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Clinical Studies

New Studies

In order to improve our system and service, we are continually investing in new research and testing around the world. The Paxman Scalp Cooling System is currently being tested in a number of clinical trials in various countries. We look forward to announcing the results soon.

New countries with ongoing trials:

  • United States of America (no longer recruiting participants)
  • Germany
  • Austria
  • Holland
  • Japan
  • India

Future trials:

  • Spain

Recruiting:

If you are a new patient and you are interested in becoming part of a study in your country, please contact the Paxman team.

Multi Centre US Clinical Trials

The Paxman Scalp Cooling System, also known as the 'Paxman cold cap', is under clinical investigation in the United States and is limited by federal law to investigational use. The Paxman Scalp Cooling System has not been approved by the US FDA and is currently not available for sale in the United States. This material should be considered informational only and does not constitute an offer to sell in any jurisdiction in which the product is not yet permitted to be sold.

SCALP - Scalp Cooling for Alopecia Prevention

Verified by Baylor Breast Care Center, September 2015.

Paxman, the leading global expert in scalp cooling for cancer chemotherapy patients, has been granted Investigational Device Exemption (IDE) approval by the US Food and Drug Administration FDA and the multi-centre trial of the patented Paxman Scalp Cooling System for the prevention of chemotherapy induced alopecia will be conducted with 235 patients across a number of medical centres throughout the US.

Sponsor

Baylor Breast Care Center

ClinicalTrials.gov Identifier

NCT01986140

Purpose

Determine that the Paxman Scalp Cooling System is safe and effective in reducing chemotherapy-induced alopecia in women with breast cancer undergoing neoadjuvant or adjuvant chemotherapy.

US Trial Phase 3

Study Type

Interventional

Study Design

Treatment, Parallel Assignment, Open Label, Randomized, Safety/Efficacy Study

Official Title

Scalp Cooling for Alopecia Prevention (SCALP)

This study is ongoing, but not recruiting participants.

Paxman treatment

Further study details as provided by Baylor Breast Care Center

Primary Outcome Measure:

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, (less than 50% of hair loss and the use of a wig of cover) 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 Pre-specified 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 System. 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 analysed suing descriptive methods with median and inter quartile rang to assess the effect of treatment group and alopecia status of functioning, quality of life and depression.

Estimate Enrolment: 235

Study Start Date: 2013

Estimated Primary Completion Date: December 2016

Estimated Study Completion Date: December 2018

US Trial Assigned Interventions

Cooling the scalp during chemotherapy may help reduce the chances of losing hair during treatment. The investigators are hoping that using the Paxman Scalp Cooling System may stop patients who are undergoing chemotherapy from losing their hair.



Eligibility

Ages eligible for study: 18 years and older

Genders eligible for study: female

Accepts healthy volunteers: no

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.
  • Concurrent trastuzumab 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.

Exclusion Criteria:

  • Stage 3 or 4 breast cancer or any other concurrent malignancy including haematological 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 urticarial.
  • Subjects who are scheduled for bone marrow ablation chemotherapy.
  • Subjects received chemotherapy with concurrent anthracycline and taxane (AT or TAC).
  • Male gender.


Contacts

Please find all contact details including name, telephone number and email address below.

Kristen Otte 713-798-8874 Kristen.Otte@bcm.edu

Claudette Foreman 713-798-7315 caforema@bcm.edu



Locations

United States, New Jersey

Hematology & Oncology Associates of Northern New Jersey - RECRUITING
Morristown, New Jersey, United States, 07962
Contact: Michelle Mackenzie, 973-538-3593 Ext. 2338, mmackenzie@hoannj.com
Contact: Karen Fritsch, 973-538-3593, kfritsch@hoannj.com
Principal Investigator: Steven Papish, MD

United States, Ohio

Cleveland Clinic - RECRUITING
Cleveland, Ohio, United States, 44195
Contact: Justina L Vigluicci, 216-444-9629, vigluij@ccf.org
Contact: Clarissa A Alabise, 216-444-9840, alabisc@ccf.org
Principal Investigator: Jame Abraham, MD

United States, Texas

Texas Oncology-Baylor Charles A. Sammons Cancer Center - RECRUITING
Dallas, Texas, United States, 75246
Contact: Sue Silva, 214-370-1087, lori.andrews@usoncology.com
Contact: Francis Collins, (214) 370-1000, francis.collins@usoncology.com
Principal Investigator: Cynthia Osborne, MD

Texas Oncology - Medical City Dallas - RECRUITING
Dallas, Texas, United States, 75230
Contact: Karen Holck, 972-566-4291, sheila.powell@usoncology.com
Contact: Sheila Powell, 972-566-4291, karen.holck@usoncology.com
Principal Investigator: Michael A Savin, MD

Lester and Sue Smith Breast Center at Baylor College of Medicine - RECRUITING
Houston, Texas, United States, 77030
Contact: Kristen Otte, BS 713-798-1999, Kristen.Otte@bcm.edu
Contact: Brenda Reusser, BA 713-798-1929, breusser@bcm.edu
Sub-Investigator: Polly Niravath, MD
Sub-Investigator: Mothaffar Rimawi, MD
Sub-Investigator: Kent Osborne, MD
Sub-Investigator: Mari Rude, NP
Sub-Investigator: Sao Jiralerspong, MD

USOncology / Texas Oncology-Memorial City - RECRUITING
Houston, Texas, United States, 77024
Contact: Hina Nazir, 713-467-1722, hina.nazir@usoncology.com
Contact: Rowena Martinez, 713-467-1722, rowena.martinez@usoncology.com
Principal Investigator: Frankie Holmes, MD

Investigators
Principal Investigator: Julie Nangia, M.D. – Baylor College of Medicine



More information

Responsible Party: Baylor Breast Care Center

Study ID Numbers: H: 33692 SCALP

Health Authority: United States: Food and Drug Administration

The Paxman Scalp Cooling System is under clinical investigation in the USA and has yet to be approved by the US FDA. For the USA, this material should be considered informational only and does not constitute an offer to sell in any jurisdiction in which this product is not yet permitted to be sold.

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