Scalp Cooling to Prevent Chemo-induced Hair Loss (SCALP)

July 25, 2021 updated by: Julie Nangia

Scalp Cooling for Alopecia Prevention (SCALP)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

236

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Morristown, New Jersey, United States, 07962
        • Hematology & Oncology Associates of Northern New Jersey
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Texas
      • Dallas, Texas, United States, 75246
        • Texas Oncology-Baylor Charles A. Sammons Cancer Center
      • Dallas, Texas, United States, 75230
        • Texas Oncology - Medical City Dallas
      • Houston, Texas, United States, 77030
        • Lester and Sue Smith Breast Center at Baylor College of Medicine
      • Houston, Texas, United States, 77024
        • USOncology / Texas Oncology-Memorial City

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PAXMAN Orbis Scalp Cooler
Scalp Cooling
Device: PAXMAN Orbis Scalp Cooler
Treatment with Orbis scalp cooling cap
OTHER: Control No treatment
Control
Other: Control No treatment
No treatment to prevent hair loss
Other Names:
  • No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hair Preservation
Time Frame: 4 to 8 Months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Recurrence and Overall Survival
Time Frame: 5 years
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improved Quality of Life
Time Frame: 4 to 8 Months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Julie Nangia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 15, 2014

Primary Completion (ACTUAL)

February 10, 2017

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

November 11, 2013

First Submitted That Met QC Criteria

November 15, 2013

First Posted (ESTIMATE)

November 18, 2013

Study Record Updates

Last Update Posted (ACTUAL)

July 27, 2021

Last Update Submitted That Met QC Criteria

July 25, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H: 33692 SCALP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patients are aware of whether or not they are using the cooling device and can tell if they have hair loss.

IPD Sharing Time Frame

At completion of their participation.

IPD Sharing Access Criteria

Patients know if they are wearing the device or not.

IPD Sharing Supporting Information Type

  • ICF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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