Scalp Cooling to Prevent Chemo-induced Hair Loss

Breast Cancer Clinical Trial

— SCALP  

Official title:

Scalp Cooling for Alopecia Prevention (SCALP)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01986140
• Other study ID #: H: 33692 SCALP
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 15, 2014
• Est. completion date: December 2022

Study information

• Verified date: July 2021
• Source: Baylor Breast Care Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Determine that the Orbis Paxman Hair Loss Prevention System is safe and effective in reducing chemotherapy-induced alopecia in woman with breast cancer undergoing neoadjuvant or adjuvant chemotherapy.

Description:

Cooling the scalp during chemotherapy may help reduce the chances of losing hair during treatment. The investigators are hoping that using the PAXMAN Orbis Scalp Cooling Device may stop patients who are undergoing chemotherapy from losing their hair.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 236
• Est. completion date: December 2022
• Est. primary completion date: February 10, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• New diagnosis of breast cancer stage 1-2

• Planning to undergo neoadjuvant or adjuvant chemotherapy with curative intent

• Chemotherapy must be planned for at least 4 cycles of full-dose anthracycline or taxane based chemotherapy regimen,

• Defined as one of the following regimens: - Adriamycin 60mg/m2 with cyclophosphamide 600mg/m2 - Epirubicin 90-100mg/m2 with cyclophosphamide 600mg/m2 - Doxorubicin 50mg/m2 with 5-Fluroruacil 500mg/m2 and Cyclophosphamide 500mg/m2 - Paclitaxel 80mg-90/m2 weekly (every three weeks constitute a cycle), or 175 mg/m2 every 2-3 weeks as a single agent - Docetaxel 100mg/m2 as a single agent - Docetaxel 75mg/m2-100mg/m2 with pertuzumab and traztuzumab at standard doses - Docetaxel 75mg/m2 with cyclophosphamide 600mg/m2 - Docetaxel 75mg/m2 with carboplatin AUC of 6 and trastuzumab at standard doses

• Concurrent traztuzumab at standard doses is allowed

• Concurrent pertuzumab at standard doses is allowed

• Administration of chemotherapy on a dose dense schedule is allowed as clinically indicated.

• Subjects must have TSH collected within 1 year prior to treatment and found within normal range.

• If patient has a history of diabetes, Hemoglobin A1c must be drawn within 3 months prior to treatment and found to be within normal limits.

• CBC and CMP should be done within 4 weeks prior to treatment and found to be within acceptable limits.

Exclusion Criteria:

• Stage 3 or 4 breast cancer or any other concurrent malignancy including hematological malignancies (i.e. leukemia or lymphoma)

• Baseline alopecia (defined CTCAE v4.0 grade > 0, see appendix B for CTCAE v4.0 scale)

• Subjects with cold agglutinin disease or cold urticaria

• Subjects who are scheduled for bone marrow ablation chemotherapy

• Subjects receiving chemotherapy with concurrent anthracycline and taxane (AT or TAC)

• Male gender

• Age >= 70 years

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Breast Cancer

Intervention

Device:
• PAXMAN Orbis Scalp Cooler
Treatment with Orbis scalp cooling cap

Other:
• Control No treatment
No treatment to prevent hair loss

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio
United States	Texas Oncology - Medical City Dallas	Dallas	Texas
United States	Texas Oncology-Baylor Charles A. Sammons Cancer Center	Dallas	Texas
United States	Lester and Sue Smith Breast Center at Baylor College of Medicine	Houston	Texas
United States	USOncology / Texas Oncology-Memorial City	Houston	Texas
United States	Hematology & Oncology Associates of Northern New Jersey	Morristown	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Julie Nangia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Improved Quality of Life	Improved quality of life as a result of reduced hair loss is a primary motivator for developing the Paxman Scalp Cooling device. Quality of life will be assessed at baseline and 2-3 weeks after each course of chemotherapy. Three widely used and validated scales will be used: the EORTC QLQ C-30, HADS and BIS. Subjects will be evaluated at multiple time points and data will be analyzed using descriptive methods with median and inter quartile rang to assess the effect of treatment group and alopecia status on functioning, quality of life and depression.	4 to 8 Months
Primary	Hair Preservation	The primary efficacy endpoint will be success in hair preservation, defined as CTCAE v 4 alopecia grade <2, and will be assessed by a healthcare professional who is blinded to study treatment.	4 to 8 Months
Secondary	Time to First Recurrence and Overall Survival	A safety follow-up for safety data will be done yearly for 5 years looking at time to first recurrence of breast cancer, overall survival, site of first recurrence, and incidence of isolated scalp metastasis. This will be collected during routine clinical observation	5 years