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Active, Not Recruiting

NCT Number: NCT07201389

CARE (Chemotherapy Alopecia REduction)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Breast Cancer Breast - Female Breast Cancer Stage I Breast Cancer Stage II Breast Cancer Stage III Breast Diseases Breast Neoplasms Chemotherapy Induced Alopecia Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

George Washington-Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Scalp Cooling by DigniCap

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.

Primary outcomes

  1. Success in hair preservation after at least four cycles of chemotherapy

    Time frame: From enrollment to the end of study (2 years)

    Success is defined as CTCAE v5.0 alopecia grade 0 (no hair loss) or grade 1 (<50% hair loss not requiring a wig). Failure is defined as CTCAE v5.0 grade 2 (≥50% hair loss, requiring use of a wig) or higher.

Secondary outcomes

  1. To estimate participant reported comfort of using Digniticap

    Time frame: From enrollment to the end of study (2 years)

    Participants will be asked if they find the procedure acceptable or unacceptable based on comfort scale used in Massey study (2004). The scale range:

    Question for participant: How comfortable were you in general throughout the scalp cooling period?

    Scale:

    • Very Comfortable
    • Reasonably Comfortable
    • Comfortable
    • Uncomfortable
    • Very Uncomfortable

  2. Evaluate quality of life (QOL) during study treatment phase- HADS

    Time frame: From enrollment to the end of study (2 years)

    QOL will be assessed by the HADS (anxiety summary and depression summary). It will be administered at baseline, after 4 cycles (except if someone is on weekly regimen, then the assessments will be done every 2 weeks x 4 times) and then after completion of chemotherapy (if the subject is receiving more than 4 cycles).

    1.The HADS will be used to assess anxiety and depression. It includes 7 questions to assess anxiety and 7 to assess depression. The summary scores (sum of the 7 question items) for anxiety and depression range from 0 to 21: scores of 0 to 7 are considered normal, 8 to 10 are considered borderline abnormal (borderline case), and 11 to 21 are considered abnormal (case).

  3. Evaluate quality of life (QOL) during study treatment phase- BIS

    Time frame: From enrollment to the end of study (2 years)

    QOL will be assessed by the BIS (body image scale appendix included protocol). It will be administered at baseline, after 4 cycles (except if someone is on weekly regimen, then the assessments will be done every 2 weeks x 4 times) and then after completion of chemotherapy (if the subject is receiving more than 4 cycles).

    • The BIS summary score will be the sum of the first 9 (of 10) items in the BIS. The summary score ranges from 0 to 27; a score of 0 indicates no symptoms or distress, and a higher score indicates increasing symptoms or distress.

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Registry information

Official study title

A Study to Investigate DigniCap Scalp Cooling on Black Patients for Prevention of Chemotherapy-induced Alopecia.

Acronym: CARE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 1, 2025
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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