Breast Cancer FemaleNCT04117815
Hair-Safe Study: Scalp Cooling for Hair Saving in Women Undergoing Chemotherapy
An observational study of Breast Cancer Female and Alopecia, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
Chemotherapy (CT) is a frequent and well established treatment in women with breast and gynecological tumors. Alopecia is one of the most common side effects of CT seriously impairing patient quality of life and body image. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Breast Cancer Female, Alopecia
- What is being tested?
- Paxman Scalp Cooling System and Alopecia Assessments
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 128 participants
- Where
- 1 siteAustria
- Study dates
- 18 May 2018to 28 Feb 2021
- Phase
- Observational
- 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 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study is designed as a clinical trial for women with breast or gyneological cancer, planning to undergo taxane- or anthracyline-based CT in a routine clinical setting. For the purpose of comparison, a reference sample is included in the study.
Who may be able to join
- Patients with breast or gynecological cancer planning to undergo CT
- CT can be neoadjuvant, adjuvant or palliative
- Up to two lines of CT are allowed. Adjuvant therapy counts as one line
- CT regime is associated with alopecia
- CT must be planned for at least 4 cycles of taxane or anthracyline-based CT regimen
- written informed consent age 18 and older
Who cannot join
- Migraine
- Cold allergy/Cold Agglutinins/Morbus Raynaud
- Hematological malignancies (Leukemia, non Hodgkins and other generalized lymphomas)
- Manifest scalp metastases
- Overt cognitive impairment
- Insufficient knowledge of German language
Show all 16Show fewer
- Reference Population:
- Patients with breast or gynecological cancer planning to undergo CT
- CT can be adjuvant, neoadjuvant or palliative
- up to two lines of CT are allowed. Adjuvant therapy counts as one line.
- CT regime is associated with alopecia
- CT must be planned for at least 4 cycles of taxane or anthracycline-based CT regime
- Refuse to undergo scalp cooling
- Patients who have been excluded for the study group for the reason of migraine
- written informed consent
- age 18 and older
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University Innsbruck, Department of Gynaecology and Obstetrics
Innsbruck, Tyrol, 6020
About this study
Chemotherapy (CT) is a frequent and well established treatment in women with breast and gynecological tumors. Alopecia is one of the most common side effects of CT seriously impairing patient quality of life and body image. While other CT associated side effects can be controlled by supportive treatment strategy, adequate preventive measures for alopecia have been lacking. New evidence supports the efficacy of scalp cooling for alopecia prevention during CT.
Read the detailed description
Scalp cooling using cooling caps has been identified as an effective treatment option against CT-induced alopecia in numerous European countries. Originally, crashed ice was used to cause vasoconstriction and consequently diminish CT uptake to hair follicles during CT. Soon, this method turned out impractically and has been displaced by cooling caps which allow a constant cooling of the scalp while easy handling.
However, effectiveness of scalp cooling depends on different factors such as hair texture, chemotherapy regimen, dose of chemotherapy, cooling time, and compliance of the patient.
Recent studies focused on alopecia prevention more than on patients' quality of life and satisfaction. Therefore, data on routine use of cool caps with a focus on efficiency in daily routine and patients' acceptability are missing.
Patient-reported outcomes (PROs) provide results assessed by the use of a patient's report about his or her own health condition "without amendment or interpretation by a clinician or anyone else" and are a valuable source of information when evaluating clinical interventions or treatment toxicity in intervention studies in oncology. PROs can be perfectly used to evaluate the implication of scalp cooling regarding hair preservation but also quality of life outcome which seems even more important.
Women with breast- or gynecological cancer receiving taxane- or anthracycline-based neoadjuvant chemotherapy are included in the study. Chemotherapy can be neoadjuvant, adjuvant or palliative. Up to two lines of chemotherapy are allowed. Scalp cooling with a maintenance temperature of 17°C will be initiated 30 minutes prior to each chemotherapy cycle and stopped 90 minutes after CT. Patients are assessed for alopecia and qualitiy of life.
- Conditions
- Breast Cancer Female, Alopecia
- Being tested
- Paxman Scalp Cooling System, Alopecia Assessments
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paxman Scalp Cooling SystemDevice
All patients who accomplish inclusion criteria and do not exhibit any contraindication undergo scalp cooling with the following conditions:
- Minimum 30 minutes pre-infusion cooling
- Cooling for the duration of chemotherapy infusion
- Minimum 90 minutes post-infusion cooling Scalp cooling is performed within the study group at each CT session.
Alopecia AssessmentsOther
Patients (study group and reference group) will be assessed at the following time Points:
- Baseline
- at the half-way Point of the cyles
- at the last CT cycle
- 3 months after completion of Treatment
- 6-9 months after treatment completion
The assesments include the following
- Photographs of the head, which are evaluated using the CTCAEv4.0
- Questionnaire including the NCI- PRO-CTCAE-ITEMS, EORTC QLQ-C30, EORTC QLQ-B23, Body Image Scale, PRO-CTACAEs and Hairdex questionnaire
| Study group | Role | What they receive |
|---|---|---|
| study group | Patients with breast or gynecological cancer planning to undergo chemotherapy Chemotherapy can be neoadjuvant, adjuvant or palliative Up to two lines of chemotherapy are allowed. Adjuvant therapy counts as one line.
Chemotherapy regime is associated with alopecia. Chemotherapy must be planned for at least 4 cycles of taxane or antracycline- based chemotherapy regimen No alopecia of any reason (up-front) No overt cognitive impairment and fluent in German Written informed consent Age 18 and older Receives: Device: Paxman Scalp Cooling System; Other: Alopecia Assessments | |
| reference group | For the purpose of comparison, a reference sample will be included in the study applying to the following inclusion criteria:
Patients with breast or gynecological cancer planning to undergo chemotherapy Chemotherapy can be neoadjuvant, adjuvant or palliative Up to two lines of chemotherapy are allowed. Adjuvant therapy counts as one line.
Chemotherapy regime is associated with alopecia. Chemotherapy must be planned for at least 4 cycles of taxane or antracycline- based chemotherapy regimen Refuse to undergo scalp cooling Patients who have been excluded for the study group for the reason of migraine Written informed consent Age 18 and older
Patients from the reference group complete the same survey as the study group. Group comparisons will be adjusted for baseline body image and reasons for refusal. Receives: Other: Alopecia Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of hair preservation
Hair preservation assessed by photo documentation using VAS (Visual Analogue Scale (Grade 1: < 25% hair loss; Grade 2: 25-50% of hair loss; Grade 3: 50-75%)
Measured: on average of 15 month
Secondary outcomes (6)
Assessment of Adverse Events (CTCAE 4.03)
CTCAE are descriptive terminology for reporting adverse events including a grading for each of these adverse events. This 5-point grading has a range from mild symptoms requiring no intervention (grade 1) to life-threatening consequences (grade 4) and finally death (grade 5)
Measured: on average of 15 month
Assessment of patient satisfaction (HAIRDEX)
The Hairdex questionnaire is a reliable and valid instrument for the evaluation of quality of life in patients with hair diseases (i.e. validated in patients with alopecia diffusa and androgenica). Using a five-point Likert Scale (never=0 to always =4), the questionnaire encompasses 48 items composing the 5 subscales symptoms, functioning, emotionals, self-confidence and stigmatization. All scales range from 0-100, higher values indicate higher impairment.
Measured: on average of 15 month
Assessment of quality of life (EORTC) QLQ-C30
he EORTC QLQ-C30 Aaronson is a self-report measure consisting of 30 items with a 4 point Likert Scale response format. It targets on functioning (physical, role emotional, cognitive, and social functioning and global health/QoL scale) and symptoms (fatigue, nausea and emesis, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, financial difficulties). All scales and single items range from 0-100.
Measured: on average of 15 month
Assessment of quality of life (EORTC) BR23
The 23-item EORTC QLQ BR23 contains two breast cancer specific functional scales (body image and sexuality) and three symptom scales evaluating arm symptoms, breast symptoms, and systemic therapy symptoms. In addition, we include EORTC single items for hair loss.
Measured: on average of 15 month
Assessment of quality of life (Body Image Scale BIS)
It is a 10 items short instrument suitable for use in clinical trials. The BIS has a single sumscore; the response format is a 4-point Likert scale with high values indicating good body image.
Measured: on average of 15 month
Patient reported-outcomes Common Terminology Criteria for Adverse Events (PRO- CTCAE)
The PRO-CTCAE allow the assessment of those symptoms listed in the CTCAE that can be perceived by a patient him/herself. For most items PRO-CTCAE assesses symptom severity, but for some it covers also symptom frequency and interference with daily activities. In total, this PRO instrument covers 81 symptoms with 126 items using a 5-point Likert scale for grading. For the purpose of this study, we use the PRO-CTCAE-ITEMS (Item Library Version 1.0; Version date: 3/24/2016) Symptom Term: Hair loss.
Measured: on average of 15 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start18 May 2018
- Primary completion30 Apr 2020
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Marth, Prof Dr, Study chair, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117815
- Sponsor's protocol ID
- 1049/2018
- Status last verified
- Jan 2022
- First submitted
- 17 Jun 2019
- Last updated
- 20 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hair-Safe Study: Scalp Cooling for Hair Saving in Women Undergoing Chemotherapy
- ClinicalTrials.gov ID
- NCT04117815
- Acronym / sponsor ID
- 1049/2018
- Conditions
- Breast Cancer Female, Alopecia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 18 May 2018 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 7 Oct 2019 (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 (CT) is a frequent and well established treatment in women with breast and gynecological tumors. Alopecia is one of the most common side effects of CT seriously impairing patient quality of life and body image. While other CT associated side effects can be controlled by supportive treatment strategy, adequate preventive measures for alopecia have been lacking. New evidence supports the efficacy of scalp cooling for alopecia prevention during CT.
Detailed description
Scalp cooling using cooling caps has been identified as an effective treatment option against CT-induced alopecia in numerous European countries. Originally, crashed ice was used to cause vasoconstriction and consequently diminish CT uptake to hair follicles during CT. Soon, this method turned out impractically and has been displaced by cooling caps which allow a constant cooling of the scalp while easy handling.
However, effectiveness of scalp cooling depends on different factors such as hair texture, chemotherapy regimen, dose of chemotherapy, cooling time, and compliance of the patient.
Recent studies focused on alopecia prevention more than on patients' quality of life and satisfaction. Therefore, data on routine use of cool caps with a focus on efficiency in daily routine and patients' acceptability are missing.
Patient-reported outcomes (PROs) provide results assessed by the use of a patient's report about his or her own health condition "without amendment or interpretation by a clinician or anyone else" and are a valuable source of information when evaluating clinical interventions or treatment toxicity in intervention studies in oncology. PROs can be perfectly used to evaluate the implication of scalp cooling regarding hair preservation but also quality of life outcome which seems even more important.
Women with breast- or gynecological cancer receiving taxane- or anthracycline-based neoadjuvant chemotherapy are included in the study. Chemotherapy can be neoadjuvant, adjuvant or palliative. Up to two lines of chemotherapy are allowed. Scalp cooling with a maintenance temperature of 17°C will be initiated 30 minutes prior to each chemotherapy cycle and stopped 90 minutes after CT. Patients are assessed for alopecia and qualitiy of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | Device: Paxman Scalp Cooling System, Other: Alopecia AssessmentsPatients with breast or gynecological cancer planning to undergo chemotherapy Chemotherapy can be neoadjuvant, adjuvant or palliative Up to two lines of chemotherapy are allowed. Adjuvant therapy counts as one line. Chemotherapy regime is associated with alopecia. Chemotherapy must be planned for at least 4 cycles of taxane or antracycline- based chemotherapy regimen No alopecia of any reason (up-front) No overt cognitive impairment and fluent in German Written informed consent Age 18 and older |
| reference group | – | Other: Alopecia AssessmentsFor the purpose of comparison, a reference sample will be included in the study applying to the following inclusion criteria: Patients with breast or gynecological cancer planning to undergo chemotherapy Chemotherapy can be neoadjuvant, adjuvant or palliative Up to two lines of chemotherapy are allowed. Adjuvant therapy counts as one line. Chemotherapy regime is associated with alopecia. Chemotherapy must be planned for at least 4 cycles of taxane or antracycline- based chemotherapy regimen Refuse to undergo scalp cooling Patients who have been excluded for the study group for the reason of migraine Written informed consent Age 18 and older Patients from the reference group complete the same survey as the study group. Group comparisons will be adjusted for baseline body image and reasons for refusal. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study is designed as a clinical trial for women with breast or gyneological cancer, planning to undergo taxane- or anthracyline-based CT in a routine clinical setting. For the purpose of comparison, a reference sample is included in the study.
Key inclusion criteria (6 listed)
- Patients with breast or gynecological cancer planning to undergo CT
- CT can be neoadjuvant, adjuvant or palliative
- Up to two lines of CT are allowed. Adjuvant therapy counts as one line
- CT regime is associated with alopecia
- CT must be planned for at least 4 cycles of taxane or anthracyline-based CT regimen
Key exclusion criteria (16 listed)
- Migraine
- Cold allergy/Cold Agglutinins/Morbus Raynaud
- Hematological malignancies (Leukemia, non Hodgkins and other generalized lymphomas)
- Manifest scalp metastases
- Overt cognitive impairment
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 |
|---|---|---|
| Paxman Scalp Cooling SystemAll patients who accomplish inclusion criteria and do not exhibit any contraindication undergo scalp cooling with the following conditions: * Minimum 30 minutes pre-infusion cooling * Cooling for the duration of chemotherapy infusion * Minimum 90 minutes post-infusion cooling Scalp cooling is performed within the study group at each CT session. | Device | study group |
| Alopecia AssessmentsPatients (study group and reference group) will be assessed at the following time Points: * Baseline * at the half-way Point of the cyles * at the last CT cycle * 3 months after completion of Treatment * 6-9 months after treatment completion The assesments include the following * Photographs of the head, which are evaluated using the CTCAEv4.0 * Questionnaire including the NCI- PRO-CTCAE-ITEMS, EORTC QLQ-C30, EORTC QLQ-B23, Body Image Scale, PRO-CTACAEs and Hairdex questionnaire | Other | reference group, study group |
Primary outcome
Extent of hair preservation
Time frame: on average of 15 month
Hair preservation assessed by photo documentation using VAS (Visual Analogue Scale (Grade 1: < 25% hair loss; Grade 2: 25-50% of hair loss; Grade 3: 50-75%)
6 secondary outcomes
Assessment of Adverse Events (CTCAE 4.03)
Time frame: on average of 15 month
Assessment of patient satisfaction (HAIRDEX)
Time frame: on average of 15 month
Assessment of quality of life (EORTC) QLQ-C30
Time frame: on average of 15 month
Assessment of quality of life (EORTC) BR23
Time frame: on average of 15 month
Assessment of quality of life (Body Image Scale BIS)
Time frame: on average of 15 month
Patient reported-outcomes Common Terminology Criteria for Adverse Events (PRO- CTCAE)
Time frame: on average of 15 month
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 20 Jan 2022.
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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.
Christian Marth, Prof Dr study chair
Medical University Innsbruck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Female and Alopecia, run by Medical University Innsbruck at 1 site in Austria.
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 6 inclusion and 16 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 20 Jan 2022. 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 Austria. 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?
Extent of hair preservation (time frame: on average of 15 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2022.