Alopecia, Radiodermatitis
Conditions
Keywords
alopecia, hair loss, prevention, radiotherapy, head & neck cancer, radiodermatitis, radiation dermatitis, radiation-induced alopecia
Brief summary
The study will evaluate the safety of topical norepinephrine in head and neck cancer patients who are receiving treatment with intensity modulated radiotherapy (IMRT). The study will also provide information about whether topical norepinephrine can prevent or decrease the severity of the radiation-induced alopecia experienced by these patients.
Interventions
DRUGNorepinephrine
The occipital scalp zone at risk for alopecia will be identified. The norepinephrine treatment site will be randomized to receive consistent treatment of one half of the scalp risk zone. Approximately 1.6 mL of a 400 mM norepinephrine solution will be applied topically to the norepinephrine site approximately 20 minutes prior to each radiation treatment, and placebo will be applied to the contralateral side (30-35 treatments).
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
ProCertus BioPharm, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* be ≥ 18 years of age with documented pathological diagnosis of H&N (head and neck) cancer. * planned to receive H&N region IMRT treatment in which the mean dose to the dermis in the scalp risk zone (isodose plan) is estimated to be at least 20 Gy. * have a palpable nuchal prominence (external occipital protuberance) * have the ability to understand the informed consent document. * be able to comply with protocol schedule. * have a negative serum pregnancy test if a female of childbearing potential. * consent to utilize medically acceptable methods of contraception throughout the study if of childbearing potential. * be treated with IMRT alone or with concurrent platinum based chemotherapy * receive definitive treatment for oropharyngeal squamous cell carcinoma
Exclusion criteria
* with clinical or radiographic evidence of adenopathy to the high level V posterior cervical nodes, post-auricular or occipital cervical nodal stations * planned to receive H&N region treatment in which the mean dose to the dermis in the scalp risk zone (isodose plan) is estimated to exceed 50Gy * with underlying active untreated cardiac disease (e.g. arrhythmia) * receiving concurrent chemotherapy other than single agent platinum based * with generalized skin disorders that have required treatment within the past 6 months. * with connective tissue disorders * with unhealed wounds or scars in the study area * with rashes, ulcerations, or poorly healed scars in the treatment area * with a known allergy to norepinephrine * with a known clinically significant abnormal ECG (electrocardiogram) within the past 6 months. * taking MAO (monoamine oxidase) inhibitors or antidepressants of the triptyline or imipramine types * taking β-blockers * with NCI-CTCAE Version 4.0 grade 2 or higher hypertension at the time of study entry.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of daily topical application of norepinephrine to the radiation field. | Safety will be assessed during the study (6-7 weeks) and at follow-up visits approximately 2 and 4 weeks after the end of the treatment period. | The primary safety hypothesis is that there will be that there will be little or no scalp irritation associated with the application of the topical norepinephrine and that there will be no systemic effects secondary to transdermal absorption. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of daily topical application of norepinephrine to the radiation field. | Efficacy will be assessed during the study (6-7 weeks) and at follow-up visits approximately 2 and 4 weeks after the end of the treatment period | The primary efficacy hypothesis is that areas of the scalp that are treated with topical norepinephrine immediately prior to intensity modulated radiotherapy (IMRT) will have less severe alopecia than scalp sites that are not treated with topical norepinephrine and that receive only placebo. |
Countries
United States
Outcome results
None listed