NCT01986140

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
236

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 18, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

May 15, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2017

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

October 16, 2018

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

July 27, 2021

Status Verified

July 1, 2021

Enrollment Period

2.7 years

First QC Date

November 11, 2013

Results QC Date

July 13, 2018

Last Update Submit

July 25, 2021

Conditions

Breast CancerAlopecia

Keywords

Breast CancerAlopeciaScalpCooling

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Time to First Recurrence and Overall Survival

    5 years

Other Outcomes (1)

  • Improved Quality of Life

    4 to 8 Months

Study Arms (2)

PAXMAN Orbis Scalp Cooler

EXPERIMENTAL

Scalp Cooling

Device: PAXMAN Orbis Scalp Cooler

Control No treatment

OTHER

Control

Other: Control No treatment

Interventions

PAXMAN Orbis Scalp CoolerDEVICE

Treatment with Orbis scalp cooling cap

PAXMAN Orbis Scalp Cooler
Control No treatmentOTHER

No treatment to prevent hair loss

Also known as: No intervention
Control No treatment

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Hematology & Oncology Associates of Northern New Jersey

Morristown, New Jersey, 07962, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Texas Oncology - Medical City Dallas

Dallas, Texas, 75230, United States

Location

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

USOncology / Texas Oncology-Memorial City

Houston, Texas, 77024, United States

Location

Lester and Sue Smith Breast Center at Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (2)

  • Chevli N, Wang K, Haque W, Schwartz MR, Nangia J, Sasaki J, Farach AM, Hatch SS, Butler EB, Teh BS. Prognostic Impact of Radiation Therapy in Pure Mucinous Breast Carcinoma. Clin Breast Cancer. 2022 Oct;22(7):e807-e817. doi: 10.1016/j.clbc.2022.06.005. Epub 2022 Jul 7.

    PMID: 35915020DERIVED

  • Nangia J, Wang T, Osborne C, Niravath P, Otte K, Papish S, Holmes F, Abraham J, Lacouture M, Courtright J, Paxman R, Rude M, Hilsenbeck S, Osborne CK, Rimawi M. Effect of a Scalp Cooling Device on Alopecia in Women Undergoing Chemotherapy for Breast Cancer: The SCALP Randomized Clinical Trial. JAMA. 2017 Feb 14;317(6):596-605. doi: 10.1001/jama.2016.20939.

    PMID: 28196254DERIVED

MeSH Terms

Conditions

Breast NeoplasmsAlopecia

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesHypotrichosisHair DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Tao Wang
Organization
Baylor College of Medicine
taow@bcm.edu
7137985388

Study Officials

  • Julie Nangia, M.D.

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
One blinded observer assesses the patient outcome
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 11, 2013

First Posted

November 18, 2013

Study Start

May 15, 2014

Primary Completion

February 10, 2017

Study Completion

December 1, 2022

Last Updated

July 27, 2021

Results First Posted

October 16, 2018

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share

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

Shared Documents
ICF
Time Frame
At completion of their participation.
Access Criteria
Patients know if they are wearing the device or not.

Locations

US(7)