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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
George Washington-Medical Faculty Associates
Washington D.C., District of Columbia, United States
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.
Time frame: From enrollment to the end of study (2 years)
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: 1. Very Comfortable 2. Reasonably Comfortable 3. Comfortable 4. Uncomfortable 5. Very Uncomfortable
Time frame: 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).
Time frame: 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.
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Time frame: From enrollment to the end of study (2 years)