Chemotherapy Induced Alopecia, Chemotherapy Side Effects
Conditions
Keywords
Chemotherapy Induced Alopecia, Chemotherapy Alopecia
Brief summary
Clinical Study of DA-007 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-007), 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-007 can reduce scalp blood perfusion and thus reduce hair loss due to chemotherapy.
Interventions
DRUGDA-007
Topical α1 agonist combination of Phenylephrine + Tyramine + Synephrine
DRUGPlacebo
Topical placebo solution
Sponsors
Daniel Alain, Inc.
Follea International Limited
Applied Biology, Inc.
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
Italy
Contacts
Primary ContactAndy Goren, MD
Outcome results
None listed