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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Baylor Breast Care Center
Sponsor:
Information provided by (Responsible Party):
Baylor Breast Care Center
ClinicalTrials.gov Identifier:
NCT01986140
First received: November 11, 2013
Last updated: November 18, 2014
Last verified: November 2014
  Purpose

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 Intervention Phase
Breast Cancer
Alopecia
Device: PAXMAN Orbis Scalp Cooler
Other: Control No treatment to prevent hair loss
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Scalp Cooling for Alopecia Prevention (SCALP)

Resource links provided by NLM:


Further study details as provided by Baylor Breast Care Center:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 4 to 8 Months ] [ Designated as safety issue: No ]
    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:
  • Safety [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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:
  • Improved Quality of Life [ Time Frame: 4 to 8 Months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 235
Study Start Date: December 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Scalp Cooling
Scalp Cooling
Device: PAXMAN Orbis Scalp Cooler
Treatment with Orbis scalp cooling cap
Other Name: PAXMAN Orbis Scalp Cooler
Control
Control
Other: Control No treatment to prevent hair loss
No treatment to prevent hair loss
Other Name: No intervention

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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 - 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 with cyclophosphamide 600mg/m2 - Docetaxel 75mg/m2 with carboplatin AUC of 6 and trastuzumab at standard doses
  • Trastuzumab at standard doses is allowed in combination with taxane based chemotherapy
  • Administration of chemotherapy on a dose dense schedule is allowed as clinically indicated.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01986140

Contacts
Contact: Kristen Otte 713-798-1999 kristen.otte@bcm.edu
Contact: Claudette Foreman 713-798-7315 caforema@bcm.edu

Locations
United States, New Jersey
Hematology & Oncology Associates of Northern New Jersey Recruiting
Morristown, New Jersey, United States, 07962
Contact: Michelle Mackenzie    973-538-3593 ext 2338    mmackenzie@hoannj.com   
Contact: Karen Fritsch    973-538-3593    kfritsch@hoannj.com   
Principal Investigator: Steven Papish, MD         
United States, Texas
Texas Oncology-Baylor Charles A. Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Contact: Laurel Andrews    214-370-1000    lori.andrews@usoncology.com   
Contact: Francis Collins    (214)370-1000    francis.collins@usoncology.com   
Principal Investigator: Cynthia Osborne, MD         
Lester and Sue Smith Breast Center at Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Kristen Otte, BS    713-798-1999    Kristen.Otte@bcm.edu   
Contact: Brenda Reusser, BA    713-798-1929    breusser@bcm.edu   
Sub-Investigator: Polly Niravath, MD         
Sub-Investigator: Mothaffar Rimawi, MD         
Sub-Investigator: Kent Osborne, MD         
Sub-Investigator: Mari Rude, NP         
Sub-Investigator: Sao Jiralerspong, MD         
USOncology / Texas Oncology-Memorial City Recruiting
Houston, Texas, United States, 77024
Contact: Amber Mendoza    713-467-1722    amber.mendoza@usoncology.com   
Contact: Jamie Renard    713-467-1722    jamie.renard@usoncology.com   
Principal Investigator: Frankie Holmes, MD         
Sponsors and Collaborators
Baylor Breast Care Center
Investigators
Principal Investigator: Julie Nangia, M.D. Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Baylor Breast Care Center
ClinicalTrials.gov Identifier: NCT01986140     History of Changes
Other Study ID Numbers: H: 33692 SCALP
Study First Received: November 11, 2013
Last Updated: November 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Baylor Breast Care Center:
Breast Cancer
Alopecia
Scalp
Cooling

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Breast Neoplasms
Breast Diseases
Hair Diseases
Hypotrichosis
Neoplasms
Neoplasms by Site
Pathological Conditions, Anatomical
Skin Diseases

ClinicalTrials.gov processed this record on November 20, 2014