Chemotherapy Induced Alopecia, Chemotherapy Side Effects
Conditions
Keywords
Chemotherapy Induced Alopecia, Chemotherapy Alopecia
Brief summary
Clinical Study of DA-020 as a Treatment for Chemotherapy Induced Alopecia
Detailed description
Chemotherapy induced alopecia (CIA) is a common adverse event of oncological treatment. The significant psychological burden of CIA, particularly in women, leads some (\ 8%) to reject life saving therapeutic regimens. Several studies have demonstrated the effectiveness of scalp vasoconstriction as a prophylactic treatment for CIA. Recently, US Food and Drug Administration (FDA) approved a scalp-cooling device as a prophylactic treatment for CIA. Scalp cooling results in reduced local blood perfusion and consequently reduced chemotherapeutic agents reaching the hair follicle niche; however, scalp cooling requires prolongation of the time required to attend the chemotherapy unit (\>2 hrs) as well as common adverse events including intolerance to cold. A previous study demonstrated that the α1 agonist, phenylephrine hydrochloride, applied topically can penetrate the scalp and bind α1 receptors. As such, a topically applied α1 agonist would reduce scalp blood perfusion. A novel formula (DA-020), containing an α1 agonist, that can also penetrate the scalp and bind α1 receptors. The aim of the study is to test the hypothesis that DA-020 can reduce scalp blood perfusion and thus reduce hair loss due to chemotherapy.
Interventions
DRUGDA-020
7mL application of DA-020 (Topical Oxymetazoline)
DRUGPlacebo
Topical placebo solution
DRUGDA-020 and Hyperforin
7mL application of DA-020 (Topical Oxymetazoline) and Hyperforin (1.5%)
Sponsors
Applied Biology, Inc.
Daniel Alain, Inc.
Follea International Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with stage I or stage II breast cancer * Scheduled but not begun, at least 4 cycles of taxane and/or anthracycline-based chemotherapy. * Ages 18-65 * Able to give informed consent
Exclusion criteria
* Resting blood pressure outside the range of 105-140/ 55-99 * Uncontrolled or severe hypertension * Female pattern hair loss or hair loss disorder * Folliculitis * Scalp psoriasis * Seborrheic dermatitis * Inflammatory scalp conditions such as lichen planopillaris * Subjects wearing wigs prior to chemotherapy * Use of MAO inhibitors * Unable to provide consent or make allotted clinical visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevention of Hair Loss (Common Terminology Criteria for Adverse Events V5.0) | Week [0,12] | Amount of hair loss during chemotherapy treatment measured by the Common Terminology Criteria for Adverse Events (CTCAE) V5.0. The Common Terminology Criteria for Adverse Events is a common terminology developed by the National Cancer Institute to describe and grade adverse events related to cancer therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hair Re-Growth Post Treatment (Common Terminology Criteria for Adverse Events V5.0) | Week [12, 24] | Amount of hair re-growth post chemotherapy treatment measured by the Common Terminology Criteria for Adverse Events (CTCAE) V5.0. The Common Terminology Criteria for Adverse Events is a common terminology developed by the National Cancer Institute to describe and grade adverse events related to cancer therapy. |
Countries
Brazil, Italy
Contacts
CONTACTAndy Goren, MD
STUDY_DIRECTORAndy Goren, MD
University of Rome G. Marconi
Outcome results
None listed