Breast CancerSCALPNCT01986140
Scalp Cooling to Prevent Chemo-induced Hair Loss
A study testing PAXMAN Orbis Scalp Cooler in people with Breast Cancer and Alopecia, run by Julie Nangia at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Alopecia
- What is being tested?
- PAXMAN Orbis Scalp Cooler
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 7 sitesUnited States
- Study dates
- 15 May 2014to Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Cleveland Clinic
Cleveland, Ohio, 44195
Texas Oncology - Medical City Dallas
Dallas, Texas, 75230
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
USOncology / Texas Oncology-Memorial City
Houston, Texas, 77024
Lester and Sue Smith Breast Center at Baylor College of Medicine
Houston, Texas, 77030
Hematology & Oncology Associates of Northern New Jersey
Morristown, New Jersey, 07962
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Scalp Cooling for Alopecia Prevention (SCALP)
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.
Read the 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.
- Conditions
- Breast Cancer, Alopecia
- Being tested
- PAXMAN Orbis Scalp Cooler, Control No treatment
- Keywords
- Breast Cancer, Alopecia, Scalp, Cooling
- Medical subject headings
- Breast Neoplasms, Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAXMAN Orbis Scalp CoolerDevice
Treatment with Orbis scalp cooling cap
Control No treatmentOther
Also called No intervention
No treatment to prevent hair loss
| Study group | Role | What they receive |
|---|---|---|
| PAXMAN Orbis Scalp Cooler | Experimental | Scalp Cooling Receives: Device: PAXMAN Orbis Scalp Cooler |
| Control No treatment | Other | Control Receives: Other: Control No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 to 8 Months
Secondary outcomes (1)
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2013 (estimated)
- Study start15 May 2014
- Primary completion10 Feb 2017
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Julie Nangia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Julie Nangia, Baylor Breast Care Center
- Investigators
- Julie Nangia, M.D., Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986140
- Sponsor's protocol ID
- H: 33692 SCALP
- Acronym
- SCALP
- Status last verified
- Jul 2021
- First submitted
- 11 Nov 2013
- Last updated
- 27 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Patients are aware of whether or not they are using the cooling device and can tell if they have hair loss.
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.
PubMed 35915020Nangia 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.
PubMed 28196254
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scalp Cooling for Alopecia Prevention (SCALP)
- ClinicalTrials.gov ID
- NCT01986140
- Acronym / sponsor ID
- SCALP / H: 33692 SCALP
- Conditions
- Breast Cancer, Alopecia
- Keywords
- Breast Cancer, Alopecia, Scalp, Cooling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Julie NangiaUniversity, hospital or other
- Study start
- 15 May 2014 (actual)
- Primary completion
- 10 Feb 2017 (actual)
- Study completion
- Dec 2022 (estimated)
- First posted
- 18 Nov 2013 (estimated)
- Results
- Posted 16 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAXMAN Orbis Scalp Cooler | Experimental | Device: PAXMAN Orbis Scalp CoolerScalp Cooling |
| Control No treatment | Other | Other: Control No treatmentControl |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAXMAN Orbis Scalp CoolerTreatment with Orbis scalp cooling cap | Device | PAXMAN Orbis Scalp Cooler |
| Control No treatmentAlso: No interventionNo treatment to prevent hair loss | Other | Control No treatment |
Primary outcome
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.
1 secondary outcome
Time to First Recurrence and Overall Survival
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35915020Chevli 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.
- Derived from this study: PubMed 28196254Nangia 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.
- Individual participant dataSharing planned: Yes. Patients are aware of whether or not they are using the cooling device and can tell if they have hair loss.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Nangia, M.D. principal investigator
Baylor College of Medicine
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAXMAN Orbis Scalp Cooler in people with Breast Cancer and Alopecia, run by Julie Nangia at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hair Preservation (time frame: 4 to 8 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01986140, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021.