Clinical trial NCT01986140: Scalp Cooling to Prevent Chemo-induced Hair Loss
Official title: Scalp Cooling for Alopecia Prevention (SCALP)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Alopecia
Keywords: Breast Cancer
Alopecia
Scalp
Cooling
Lead sponsor: Baylor Breast Care Center
Sponsor class: OTHER
First posted: 2013-11-18
Enrollment: 236
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hair Preservation
timeFrame: 4 to 8 Months
Secondary outcomes:
measure: Time to First Recurrence and Overall Survival
timeFrame: 5 years
Other outcomes:
measure: Improved Quality of Life
timeFrame: 4 to 8 Months
Locations:
city: Morristown
country: United States
facility: Hematology & Oncology Associates of Northern New Jersey
state: New Jersey
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Dallas
country: United States
facility: Texas Oncology - Medical City Dallas
state: Texas
city: Dallas
country: United States
facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center
state: Texas
city: Houston
country: United States
facility: USOncology / Texas Oncology-Memorial City
state: Texas
city: Houston
country: United States
facility: Lester and Sue Smith Breast Center at Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Julie Nangia, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.