Health TrialsbyHealthPanel

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

ConditionsAlopeciaChemotherapy-induced AlopeciaHair LossBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21+
SponsorCooler Heads Care Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients ≥ 21 years of age

Documented diagnosis of breast cancer, stage I, II, or III

A planned taxane-containing CT regimen in the adjuvant or neoadjuvant setting with curative intent

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

Disqualifiers

Patients with female pattern baldness resembling picture I-3 or higher on the Savin scale

Autoimmune disease affecting hair; e.g. alopecia areata, systemic lupus with associated hair loss, others

A history of whole brain radiation

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.)

Trial design

Design model

Single group

Treatments tested in this trial

  • AMMA Portalbe Scalp Cooling System

    Device

    AMMA Portalbe Scalp Cooling System AMMA is indicated for use in chemotherapy infusion centers, during transit from the infusion center andat home and is intended for use by patients who are undergoing chemotherapy treatment and who want to reduce the likelihood of chemotherapy-induced alopecia.

Treatment groups

99 Participants
are divided into 1 treatment group
Group A: All patients will use AMMAExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Hair Loss

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

Time frame
3 Weeks

Secondary outcomes

1

Device-related adverse events

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.

Time frame
3 Weeks
2

Scalp changes

Occurrence of scalp changes in patients during and after use of the AMMA PSCS.

Time frame
3 Weeks
3

Patient symptoms

Patient symptoms reported during use of the AMMA PSCS as recorded by a symptom survey following each infusion session.

Time frame
3 Weeks
4

Subject's tolerability

Subject's tolerability of AMMA PSCS treatment demonstrated by responses to questions related to tolerability.

Time frame
3 Weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cooler Heads Care Inc.

Lead sponsor

Source ClinicalTrials.gov
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