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Scalp Cooling for Hair Loss in Breast Cancer

N/A

Recruiting

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.

Must not have

History or current diagnosis of any of the following: Cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia.

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 (doxorubicin and cyclophosphamide followed by paclitaxel (AC/T), epirubicin, cyclophosphamide, and docetaxel or paclitaxel (EC/T), docetaxel (Taxotere), doxorubicin hydrochloride (Adriamycin), and cyclophosphamide (TAC), etc.)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have or had cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia.

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I plan to use a chemotherapy regimen not listed in the trial's specified treatments.

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I have an autoimmune condition that causes hair loss.

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I have had whole brain radiation treatment.

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I am currently using hair growth products like Nutrafol or minoxidil.

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I have long-term hair loss from past chemotherapy.

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I do not have any other life-threatening cancer.

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My thyroid condition is not well-managed.

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I am sensitive to cold.

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I have a blood cancer along with my current cancer.

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I do not have a serious illness or infection that could stop me from completing the treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 7 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of participants with Grade 2 or lower hair loss

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 15Eligibility criteria met