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Efficacy and safety study of PAXMAN and HairRepro MEDI Alpha for Chemotherapy Induced Alopecia for breast cancer

Efficacy and safety study of PAXMAN and HairRepro MEDI Alpha for Chemotherapy Induced Alopecia for breast cancer - PAXMAN and HairRepro MEDI Alpha study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000048637
Enrollment
27
Registered
2022-08-15
Start date
2022-08-15
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer

Interventions

Apply HairRepro MEDI Alpha to the scalp and eyebrows twice a day, 4 ml per application. A scalp cooling system (PAXMAN Scalp Cooling System) is applied to the head during chemotherapy, and cooling is

Sponsors

Department of Surgery and Science, Faculty of Medicine,Academic Assembly, University of Toyama
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) Breast cancer patient 2) Patient who have been decided to receive preoperative or postoperative chemotherapy 3) ECOG PS of 0 to 2 4) Patients with sufficient preservation of major organ function 5) Age: 20 years or older 6) Category of consultation: outpatient 7) Patients who agreed to the use of Paxman at their own expense 8) Patients who have given written consent to participate in this study

Exclusion criteria

Exclusion criteria: 1) Patients with active multiple cancers 2) Patients with serious concomitant diseases (such as hepatic, renal, cardiac, hematological, or metabolic diseases) or psychiatric disorders 3) Patients who have been taking concomitantly banned drugs or study drugs within 4 weeks prior to the start of the study. 4) Patients with a history of allergy to Clozapine 5) Patients with eczema or other skin diseases on the head

Design outcomes

Primary

MeasureTime frame
Percentage of improvement in alopecia 90 days after completion of chemotherapy based on imaging evaluation Percentage of hair loss based on imaging evaluation at each observation point

Secondary

MeasureTime frame
Patient's quality of life:Chemotherapy-Induced Alopecia Distress Scale Presence of adverse events Tolerability: Percentage of patients who completed all cycles of chemotherapy while using both drugs

Countries

Japan

Contacts

Public ContactAraki Misato

University of Toyama Department of Surgery and Science Faculty of Medicine

arammi33@med.u-toyama.ac.jp076-434-7311

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026