Minoxidil With or Without Low-Level Red-Light Therapy for Improving Chemotherapy-Induced Alopecia in Breast Cancer Patients
A Pilot Study of Low-Level Red-Light Therapy Combined With Topical Minoxidil Compared With Topical Minoxidil Alone in Breast Cancer Patients With Chemotherapy-Induced Alopecia
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：The Ohio State University Comprehensive Cancer Center
- 電話番号：800-293-5066
- メール：OSUCCCClinicaltrials@osumc.edu
研究場所
-
-
Ohio
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Columbus、Ohio、アメリカ、43210
- Ohio State University Comprehensive Cancer Center
-
主任研究者：
- Brittany L. Dulmage, MD
-
コンタクト：
- Brittany L. Dulmage, MD
- 電話番号：614-293-1707
- メール：Brittany.Dulmage@osumc.edu
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Arm I (minoxidil)
Patients receive minoxidil topically to the scalp daily for 6 months in the absence of unacceptable toxicity.
|
補助研究
補助研究
Given topically
他の名前：
|
|
実験的：Arm II (minoxidil, LLLT)
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.
|
補助研究
補助研究
Given topically
他の名前：
Undergo low-level red-light therapy with Revian RED LED-light cap
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Dean scale score
時間枠：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.
|
After 6 months of intervention
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Dean scale score
時間枠：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.
|
From baseline to 2, 4, and 12 months
|
|
Change in trichoscopic hair density
時間枠：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.
|
From baseline to 2, 4, 6, and 12 months
|
|
Change in Chemotherapy Alopecia Distress Scale (CADS)
時間枠：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. |
From baseline to 2, 4, 6, and 12 months
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Change in patient reported outcomes (hair loss survey)
時間枠：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.
|
From baseline to 2, 4, 6, and 12 months
|
|
Change in patient reported outcomes (feelings survey)
時間枠：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.
|
From baseline to 2, 4, 6, and 12 months
|
|
Differences in patient satisfaction (feasibility)
時間枠：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).
|
At 2, 4, and 6 months
|
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Compliance
時間枠：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).
|
At 2, 4, and 6 months
|
協力者と研究者
捜査官
- 主任研究者：Brittany L Dulmage, MD、Ohio State University Comprehensive Cancer Center
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- OSU-24393
- NCI-2026-02583 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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