Scalp Cooling for Alopecia

Overseen By Charles E Mays, PhD, CCRP, CCRC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Charles Mays

Must be taking: Anthracyclines, Taxanes

Disqualifiers: Stage IV disease, Scalp metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This single-blind, randomized controlled trial is proposed to assess the effects of the PAXMAN Scalp Cooling System on the quality of life of breast cancer subjects receiving any treatment regimen consisting of a chemotherapy agent known to cause chemotherapy-induced alopecia (CIA). Quality of life will be measured using the Chemotherapy-Induced Alopecia Distress Scale (CADS) for cancer patients pre-and post-treatment. Simultaneously, the effect of scalp cooling on hair retention and regrowth will be determined by self-reported grading of photographic assessment using the Alopecia (Hair Loss) Pictorial Tool. Results will be correlated with presence of single nucleotide variations (SNVs) rs3820706 in the CACNB4 gene and rs1202179 in the ABCB1 gene. Participants will be blinded to genetic results until the completion of the study to prevent bias, as knowing results could influence the participants' behavior.

Are You a Good Fit for This Trial?

Inclusion Criteria

I have stage I-III breast cancer and will get anthracycline or taxane chemotherapy.

I am 18 years old or older.

I have agreed to join the study after being fully informed and giving my consent.

Exclusion Criteria

I plan to shave my head completely during chemotherapy.

I cannot use the PAXMAN Scalp Cooling System due to health reasons.

I do not have scalp sores or pain that would get worse with a cooling cap.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy Treatment

Participants receive chemotherapy treatment with or without the PAXMAN Scalp Cooling System

12 weeks

Visits on Day 1, 4 weeks, 8 weeks, and 12 weeks

Follow-up

Participants are monitored for hair retention, regrowth, and quality of life post-treatment

12 weeks

Post-treatment assessments at 4 weeks, 8 weeks, and 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Paxman Scalp Cooling System

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 1 Intervention

Receiving CIA treatment with the PAXMAN Scalp Cooling System

Group II: Control Arm Active Control 1 Intervention

No hair retention treatment

Who Is Running the Clinical Trial?

Charles Mays

Lead Sponsor

Paxman Scalp Cooling

Collaborator