Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Chemotherapy-Induced Alopecia
Conditions
Brief summary
This phase II trial compares the safety and effectiveness of topical minoxidil alone to topical minoxidil in combination with low-level red-light therapy for improving chemotherapy-induced hair loss or thinning (alopecia). Minoxidil has been approved by the Food and Drug Administration as a treatment for hair loss. It increases blood flow in the skin and may have a direct stimulatory effect on hair follicle cells, forcing them from their resting phase into their active growth phase. Low-level light therapy is regarded as a safe and medically accepted treatment for a variety of skin conditions, including acne, scars, and psoriasis. Red light wavelengths are readily absorbed into the skin and do not contain harmful ultraviolet light. When absorbed into the skin, these wavelengths stimulate fibroblasts, which are connective tissue cells that make and secrete collagen proteins. Low-level red-light therapy may improve hair loss by stimulating hair follicles. Combining minoxidil with low-level red-light therapy may be safe and more effective at improving chemotherapy-induced alopecia than minoxidil alone.
Detailed description
PRIMARY OBJECTIVE: I. To determine the improvement in hair density as determined by the Dean scale score in patients with chemotherapy-induced alopecia following treatment with low-level light therapy (LLLT) and topical minoxidil versus topical minoxidil alone. SECONDARY OBJECTIVES: I. To determine the improvement in hair density and hair diameter as determined by trichoscopic evaluation in patients with chemotherapy-induced alopecia following treatment with LLLT and topical minoxidil versus topical minoxidil alone. II. To determine the change in the quality-of-life Chemotherapy Alopecia Distress Scale (CADS) questionnaire score in patients with chemotherapy-induced alopecia following treatment with LLLT and topical minoxidil versus topical minoxidil alone. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive minoxidil topically to the scalp daily for 6 months in the absence of unacceptable toxicity. ARM II: Patients receive minoxidil topically to the scalp daily and undergo low-level red-light therapy with the Revian RED LED-light cap over 10 minutes daily for 6 months in the absence of unacceptable toxicity. After completion of study intervention, patients are followed up at 12 months.
Interventions
OTHERElectronic Health Record Review
Ancillary studies
DRUGMinoxidil
Given topically
DEVICERevian RED LED-light cap
Undergo low-level red-light therapy with Revian RED LED-light cap
OTHERSurvey Administration
Ancillary studies
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Masking description
Clinical treatment response will be scored by a blinded investigator.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients will be Ohio State University patients \> 18 years old * Patients will have a diagnosis of breast cancer, stages I-IV * Patients will have been treated with a chemotherapy regimen containing either an anthracycline or taxane * Patients will have a loss of at least 50% of the hair on the scalp by the final chemotherapy infusion * Patients will NOT be pregnant or nursing women * Patients will NOT have a history of scarring/cicatricial alopecia or alopecia areata * Patients will NOT have a known sensitivity to minoxidil * Patients will NOT have ongoing treatment with an antibody-drug conjugate or immunotherapy * NOTE: There is no
Exclusion criteria
for utilization of scalp cooling
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dean scale score | After 6 months of intervention | The Dean scale measures hair loss along a 4-grade scale. Grade 1 = \<25% hair loss. Grade 2= 25-50% hair loss. Grade 3=50-75% hair loss. Grade 4 = \>75% hair loss. Success will be defined as Dean scale score of 1 or 0. This will be based on clinical photographs taken at the initial and 6-month visits and scored by two board-certified dermatologists. Will construct two-sided 95% confidence intervals for improvement from baseline and differences between randomized groups, including the proportion of patients with a Dean score of 1 or 0 at 6 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Dean scale score | From baseline to 2, 4, and 12 months | The Dean scale measures hair loss along a 4-grade scale. Grade 1 = \<25% hair loss. Grade 2= 25-50% hair loss. Grade 3=50-75% hair loss. Grade 4 = \>75% hair loss.Will be reported by treatment group using summary statistics (mean and standard deviation, median and quartiles, or count and percentage, as appropriate). Will construct two-sided 95% confidence intervals for improvement from baseline and differences between randomized groups. |
| Change in trichoscopic hair density | From baseline to 2, 4, 6, and 12 months | Measures of hair density will be taken via trichoscopic photography by use of the HairMetrix device. Density measurements will be reported by treatment group using summary statistics (mean and standard deviation, median and quartiles, or count and percentage, as appropriate). Will construct two-sided 95% confidence intervals for improvement from baseline and differences between randomized groups. |
| Change in Chemotherapy Alopecia Distress Scale (CADS) | From baseline to 2, 4, 6, and 12 months | CADS is a 17-item tool that measures hair loss distress. Each question uses a 4-point likert scale (0-3), and total scores range from 0-51 with higher scores indicating greater hair loss distress. Longitudinal mixed effects linear and generalized linear or logistic models will be used with improvement from baseline as the outcome at 2, 4, 6, and 12 months. Randomization group, time point, and their interaction will be used as fixed effects, and a subject random effect will be used to account for within-subject correlation of outcomes. For CADS, baseline score will also be included as a fixed effect. TWill be reported by treatment group using summary statistics (mean and standard deviation, median and quartiles, or count and percentage, as appropriate). Will construct two-sided 95% confidence intervals for improvement from baseline and differences between randomized groups. |
| Change in patient reported outcomes (hair loss survey) | From baseline to 2, 4, 6, and 12 months | Participants will be asked four questions about symptoms related to hair loss over the last week. Each question is scored on a scale with possible answers ranging from 0 (not present) to 10 (as bad as you can imagine). Will be reported by treatment group using summary statistics (mean and standard deviation, median and quartiles, or count and percentage, as appropriate). Will construct two-sided 95% confidence intervals for improvement from baseline and differences between randomized groups. |
| Change in patient reported outcomes (feelings survey) | From baseline to 2, 4, 6, and 12 months | Participants will be asked four questions about their general feelings over the last week. Each question is scored on a scale with possible answers ranging from 0 (as bad as it can be) to 10 (as good as it can be). Will be reported by treatment group using summary statistics (mean and standard deviation, median and quartiles, or count and percentage, as appropriate). Will construct two-sided 95% confidence intervals for improvement from baseline and differences between randomized groups. |
| Differences in patient satisfaction (feasibility) | At 2, 4, and 6 months | Differences in patient satisfaction will be used to determine differences in feasibility between the two treatment arms. Participants will be asked five questions about their satisfaction with hair changes and study treatment over the last two months. Each question will be scored on a scale ranging from 0 (not satisfied at all) to 10 (as satisfied as I can be). Will be reported by treatment group using summary statistics (mean and standard deviation, median and quartiles, or count and percentage, as appropriate). |
| Compliance | At 2, 4, and 6 months | Differences in medication administration logs will be used to determine differences in compliance between the two treatment arms. For the topical minoxidil group, the proportions of days medication was applied will be reported. For the low-level red-light therapy + minoxidil group, the proportions of days minoxidil was applied as well as the proportions of weeks that the low-level red-light therapy was used will be reported. Will be reported by treatment group using summary statistics (mean and standard deviation, median and quartiles, or count and percentage, as appropriate). |
Countries
United States
Contacts
CONTACTThe Ohio State University Comprehensive Cancer Center
PRINCIPAL_INVESTIGATORBrittany L Dulmage, MD
Ohio State University Comprehensive Cancer Center
Outcome results
None listed