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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01986140
Recruitment Status : Unknown
Verified July 2021 by Julie Nangia, Baylor Breast Care Center.
Recruitment status was:  Active, not recruiting
First Posted : November 18, 2013
Results First Posted : October 16, 2018
Last Update Posted : July 27, 2021
Sponsor:
Information provided by (Responsible Party):
Julie Nangia, Baylor Breast Care Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Alopecia Device: PAXMAN Orbis Scalp Cooler Other: Control No treatment Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Masking Description: One blinded observer assesses the patient outcome
Primary Purpose: Treatment
Official Title: Scalp Cooling for Alopecia Prevention (SCALP)
Actual Study Start Date : May 15, 2014
Actual Primary Completion Date : February 10, 2017
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: PAXMAN Orbis Scalp Cooler
Scalp Cooling
 Device: PAXMAN Orbis Scalp Cooler
Treatment with Orbis scalp cooling cap
Control No treatment
Control
 Other: Control No treatment
No treatment to prevent hair loss
Other Name: No intervention


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986140


Locations
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United States, New Jersey
Hematology & Oncology Associates of Northern New Jersey
Morristown, New Jersey, United States, 07962
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Texas
Texas Oncology - Medical City Dallas
Dallas, Texas, United States, 75230
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
USOncology / Texas Oncology-Memorial City
Houston, Texas, United States, 77024
Lester and Sue Smith Breast Center at Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Julie Nangia
Investigators
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Principal Investigator: Julie Nangia, M.D. Baylor College of Medicine
  Study Documents (Full-Text)

Documents provided by Julie Nangia, Baylor Breast Care Center:
Study Protocol  [PDF] July 1, 2016
Statistical Analysis Plan  [PDF] November 30, 2015
Informed Consent Form  [PDF] July 6, 2016

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Julie Nangia, Assistant Professor, Baylor Breast Care Center
ClinicalTrials.gov Identifier: NCT01986140    
Other Study ID Numbers: H: 33692 SCALP
First Posted: November 18, 2013    Key Record Dates
Results First Posted: October 16, 2018
Last Update Posted: July 27, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patients are aware of whether or not they are using the cooling device and can tell if they have hair loss.
Supporting Materials: Informed Consent Form (ICF)
Time Frame: At completion of their participation.
Access Criteria: Patients know if they are wearing the device or not.
Keywords provided by Julie Nangia, Baylor Breast Care Center:
Breast Cancer
Alopecia
Scalp
Cooling
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Skin Diseases
 Hypotrichosis
Hair Diseases
Pathological Conditions, Anatomical