Summary

Eligibility
for people ages 21 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
completion around
Principal Investigator
by Hope Rugo, MD
Headshot of Hope Rugo
Hope Rugo

Description

Summary

The purpose of this post-market, prospective study is to assess the ability of AMMA to prevent hair loss in women receiving chemotherapy (CT) for early-stage breast cancer.

Official Title

Amma™ Portable Scalp Cooling System (PSCS) Study: A Post-market Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss in Women Receiving Specific Chemotherapy Regimens for Early-stage Breast Cancer

Details

PRIMARY OBJECTIVE:

  1. To evaluate hair loss as assessed by the investigator at 3 weeks (±1 week) after the completion of the last chemotherapy (CT) treatment/infusion visit using the Common Terminology Criteria for Adverse Events (CTCAE) by comparing post-treatment photographs to pre-treatment photographs.

SECONDARY OBJECTIVES:

  1. To assess safety of the Amma PSCS based on the occurrence of device-related adverse events, occurrence of scalp changes determined by physical examination, and patient symptoms with use of the PSCS.

II. To evaluate hair loss as measured by the patient at 3 weeks (±1 week) after the completion of the last treatment/infusion visit using the Common Terminology Criteria for Adverse Events (CTCAE v5.0 or above) by comparing post-treatment photographs to baseline photographs.

III. To assess tolerability/compliance with use of the PSCS. IV. To assess patient quality of life and satisfaction with hair preservation after Amma PSCS usage using the Body Image Scale (BIS) and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) for Breast Cancer (EORTC-QLQ-BR23) questionnaire.

OUTLINE:

Participants will use the AMMA PSCS while receiving non-investigational, chemotherapy treatments. Participants may continue device usage through their last cycle of chemotherapy (approximately 6 months) and will be followed for 30 days after the last device usage date, until removal from study, or until death, whichever occurs first.

Keywords

Breast Cancer, Early-stage Breast Cancer, Hair Loss, Alopecia, Chemotherapy-induced Alopecia, Hair Loss Prevention, Amma, Breast Neoplasms, Alopecia Areata, Amma Portable Scalp Cooling System (PSCS), Portable Scalp Cooling System (PSCS)

Eligibility

You can join if…

Open to people ages 21 years and up

  1. Participants must have histologically or cytologically confirmed breast cancer, stage I, II, or III.
  2. A planned taxane-containing chemotherapy (CT) regimen in the adjuvant or neoadjuvant setting with curative intent.
  3. Plan to complete the current CT regimen within six months.
  4. Concomitant agents may include trastuzumab, pertuzumab, or other CT agents such as cyclophosphamide, or carboplatin. Note: Targeted and/or hormonal therapies intended for use after completion of the taxane-containing CT regimen will not be considered part of the study treatment period, and the Amma PSCS will not be used during the post-CT targeted and/or hormonal therapy period.
  5. At least two years out from the last CT causing hair loss with complete recovery of hair.
  6. Age >=21 years
  7. Eastern Cooperative Oncology Group (ECOG) performance status of <=1.
  8. Ability to understand and the willingness to sign a written informed consent document.

You CAN'T join if...

  1. Patients with female pattern baldness resembling picture I-3 or higher on the Savin scale.
  2. Autoimmune disease affecting hair, e.g., alopecia areata, systemic lupus with associated hair loss, others.
  3. A history of whole brain radiation.
  4. Plans to use a CT regimen other than those specified in the inclusion criteria; specifically, a regimen not including paclitaxel or docetaxel or a regimen including an anthracycline (doxorubicin and cyclophosphamide followed by paclitaxel (AC/T), epirubicin, cyclophosphamide, and docetaxel or paclitaxel (EC/T), docetaxel (Taxotere), doxorubicin hydrochloride (Adriamycin), and cyclophosphamide (TAC), etc.)
  5. Hormone therapy after CT is permitted and ovarian function suppression during chemotherapy is permitted.
  6. Concurrent use of hair growth products, such as Nutrafol, minoxidil, and Keranique.
  7. A serious concurrent infection or medical illness which would jeopardize the ability of the patient to complete the planned therapy and follow-up.
  8. History of persistent alopecia (any grade) induced by prior chemotherapeutic regimens.
  9. History of and/or current exposure to other agents, drugs, device, or procedure that may cause hair loss.

    10. Cold sensitivity. 11. Intercurrent life-threatening malignancy. 12. Evidence of untreated or poorly controlled hyperthyroidism or hypothyroidism. 13. History or current diagnosis of any of the following: Cold agglutinin disease,

    cryoglobulinemia, or cryofibrinogenemia.

    14. Concurrent hematologic malignancy. 15. Concurrent treatment with any investigational agent. 16. Any reason the investigator does not believe the patient is a good candidate for the

    study.

    17. Has received systemic cytotoxic therapies within 3 weeks of first dose. Concomitant

    administration of Luteinizing hormone-releasing hormone (LHRH) analogues is allowed.

Location

  • UCSF accepting new patients
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Hope Rugo, MD
    Dr. Hope Rugo is a medical oncologist and hematologist specializing in breast cancer research and treatment. A Clinical Professor of Medicine, Dr. Rugo joined the Breast Care Center in 1999 after a decade of experience at UCSF in malignant hematology and bone marrow transplantation for a variety of diseases, including breast cancer.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT06215469
Study Type
Interventional
Participants
Expecting 40 study participants
Last Updated