Breast Cancer Female Clinical Trial
Official title:
Hair-Safe Study: Scalp Cooling for Hair Saving in Women Undergoing Chemotherapy
NCT number | NCT04117815 |
Other study ID # | 1049/2018 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 18, 2018 |
Est. completion date | February 28, 2021 |
Verified date | January 2022 |
Source | Medical University Innsbruck |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 128 |
Est. completion date | February 28, 2021 |
Est. primary completion date | April 30, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 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 |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University Innsbruck, Department of Gynaecology and Obstetrics | Innsbruck | Tyrol |
Lead Sponsor | Collaborator |
---|---|
Medical University Innsbruck |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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%) | on average of 15 month | |
Secondary | 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) | on average of 15 month | |
Secondary | 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. | on average of 15 month | |
Secondary | 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. | on average of 15 month | |
Secondary | 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. | on average of 15 month | |
Secondary | 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. | on average of 15 month | |
Secondary | 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. | on average of 15 month |
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