CARE (Chemotherapy Alopecia REduction)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-24

Study Completion Date

2027-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this research study is to determine if the DigniCap Scalp Cooling System can help prevent chemotherapy-induced hair loss in Black patients.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy and Safety of Dignicap System for Preventing Chemotherapy Induced Alopecia

NCT01831024

Chemotherapy Adjuvant Breast Cancer

UNKNOWN NA

Efficacy and Safety of DIGNICAP™ System

NCT03712696

Breast Cancer Chemotherapy-induced Alopecia

COMPLETED NA

Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color

NCT05213936

Alopecia

RECRUITING NA

Efficacy of Paxman Scalp Cooling to Prevent Chemo Induced Alopecia in Black Patients With Breast or GYN Cancers

NCT04626895

Breast Cancer Ovarian Cancer Gynecologic Neoplasm +1 more

COMPLETED NA

Penguin Cold Caps in the Prevention of Hair Loss in Breast Cancer Patients

NCT03289364

Breast Cancer

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The purpose of this study is to assess whether the DigniCap Scalp Cooling System can help prevent chemotherapy-induced hair loss in Black patients undergoing treatment for breast cancer. The primary objective of this study is to provide a preliminary assessment of the efficacy of the DigniCap Scalp Cooling in Black patients as prevention for chemotherapy induced alopecia.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer Breast - Female Breast Cancer Stage I Breast Cancer Stage II Breast Cancer Stage III Chemotherapy Induced Alopecia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Scalp Cooling Arm

DigniCap Scalp Cooling will be applied to all participants undergoing chemotherapy

Group Type EXPERIMENTAL

Scalp Cooling by DigniCap

Intervention Type DEVICE

Scalp cooling with the DigniCap Delta will occur with each chemotherapy dose. The cooling wrap is primed, fitted, and checked for proper contact before a standardized pre-cool phase of 20-30 minutes. Cooling continues during chemotherapy, followed by a post-cool phase of 90-180 minutes based on regimen. The system circulates temperature-controlled coolant through channels in the wrap, with sensors monitoring flow and scalp temperature; a safety sensor ensures scalp temperature never falls below 32°F (0°C). Alerts notify staff of low flow or temperature issues. After cooling, the cap is loosened for 5 minutes to warm before removal, and subjects are given 5 minutes to acclimate before standing.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Scalp Cooling by DigniCap

Scalp cooling with the DigniCap Delta will occur with each chemotherapy dose. The cooling wrap is primed, fitted, and checked for proper contact before a standardized pre-cool phase of 20-30 minutes. Cooling continues during chemotherapy, followed by a post-cool phase of 90-180 minutes based on regimen. The system circulates temperature-controlled coolant through channels in the wrap, with sensors monitoring flow and scalp temperature; a safety sensor ensures scalp temperature never falls below 32°F (0°C). Alerts notify staff of low flow or temperature issues. After cooling, the cap is loosened for 5 minutes to warm before removal, and subjects are given 5 minutes to acclimate before standing.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnosed with early stage breast cancer (stage I-III)
* Self-identify as Black
* Planned therapy with taxane and/or anthracycline-based chemotherapy (at least 4 cycles must be planned)

-≥ 21 years of age
* Able to give informed consent

Exclusion Criteria

* Female pattern hair loss or hair loss disorder
* Scalp folliculitis
* Scalp psoriasis Scalp seborrheic dermatitis
* Inflammatory scalp conditions such as lichen planopillaris or alopecia areata
* Subjects wearing wigs or subjects who shave their hair prior to chemotherapy
* Unable to provide consent or make allotted clinical visits
* Subjects with cold agglutinin disease or cold urticaria
* Unwilling to remove hair extensions during treatment phase which can interfere with study assessments
* History or whole brain irradiation
* History of prior systemic chemotherapy

Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No