Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III, Breast - Female, Chemotherapy Induced Alopecia
Conditions
Brief 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.
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.
Interventions
DEVICEScalp 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.
Sponsors
George Washington University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success in hair preservation after at least four cycles of chemotherapy | 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
| Measure | Time frame | Description |
|---|---|---|
| To estimate participant reported comfort of using Digniticap | 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: 1. Very Comfortable 2. Reasonably Comfortable 3. Comfortable 4. Uncomfortable 5. Very Uncomfortable |
| Evaluate quality of life (QOL) during study treatment phase- HADS | 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). |
| Evaluate quality of life (QOL) during study treatment phase- BIS | 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). 1\. 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. |
Countries
United States
Outcome results
None listed