NCT04117815

Hair-Safe Study: Scalp Cooling for Hair Saving in Women Undergoing Chemotherapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 128 (actual)
• Sponsor: Medical University Innsbruck · Academic / Other
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer Female
• Alopecia

Interventions

Type	Name	Description
DEVICE	Paxman Scalp Cooling System	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.
OTHER	Alopecia Assessments	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

Timeline

• Start date: 2018-05-18
• Primary completion: 2020-04-30
• Completion: 2021-02-28
• First posted: 2019-10-07
• Last updated: 2022-01-20

Locations

1 site across 1 country: Austria

Regulatory

• FDA-regulated device study