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Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss

A Post-market Multi-center Prospective Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss in Women Receiving Specific Chemotherapy Regimens for Breast Cancer Stages I-III.

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
21 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "AMMA is designed to be used by patients in the chemotherapy infusion center, during transport from the infusion center to home, and after arrival at home."
  • "Patients will participate in training in AMMA use and will be asked to bring the device to the chemotherapy infusion center for use during each chemotherapy treatment visit."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether AMMA, a portable scalp cooling system, can prevent hair loss during chemotherapy for women with early-stage breast cancer. It also checks safety, comfort, use as directed, quality of life, and satisfaction with keeping hair.

The purpose of this prospective study is to assess the ability of AMMA to prevent hair loss in women receiving chemotherapy (CT) for early-stage breast cancer. Additionally, the purpose is also to assess the safety, tolerability and compliance, quality of life, and satisfaction with hair preservation after CT treatment.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women age 21 or older with confirmed stage I, II, or III breast cancer.
  • Plan to get chemotherapy with a taxane drug before or after surgery, with the goal of curing the cancer.
  • Other drugs may include trastuzumab, pertuzumab, cyclophosphamide, or carboplatin.
  • Plan to finish the current chemotherapy treatment within six months.
  • If past chemotherapy caused hair loss, it ended at least two years ago and hair has fully grown back.
  • Have a score of at least 80 on the Karnofsky scale, meaning you can do normal activities with some effort.
  • Willing and able to sign a form agreeing to join the study.
  • Willing and able to complete all required study steps.

Who can't join

  • Female-pattern hair thinning rated I-3 or higher on the study’s Savin scale; an immune system disease causing hair loss; or lasting hair loss rated grade 2 or higher after past chemotherapy.
  • Past radiation to the whole brain; past or current use of hair-growth products; or exposure to other drugs, devices, or procedures that may cause hair loss.
  • Chemotherapy without paclitaxel or docetaxel, or with an anthracycline drug. Hormone treatment during chemotherapy is also not allowed, but is allowed afterward.
  • A serious infection or illness that could prevent completing treatment and follow-up, another life-threatening cancer, or a current blood cancer.
  • Sensitivity to cold, or a past or current cold-related blood condition called cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia.
  • An overactive or underactive thyroid that is untreated or poorly controlled.
  • Taking part in another clinical study or receiving another experimental treatment.
  • Any other reason the study doctor thinks you are not a good fit for the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Female patients ≥ 21 years of age 2. Documented diagnosis of breast cancer, stage I, II, or III 3. A planned taxane-containing CT regimen in the adjuvant or neoadjuvant setting with curative intent 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. Plan to complete the current CT regimen within six months 6. At least two years out from the last CT causing hair loss with complete recovery of hair 7. Karnofsky17 performance status 80% or greater 8. Willing and able to sign informed consent for this study 9. Willing and able to complete all required study procedures Exclusion Criteria: 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 (AC/T, EC/T, TAC, etc.) 5. Hormone therapy concurrent with CT. Hormone therapy after CT is permitted 6. Current and/or prior 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 grade 2 (or higher) alopecia 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. Participation in any other clinical investigation 16. Concurrent treatment with any investigational agent 17. Any reason the investigator does not believe the patient is a good candidate for the study

Study sites (2)

AZ

IL