Hair-Safe Study: Scalp Cooling for Hair Saving in Women Undergoing Chemotherapy
Condition: Breast Cancer Female; Alopecia
MeSH terms: Alopecia
Study type: Observational

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.
    

Intervention name(s): Paxman Scalp Cooling System; Alopecia Assessments
Intervention type(s): Device; Other
Intervention description(s): 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.; 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
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.