Back to resultsScalp Cooling to Prevent Chemo-induced Hair Loss (SCALP)
Primary Purpose
Breast Cancer, Alopecia
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PAXMAN Orbis Scalp Cooler
Control No treatment
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, Alopecia, Scalp, Cooling
Eligibility 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
Sites / Locations
- Hematology & Oncology Associates of Northern New Jersey
- Memorial Sloan Kettering Cancer Center
- Cleveland Clinic
- Texas Oncology - Medical City Dallas
- Texas Oncology-Baylor Charles A. Sammons Cancer Center
- USOncology / Texas Oncology-Memorial City
- Lester and Sue Smith Breast Center at Baylor College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
PAXMAN Orbis Scalp Cooler
Control No treatment
Arm Description
Scalp Cooling
Control
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Time to First Recurrence and Overall Survival
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01986140
Brief Title
Scalp Cooling to Prevent Chemo-induced Hair Loss
Acronym
SCALP
Official Title
Scalp Cooling for Alopecia Prevention (SCALP)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 15, 2014 (Actual)
Primary Completion Date
February 10, 2017 (Actual)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Julie Nangia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Alopecia
Keywords
Breast Cancer, Alopecia, Scalp, Cooling
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Masking Description
One blinded observer assesses the patient outcome
Allocation
Randomized
Enrollment
236 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PAXMAN Orbis Scalp Cooler
Arm Type
Experimental
Arm Description
Scalp Cooling
Arm Title
Control No treatment
Arm Type
Other
Arm Description
Control
Intervention Type
Device
Intervention Name(s)
PAXMAN Orbis Scalp Cooler
Intervention Description
Treatment with Orbis scalp cooling cap
Intervention Type
Other
Intervention Name(s)
Control No treatment
Other Intervention Name(s)
No intervention
Intervention Description
No treatment to prevent hair loss
Primary Outcome Measure Information:
Title
Hair Preservation
Description
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.
Time Frame
4 to 8 Months
Secondary Outcome Measure Information:
Title
Time to First Recurrence and Overall Survival
Description
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
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
Improved Quality of Life
Description
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.
Time Frame
4 to 8 Months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Nangia, M.D.
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hematology & Oncology Associates of Northern New Jersey
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Texas Oncology - Medical City Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Texas Oncology-Baylor Charles A. Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
USOncology / Texas Oncology-Memorial City
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Lester and Sue Smith Breast Center at Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
35915020
Citation
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.
Results Reference
derived
PubMed Identifier
28196254
Citation
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.
Results Reference
derived
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Scalp Cooling to Prevent Chemo-induced Hair Loss
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