Clinical trial NCT04117815: Hair-Safe Study: Scalp Cooling for Hair Saving in Women Undergoing Chemotherapy
Official title: Hair-Safe Study: Scalp Cooling for Hair Saving in Women Undergoing Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer Female
Alopecia
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2019-10-07
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Extent of hair preservation
timeFrame: on average of 15 month
Secondary outcomes:
measure: Assessment of Adverse Events (CTCAE 4.03)
timeFrame: on average of 15 month
measure: Assessment of patient satisfaction (HAIRDEX)
timeFrame: on average of 15 month
measure: Assessment of quality of life (EORTC) QLQ-C30
timeFrame: on average of 15 month
measure: Assessment of quality of life (EORTC) BR23
timeFrame: on average of 15 month
measure: Assessment of quality of life (Body Image Scale BIS)
timeFrame: on average of 15 month
measure: Patient reported-outcomes Common Terminology Criteria for Adverse Events (PRO- CTCAE)
timeFrame: on average of 15 month
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University Innsbruck, Department of Gynaecology and Obstetrics
state: Tyrol
Study officials:
affiliation: Medical University Innsbruck
name: Christian Marth, Prof Dr
role: STUDY_CHAIR
References: