Clinical trial · Interventional
CARE (Chemotherapy Alopecia REduction)
A Study to Investigate DigniCap Scalp Cooling on Black Patients for Prevention of Chemotherapy-induced Alopecia.
NCT07201389CI-TRIAL-00096051CAREactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer Stage I | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Breast Cancer Stage II | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Breast Cancer Stage III | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Breast - Female | — | UNRESOLVED | — |
| Chemotherapy Induced Alopecia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Scalp Cooling by DigniCap | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Scalp Cooling Arm
- description
- DigniCap Scalp Cooling will be applied to all participants undergoing chemotherapy
- interventionNames
- Device: Scalp Cooling by DigniCap
Primary outcomes (1)
- measure
- Success in hair preservation after at least four cycles of chemotherapy
- timeFrame
- From enrollment to the end of study (2 years)
- description
- 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 (3)
- measure
- To estimate participant reported comfort of using Digniticap
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDDilawari 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. PMID 33512741
- BACKGROUNDBenjamin 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. PMID 12112485
- BACKGROUNDPozo-Kaderman C, Kaderman RA, Toonkel R. The psychosocial aspects of breast cancer. Nurse Pract Forum. 1999 Sep;10(3):165-74. PMID 10614362