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

NCT04117815 | Completed FDA Device

• 1 other identifier: 1049/2018
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female; Alopecia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Assessment of Adverse Events (CTCAE 4.03)

  on average of 15 month

• Assessment of patient satisfaction (HAIRDEX)

  on average of 15 month

• Assessment of quality of life (EORTC) QLQ-C30

  on average of 15 month

• Assessment of quality of life (EORTC) BR23

  on average of 15 month

• Assessment of quality of life (Body Image Scale BIS)

  on average of 15 month

Study Arms (2)

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

Device: Paxman Scalp Cooling System; Other: Alopecia Assessments

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.

Other: Alopecia Assessments

Interventions

Paxman Scalp Cooling System 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.

study group

Alopecia Assessments 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; study group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Medical University Innsbruck, Department of Gynaecology and Obstetrics

Innsbruck, Tyrol, 6020, Austria

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Christian Marth, Prof Dr

  Medical University Innsbruck

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: October 7, 2019
• Study Start: May 18, 2018
• Primary Completion: April 30, 2020
• Study Completion: February 28, 2021
• Last Updated: January 20, 2022

Record last verified: 2022-01

Locations

AU (1)