Low-Level Laser in Treatment of Head and Neck Lymphedema: A Pilot Study
調査の概要
詳細な説明
Primary aim:
To determine the feasibility of the use of LLLT for HNC survivors with lymphedema, specifically to 1) obtain recruitment estimates and determine barriers to recruitment; 2) identify barriers to implementation; 3) assess safety; and 4) evaluate patient satisfaction.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、アメリカ、19104
- University of Pennsylvania Abramson Cancer Center
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- >18 years of age
- Completion of either postoperative radiation or chemoradiation therapy
- No evidence of cancer
- Having head and neck external lymphedema
- Either completion of lymphedema therapy or not in active lymphedema therapy
- Ability to speak and read English
- Able to provide informed consent
Exclusion Criteria:
Patients will be excluded if they have any of the following medical conditions that would prohibit the safe implementation of LLLT: pregnancy; photosensitivity; chronic inflammatory diseases; venous thrombosis; history of severe trauma; medication that affects body fluid and electrolyte balance; use of high doses of non-steroidal anti-inflammatory drugs; or pre-existing skin rash, ulceration, open wound in the treatment area; and allergic and other systemic skin diseases.
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：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：Low-level laser therapy
Single arm
|
Low-level laser therapy
|
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 |
|---|---|---|
|
Number of Participants Consented and Enrolled in Study
時間枠：Approximately 5-month recruitment window
|
Number of participants who consented the study and number of participants who enrolled in the study
|
Approximately 5-month recruitment window
|
|
Number of Participants Completed the Study Visits
時間枠：Approximately 10 weeks, from baseline visit to 4-week post-intervention visit
|
Number of participants who completed the study visits
|
Approximately 10 weeks, from baseline visit to 4-week post-intervention visit
|
|
Number of Participants With Adverse Events
時間枠：Approximately 10 weeks, from baseline visit to 4-week post-intervention visit
|
Number of participants who experienced adverse events during the course of the study.
|
Approximately 10 weeks, from baseline visit to 4-week post-intervention visit
|
|
Number of Participants Who Were Satisfied With Study Intervention.
時間枠：at 4-week post-intervention visit
|
Participants were interviewed by the study staff to ask whether they were satisfied or unsatisfied with the study intervention (low-level laser therapy).
|
at 4-week post-intervention visit
|
協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。