100 Participants NeededMy employer runs this trial

Scalp Cooling for Alopecia

CE
Overseen ByCharles E Mays, PhD, CCRP, CCRC
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Charles Mays
Must be taking: Anthracyclines, Taxanes
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the PAXMAN Scalp Cooling System might help breast cancer patients undergoing chemotherapy retain their hair and improve their quality of life. The researchers aim to determine if cooling the scalp can reduce hair loss and promote regrowth. Participants will have their hair condition photographed to track changes and assess the role of genetic factors. Suitable candidates have stage I to III breast cancer and are receiving specific chemotherapy treatments known to cause hair loss. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance the quality of life for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the PAXMAN Scalp Cooling System is safe for breast cancer patients?

Research has shown that the Paxman Scalp Cooling System is generally safe for reducing hair loss caused by chemotherapy. In a study of nearly 2,000 patients, only 0.61% experienced cancer spread to the scalp over an average of about 43 months. This low rate suggests the treatment is well-tolerated.

The system effectively preserves hair during chemotherapy, with 53 out of 95 patients successfully keeping their hair. The device is FDA-cleared, indicating it has been reviewed and approved for safety for certain uses.

Overall, the Paxman Scalp Cooling System maintains a good safety record with few reported side effects.12345

Why are researchers excited about this trial?

Researchers are excited about the Paxman Scalp Cooling System because it offers a unique approach to managing chemotherapy-induced alopecia (CIA). Unlike traditional methods that mainly involve wigs or topical applications, this system works by cooling the scalp to reduce blood flow to hair follicles during chemotherapy, thereby minimizing hair loss. This non-invasive method not only aims to preserve the patient's natural hair but also enhances their quality of life by addressing the emotional and psychological impacts of hair loss during cancer treatment.

What evidence suggests that the Paxman Scalp Cooling System is effective for chemotherapy-induced alopecia?

Research has shown that the Paxman Scalp Cooling System can help reduce hair loss caused by chemotherapy in breast cancer patients. In this trial, participants in the treatment arm will use the Paxman Scalp Cooling System, while those in the control arm will not receive any hair retention treatment. One study found that 43% of patients using scalp cooling retained enough hair to avoid wearing head coverings by the end of their treatment. Another study reported that 56% of patients didn't need a head covering during their last chemotherapy session, and 53% experienced only minimal hair loss. Overall, several clinical trials have consistently shown that scalp cooling lessens hair loss.12367

Are You a Good Fit for This Trial?

This trial is for adults (18+) with stage I-III breast cancer who are about to start chemotherapy known to cause hair loss. Participants must not plan to shave their heads, and cannot join if they have scalp conditions, certain blood cancers, cold allergies, or advanced (stage IV) disease.

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.
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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

Trial Overview

The study tests the Paxman Scalp Cooling System during chemotherapy to see if it helps prevent hair loss and improves quality of life. It also looks at whether specific genetic differences affect results. Participants are randomly assigned and blinded to some information.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Treatment ArmExperimental Treatment1 Intervention
Group II: Control ArmActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Charles Mays

Lead Sponsor

Paxman Scalp Cooling

Collaborator

Citations

The Efficacy of Paxman Scalp Cooling System in Preventing ...

PSCS is an effective and well-tolerated treatment modality for preventing CIA among breast cancer patients undergoing chemotherapy.

Efficacy of paxman scalp cooling system at lower ...

43% of patients had hair preservation at the completion of the study. At 24 weeks post treatment, the average hair count and width was higher ...

Scalp Cooling Efficacy and Safety | Clinical Data

Scalp cooling efficacy for preventing chemotherapy-induced alopecia has been proven in many clinical trials for all solid tumor cancers.

Efficacy & Safety

56% of patients did not require a head covering during their final chemotherapy treatment. 53% of patients were reported to have minimal hair ...

Effectiveness of Scalp-cooling Therapy for Preventing ... - PMC

In conclusion, scalp cooling significantly reduced severe chemotherapy-induced scalp alopecia and may offer partial protection against eyebrow ...

Paxman Scalp Cooling Safety Information - US

0.61% of 1959 patient who scalp cooled showed incidence of scalp metastases over a mean time frame of 43.1 months. 0.41% of 1238 patients that didn't scalp ...

Safety and efficacy of scalp cooling system in preventing ...

From various studies, it was proven that scalp-cooling therapy was successful in almost 30–80% of patients [7,16]. The hair preservation rate in the present ...