Breast CancerCARENCT07201389
CARE (Chemotherapy Alopecia REduction)
A study testing Scalp Cooling by DigniCap in people with Breast Cancer and Breast - Female, run by George Washington University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast - Female, Breast Cancer Stage I
- What is being tested?
- Scalp Cooling by DigniCap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2025to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
George Washington-Medical Faculty Associates
Washington D.C., District of Columbia, 20037
About this study
Official title: A Study to Investigate DigniCap Scalp Cooling on Black Patients for Prevention of Chemotherapy-induced Alopecia.
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.
Read the detailed description
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
- Breast Cancer, Breast - Female, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III, Chemotherapy Induced Alopecia
- Being tested
- Scalp Cooling by DigniCap
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scalp Cooling by DigniCapDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Scalp Cooling Arm | Experimental | DigniCap Scalp Cooling will be applied to all participants undergoing chemotherapy Receives: Device: Scalp Cooling by DigniCap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success in hair preservation after at least four cycles of chemotherapy
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.
Measured: From enrollment to the end of study (2 years)
Secondary outcomes (3)
To estimate participant reported comfort of using Digniticap
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
Measured: From enrollment to the end of study (2 years)
Evaluate quality of life (QOL) during study treatment phase- HADS
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).
Measured: From enrollment to the end of study (2 years)
Evaluate quality of life (QOL) during study treatment phase- BIS
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.
Measured: From enrollment to the end of study (2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start24 Sep 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pavani Chalasani, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201389
- Sponsor's protocol ID
- CARE (Scalp Cooling Protocol)
- Acronym
- CARE
- Status last verified
- Sep 2025
- First submitted
- 24 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Dilawari A, Gallagher C, Alintah P, Chitalia A, Tiwari S, Paxman R, Adams-Campbell L, Dash C. Does Scalp Cooling Have the Same Efficacy in Black Patients Receiving Chemotherapy for Breast Cancer? Oncologist. 2021 Apr;26(4):292-e548. doi: 10.1002/onco.13690. Epub 2021 Feb 17.
PubMed 33512741Benjamin B, Ziginskas D, Harman J, Meakin T. Pulsed electrostatic fields (ETG) to reduce hair loss in women undergoing chemotherapy for breast carcinoma: a pilot study. Psychooncology. 2002 May-Jun;11(3):244-8. doi: 10.1002/pon.593.
PubMed 12112485Pozo-Kaderman C, Kaderman RA, Toonkel R. The psychosocial aspects of breast cancer. Nurse Pract Forum. 1999 Sep;10(3):165-74.
PubMed 10614362
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate DigniCap Scalp Cooling on Black Patients for Prevention of Chemotherapy-induced Alopecia.
- ClinicalTrials.gov ID
- NCT07201389
- Acronym / sponsor ID
- CARE / CARE (Scalp Cooling Protocol)
- Conditions
- Breast Cancer, Breast - Female, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III, Chemotherapy Induced Alopecia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- 24 Sep 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scalp Cooling Arm | Experimental | Device: Scalp Cooling by DigniCapDigniCap Scalp Cooling will be applied to all participants undergoing chemotherapy |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scalp Cooling by DigniCapScalp 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. | Device | Scalp Cooling Arm |
Primary outcome
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.
3 secondary outcomes
To estimate participant reported comfort of using Digniticap
Time frame: From enrollment to the end of study (2 years)
Evaluate quality of life (QOL) during study treatment phase- HADS
Time frame: From enrollment to the end of study (2 years)
Evaluate quality of life (QOL) during study treatment phase- BIS
Time frame: From enrollment to the end of study (2 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Background: PubMed 33512741Dilawari A, Gallagher C, Alintah P, Chitalia A, Tiwari S, Paxman R, Adams-Campbell L, Dash C. Does Scalp Cooling Have the Same Efficacy in Black Patients Receiving Chemotherapy for Breast Cancer? Oncologist. 2021 Apr;26(4):292-e548. doi: 10.1002/onco.13690. Epub 2021 Feb 17.
- Background: PubMed 12112485Benjamin B, Ziginskas D, Harman J, Meakin T. Pulsed electrostatic fields (ETG) to reduce hair loss in women undergoing chemotherapy for breast carcinoma: a pilot study. Psychooncology. 2002 May-Jun;11(3):244-8. doi: 10.1002/pon.593.
- Background: PubMed 10614362Pozo-Kaderman C, Kaderman RA, Toonkel R. The psychosocial aspects of breast cancer. Nurse Pract Forum. 1999 Sep;10(3):165-74.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scalp Cooling by DigniCap in people with Breast Cancer and Breast - Female, run by George Washington University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success in hair preservation after at least four cycles of chemotherapy (time frame: From enrollment to the end of study (2 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07201389, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.