th floor
91 Monash Avenue
Nedlands WA 6009

Country [1]

Australia

Primary sponsor type

Charities/Societies/Foundations

Name

Breast Cancer Research Centre of Western Australia

Address

Hollywood Consulting Centre
Suite 407, 4th floor
91 Monash Avenue
Nedlands WA 6009

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bellberry

Ethics committee address [1]

123 Glen Osmond Road
Eastwood SA 5063
+61 8 8361 3222

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/10/2015

Approval date [1]

30/11/2015

Ethics approval number [1]

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

Prof Arlene Chan

Address

Breast Cancer Research Centre,-WA, Suite 407, Hollywood Consulting Centre, 91 Monash Avenue, Nedlands, 6009 WA

Country

Australia

Phone

+ 61 8 9481 4522

Fax

admin.profachan@me.com

Contact person for public queries

Name

Jeannette Devoto

Address

Breast Cancer Research Centre,-WA, Suite 407, Hollywood Consulting Centre, 91 Monash Avenue, Nedlands, 6009 WA

Country

Australia

Phone

+61 8 6500 5556

Fax

BCTU@bcrc-wa.com.au

Contact person for scientific queries

Name

Jeannette Devoto

Address

Breast Cancer Research Centre,-WA, Suite 407, Hollywood Consulting Centre, 91 Monash Avenue, Nedlands, 6009 WA

Country

Australia

Phone

+61 8 6500 5556

Fax

BCTU@bcrc-wa.com.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Data will only be shared amongst participating investigators as pertains to the study endpoints and specified analyses

When will data be available (start and end dates)?

At time of data clean and first data analysis and up until time of final publication

Available to whom?

Participating investigators

Available for what types of analyses?

Analyses as planned per protocol, or as exploratory analyses based on study's findings which may serve as rationale for further clinical research evaluation

How or where can data be obtained?

Data fields from primary study database will be shared as de-identified records in Excel spreadsheet.

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Efficacy of scalp cooling in reducing alopecia in early breast cancer patients receiving contemporary chemotherapy regimens.	2018	https://dx.doi.org/10.1016/j.breast.2018.07.006

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically