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

NCT ID: NCT04117815

Last Updated: 2022-01-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 128 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-18
• Study Completion Date: 2021-02-28

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.

Conditions

Breast Cancer Female; Alopecia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Paxman Scalp Cooling System

Intervention Type: DEVICE

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 Assessments

Intervention Type: OTHER

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

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.

Alopecia Assessments

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DEVICE

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medical University Innsbruck

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian Marth, Prof Dr

Role: STUDY_CHAIR

Medical University Innsbruck

Locations

Medical University Innsbruck, Department of Gynaecology and Obstetrics

Innsbruck, Tyrol, Austria

Countries

Austria

Other Identifiers

1049/2018

Identifier Type: -

Identifier Source: org_study_id