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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Julie Nangia, Baylor Breast Care Center
ClinicalTrials.gov Identifier:
NCT01986140
First received: November 11, 2013
Last updated: December 2, 2016
Last verified: December 2016
  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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.


Enrollment: 235
Study Start Date: December 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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   (Adult, Senior)
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

Locations
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
Principal Investigator: Julie Nangia, M.D. Baylor College of Medicine
  More Information

Responsible Party: Julie Nangia, Assistant Professor, 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: December 2, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
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.

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

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on December 08, 2016