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

• ClinicalTrials.gov Identifier: NCT01986140
• Recruitment Status: Unknown
• First Posted: November 18, 2013
• Results First Posted: October 16, 2018
• Last Update Posted: July 27, 2021
• Sponsor: Julie Nangia
• Information provided by (Responsible Party): Julie Nangia, Baylor Breast Care Center

Tracking Information

• First Submitted Date: November 11, 2013
• First Posted Date: November 18, 2013
• Results First Submitted Date: July 13, 2018
• Results First Posted Date: October 16, 2018
• Last Update Posted Date: July 27, 2021
• Actual Study Start Date: May 15, 2014
• Actual Primary Completion Date: February 10, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 18, 2018)

Hair Preservation [ Time Frame: 4 to 8 Months ]

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.

• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: September 18, 2018)

Time to First Recurrence and Overall Survival [ Time Frame: 5 years ]

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

• Original Secondary Outcome Measures: Not Provided

Current Other Pre-specified Outcome Measures (submitted: December 30, 2013)

Improved Quality of Life [ Time Frame: 4 to 8 Months ]

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.

• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Scalp Cooling to Prevent Chemo-induced Hair Loss
• Official Title: Scalp Cooling for Alopecia Prevention (SCALP)
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Masking Description:

One blinded observer assesses the patient outcome

Primary Purpose: Treatment

Condition

• Breast Cancer
• Alopecia

Intervention

• Device: PAXMAN Orbis Scalp Cooler
  Treatment with Orbis scalp cooling cap
• Other: Control No treatment
  No treatment to prevent hair loss
  Other Name: No intervention

Study Arms

• Experimental: PAXMAN Orbis Scalp Cooler
  Scalp Cooling
  Intervention: Device: PAXMAN Orbis Scalp Cooler
• Control No treatment
  Control
  Intervention: Other: Control No treatment

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: September 18, 2018): 236
• Original Enrollment: Not Provided
• Estimated Study Completion Date: December 2022
• Actual Primary Completion Date: February 10, 2017 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01986140
• Other Study ID Numbers: H: 33692 SCALP
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• 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.
• Supporting Materials: Informed Consent Form (ICF)
• Time Frame: At completion of their participation.
• Access Criteria: Patients know if they are wearing the device or not.

• Current Responsible Party: Julie Nangia, Baylor Breast Care Center
• Original Responsible Party: [Redacted]
• Current Study Sponsor: Julie Nangia
• Original Study Sponsor: [Redacted]
• Collaborators: Not Provided

Investigators

• Principal Investigator: Julie Nangia, M.D.; Baylor College of Medicine

• PRS Account: Baylor Breast Care Center
• Verification Date: July 2021