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Portable Scalp Cooling System (PSCS) for Alopecia

N/A
Waitlist Available
Led By Hope Rugo, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >=21 years
A planned taxane-containing chemotherapy (CT) regimen in the adjuvant or neoadjuvant setting with curative intent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 months
Awards & highlights

Study Summary

This trial aims to determine if AMMA can help prevent hair loss in women with early-stage breast cancer who are undergoing chemotherapy.

Who is the study for?
This trial is for women with early-stage breast cancer who are undergoing chemotherapy and wish to prevent hair loss. Specific eligibility details aren't provided, but typically participants must meet certain health standards.Check my eligibility
What is being tested?
The study is testing the effectiveness of the Amma Portable Scalp Cooling System (PSCS) in preventing hair loss during chemotherapy. Participants will also fill out questionnaires about their experience.See study design
What are the potential side effects?
While specific side effects of PSCS are not listed, scalp cooling can sometimes cause headaches, scalp pain, or discomfort from the cold.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 21 years old or older.
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I am scheduled for a chemotherapy that includes taxane to try to cure my cancer.
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I am fully active or can carry out light work.
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My breast cancer is confirmed and is at stage I, II, or III.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of participants with Grade 2 or lower hair loss
Secondary outcome measures
Change in scores on the EORTC- QLQ-BR23
Change in total score on the Body Image Scale (BIS)
Proportion of participants assessment of hair loss as <50%
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Portable Scalp Cooling System (PSCS)Experimental Treatment2 Interventions
Participants will participate in training in AMMA use and will be asked to bring the device for use during each non-investigational, chemotherapy treatment visit. The device will be used for 30 minutes prior to the start of chemotherapy, during chemotherapy, and for at least 2.5 hours after chemotherapy. Scalp photos will be obtained at baseline and 3 weeks after the last chemotherapy treatment. Questionnaires will be given throughout the study and 3 weeks after the last after the last chemotherapy treatment.

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,503 Previous Clinical Trials
15,236,615 Total Patients Enrolled
2 Trials studying Alopecia
28 Patients Enrolled for Alopecia
Cooler Heads Care Inc.OTHER_GOV
2 Previous Clinical Trials
99 Total Patients Enrolled
2 Trials studying Alopecia
99 Patients Enrolled for Alopecia
Hope Rugo, MDPrincipal InvestigatorUniversity of California, San Francisco
4 Previous Clinical Trials
906 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for participants currently open in this clinical trial?

"According to the information available on clinicaltrials.gov, this specific trial is not currently seeking participants. Although it was initially posted on February 1st, 2024 and recently updated on January 10th, 2024, enrollment has already concluded. However, it's worth noting that there are presently 2692 other studies actively recruiting participants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Portable Scalp Cooling System (PSCS) to Prevent Hair Loss for Breast Cancer Patients (Cooler Heads)
2024. "Portable Scalp Cooling System (PSCS) to Prevent Hair Loss for Breast Cancer Patients (Cooler Heads)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06215469.
All > Androgenetic Alopecia > Alopecia Areata
~27 spots leftby Aug 2025
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