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Treatment Group for Adjuvant Chemotherapy
N/A
Waitlist Available
Research Sponsored by Target Health Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Summary
The efficacy and safety of the Dignicap System to prevent chemotherapy induced alopecia will be evaluated in women with early breast cancer undergoing adjuvant or neoadjuvant chemotherapy regimens. The scalp cold cap will be applied at each chemotherapy cycle. Hair loss will be evaluated by patient self assessment of 5 standardized photographs taken prior to each chemotherapy cycle. A concurrent control group not using a cold cap will also be evaluated.
Eligible Conditions
- Breast Cancer
- Adjuvant Chemotherapy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Hair loss
Secondary study objectives
Adverse events
Hair regrowth
Quality of Life
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment GroupExperimental Treatment1 Intervention
Dignicap System
Group II: Control GroupActive Control1 Intervention
Concurrent age and chemotherapy matched control
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Who is running the clinical trial?
Target Health Inc.Lead Sponsor
6 Previous Clinical Trials
410 Total Patients Enrolled
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