Scalp Cooling for Hair Loss in Chemotherapy

(CARE Trial)

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: George Washington University

Must be taking: Taxane, Anthracycline

Disqualifiers: Hair loss disorders, Scalp conditions, Prior chemotherapy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the DigniCap Scalp Cooling System can prevent hair loss in Black patients undergoing specific chemotherapy treatments for early-stage breast cancer. Participants wear the cooling cap during chemotherapy sessions to determine its effectiveness in protecting hair. This trial suits individuals who self-identify as Black, have stage I-III breast cancer, and plan to begin chemotherapy with taxane or anthracycline drugs for at least four cycles. As an unphased trial, it offers a unique opportunity to contribute to research that may 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 DigniCap Scalp Cooling System is safe for preventing hair loss in chemotherapy patients?

Research has shown that the DigniCap Scalp Cooling System is generally safe to use. This system helps prevent hair loss during chemotherapy. Studies have found that scalp cooling effectively reduces hair loss for many patients treated for breast cancer. In one study, the DigniCap system helped 77% of patients avoid significant hair loss.

The FDA has approved the system to reduce hair loss caused by chemotherapy in women with breast cancer. However, some women still experienced hair loss despite using the cooling system and reported a lower quality of life. This indicates that while the system is safe, its effectiveness can vary.

Overall, evidence supports that the DigniCap Scalp Cooling System is well-tolerated, though individual experiences may differ. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the DigniCap Scalp Cooling System because it offers a new way to tackle hair loss during chemotherapy. Unlike traditional methods that often focus on wigs or topical treatments after hair loss has occurred, the DigniCap proactively works to prevent hair loss by cooling the scalp during chemotherapy sessions. This cooling constricts blood vessels, reducing the amount of chemotherapy drugs that reach hair follicles, thus minimizing damage. This approach not only aims to preserve the patient's natural hair but also enhances emotional well-being during a challenging time.

What evidence suggests that the DigniCap Scalp Cooling System is effective for preventing chemotherapy-induced hair loss in Black patients?

Research has shown that the DigniCap Scalp Cooling System, used by participants in this trial, can help reduce hair loss for people undergoing chemotherapy. One study prevented significant hair loss in 43% of breast cancer patients receiving chemotherapy. Another study found that 52% of patients experienced less hair loss with scalp cooling. In a different study, 65% of patients had little to no visible hair loss after using the cooling system. These results suggest that scalp cooling can effectively reduce hair loss during chemotherapy. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for Black patients with breast cancer who are undergoing chemotherapy and wish to prevent hair loss. Specific eligibility details are not provided, but typically participants must meet certain health standards and not have conditions that would exclude them from safely using the scalp cooling system.

Inclusion Criteria

Self-identify as Black

Able to give informed consent

My breast cancer is in an early stage (I-III).

Exclusion Criteria

Subjects wearing wigs or subjects who shave their hair prior to chemotherapy

Subjects with cold agglutinin disease or cold urticaria

I have psoriasis on my scalp.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo chemotherapy with the DigniCap Scalp Cooling System applied to prevent hair loss

Up to 2 years

Visits aligned with chemotherapy cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DigniCap Scalp Cooling System

Trial Overview

The CARE study is testing the effectiveness of the DigniCap Scalp Cooling System in preventing hair loss among Black patients receiving chemotherapy for breast cancer.

How Is the Trial Designed?

Group I: Scalp Cooling Arm Experimental Treatment 1 Intervention

DigniCap Scalp Cooling will be applied to all participants undergoing chemotherapy

Who Is Running the Clinical Trial?

George Washington University

Lead Sponsor

Trials

263

Recruited

476,000+

Citations

1.

dignicap.com

dignicap.com/research/

Clinical Research

DigniCap was able to prevent significant hair loss in 43% of breast cancer patients receiving adjuvant chemotherapy. For more information about the DigniCap ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9600590/

Prospective Study Investigating the Efficacy and Safety of a ...

Our results confirmed the potential positive effect of the scalp cooling system in preventing alopecia, with a fairly good safety profile, in BC patients ...

3.

cms.gov

cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39573&ver=3

LCD - Scalp Cooling for the Prevention of Chemotherapy ...

Scalp cooling was effective in 52% of the cases. Alopecia was considered among the most distressing problems at all 3 moments of measurement. A trend towards ...

4.

dignicap.com

dignicap.com/research-solid-tumors/

Solid Tumors

146 (65%) patients showed a positive effect of scalp cooling with no or only mild alopecia (not visible, chemotherapy-induced alopecia grades 0 and 1) after ...

5.

facingourrisk.org

facingourrisk.org/XRAY/scalp-cooling-and-hair-loss

Scalp cooling devices prevent hair loss from chemotherapy

These studies suggest that scalp cooling may be associated with less severe chemotherapy-related hair loss in patients treated for early-stage breast cancer.

6.

dignicap.com

dignicap.com/wp-content/uploads/2019/09/Contraindications-EN.pdf

Safety Considerations

Data have shown that women who experience hair loss in spite of using scalp cooling might have worse quality of life than women who did not have scalp cooling.

7.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/reviews/DEN150010.pdf

DEN150010.pdf - accessdata.fda.gov

The DigniCap™ Scalp Cooling System is indicated to reduce the likelihood of chemotherapy - induced alopecia in women with breast cancer. LIMITATIONS. The sale, ...

8.

dignicap.com

dignicap.com/clinical-resources-delta/

Clinical Resources Delta

Scalp cooling, sometimes known as cold caps, is an effective method to greatly reduce chemotherapy-induced alopecia in cancer patients with solid tumors.

9.

annalsofoncology.org

annalsofoncology.org/article/S0923-7534(19)56757-6/fulltext

F16 - Preventing chemotherapy-induced alopecia by scalp ...

Conclusions: DigniCap® System was able to prevent significant hair loss in 77% of primary breast cancer pts who completed planned adjuvant chemotherapy.