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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scalp Cooling Arm | Experimental | DigniCap Scalp Cooling will be applied to all participants undergoing chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of study (2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
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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:
Black women, black female
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George Washington-Medical Faculty Associates | Washington D.C. | District of Columbia | 20037 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33512741 | Background | 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. | |
| 12112485 | Background | Benjamin 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 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). | 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). 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. | From enrollment to the end of study (2 years) |
| 10614362 | Background | Pozo-Kaderman C, Kaderman RA, Toonkel R. The psychosocial aspects of breast cancer. Nurse Pract Forum. 1999 Sep;10(3):165-74. |
| D017437 |
| Skin and Connective Tissue Diseases |