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治験 NCT06754293 (RE-MS)（対象：Musculoskeletal Symptoms、乳癌、内分泌療法、アロマターゼ阻害剤）は実施中／登録終了です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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復旦大学Evaluating the Efficacy of Structured Exercise Interventions in Alleviating Aromatase Inhibitor-Induced Arthralgia in Breast Cancer Survivors: a Pilot Study Protocol (RE-MS) 24 在宅 運動療法
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治験番号 NCT06754293 (RE-MS) は 介入研究 臨床試験 で、Musculoskeletal Symptoms、乳癌、内分泌療法、アロマターゼ阻害剤 に関するものです。現在は 実施中／登録終了 で、2024年12月1日 から開始しています。24 名の参加者 の募集が計画されています。この試験は 復旦大学 によって主導され、2025年2月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2024年12月31日 です。
概要
Endocrine therapy represents a foundational approach for managing hormone receptor-positive breast cancer, with treatment typically spanning 5 to 10 years. Although its clinical efficacy is well-established, medications like aromatase inhibitors frequently result in musculoskeletal (MS) complications, such as joint discomfort, stiffness (especially in the morning), carpal tunnel syndrome, tenosynovitis, myalgia, and ...もっと見る
公式タイトル
Evaluating the Efficacy of Structured Exercise Interventions in Alleviating Aromatase Inhibitor-Induced Arthralgia in Breast Cancer Survivors: a Pilot Study Protocol
疾患名
Musculoskeletal Symptoms乳癌内分泌療法アロマターゼ阻害剤その他の研究識別子
- RE-MS
- 138103810480184013133114411411
主目的
支持療法
割付方法
無作為化
介入モデル
並行割当
盲検化
単盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Exercise group The intervention group will participate in a home-based exercise program alongside standard rehabilitation guidance. Patients will receive exercise materials developed by the intervention team, along with a detailed explanation of the program, including its components, specific exercises, and expected benefits.The exercise program focuses on aerobic warm-ups and functional training, targeting key areas such as the ha...もっと見る | rehabilitation exercise The intervention group will participate in a home-based exercise program alongside standard rehabilitation guidance. Patients will receive exercise materials developed by the intervention team, along with a detailed explanation of the program, including its components, specific exercises, and expected benefits.
The exercise program focuses on aerobic warm-ups and functional training, targeting key areas such as the ...もっと見る |
非介入control group Patients in the control group will receive standard guidance related to breast cancer endocrine therapy, including general information on exercise rehabilitation for managing bone and joint symptoms. This guidance allows patients the flexibility to choose their preferred form, type, and intensity of exercise. In addition, psychological counseling and health education will be provided to support their overall well-bei...もっと見る | 該当なし |
主要評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
WOMAC | Developed in 1988 by Bellamy and Buchanan, the WOMAC index evaluates pain, stiffness, and physical function in knee or hip osteoarthritis patients over the past 48 hours . The WOMAC 3.1 version contains 24 items scored using either a VAS (0-100 mm) or a 5-point Likert scale (0-4). This study will use the VAS version, with pain (5 items, 0-500 points), stiffness (2 items, 0-200 points), and physical function (17 items, 0-1700 points) subscales. Total scores range from 0 to 2400, with higher scores indicating greater symptom burden. Scores below 800 denote mild symptoms, 800-1200 moderate, and above 1200 severe symptoms. | Baseline and 1month |
Grip strength | Grip strength will be measured by the exercise group at baseline (0 months) and at 1, 3, and 6 months of intervention. An electronic hand dynamometer (CAMRY EH10) will be used for assessment. Participants will perform the test by extending their arms straight down with their palms facing their thighs, abducting their dominant upper limb (on the non-surgical side) by 30 degrees. The grip strength value, displayed in kilograms on the dynamometer, will represent the maximum force achieved. To ensure accuracy, participants will be instructed not to swing their arms, squat, or allow the dynamometer to touch their body during the test. Each participant will undergo three assessments, with a 60-second interval between measurements, and the highest value will be used for analysis. | Baseline and 1month |
M-SACRAH | The SACRAH, developed by Leeb et al. in 2003, is a validated tool for assessing chronic rheumatic hand conditions. The Modified Score for the Assessment of Chronic Rheumatoid Affections of the Hands (M-SACRAH), a shorter and simplified version of SACRAH, has shown similar reliability and representativeness. M-SACRAH contains 12 items scored using a visual analog scale (VAS, 0-100 mm) across three dimensions: pain (2 items, 0-200 points), stiffness (2 items, 0-200 points), and physical function (8 items, 0-800 points). Higher scores indicate more severe symptoms, with a total possible score of 0-1200. | Baseline and 1month |
BCTQ | The BCTQ consists of 11 items assessing symptom severity (Symptom Severity Score, SSS) and 8 items evaluating functional status (Function Scale Score, FSS) . The SSS addresses issues such as nocturnal pain, frequency of night awakenings, daytime wrist pain, hand numbness or weakness, and difficulty handling small objects. The FSS evaluates activities like writing, buttoning clothes, carrying groceries, and performing household tasks. Each item is rated on a 5-point scale, with 1 indicating "none" and 5 indicating "severe." The average score across all items represents the final score. | Baseline and 1month |
Range of Motion | Tools for ROM measurement include goniometers, rulers, and electronic measuring devices. The goniometer comprises a stationary arm (proximal arm) with a semicircular (0°-180°) or circular (0°-360°) angle scale and a movable arm (distal arm) attached via a rivet. The movable arm rotates with the limb, allowing ROM to be read from the scale. | Baseline and 1month |
参加アシスタント
適格基準
対象年齢
小児, 成人, 高齢者
対象性別
全て
- Pathologically confirmed hormone receptor-positive breast cancer (stage I, II, III).
2. Initiation of treatment with aromatase inhibitors (e.g., anastrozole, letrozole, exemestane).
3. Postmenopausal women, including those with surgically induced menopause. 4. Clear consciousness, no cognitive or communication impairments, and able to comply with the intervention.
5. Informed consent obtained, with voluntary participation in the study. 6. Bone and joint symptoms with a Brief Pain Inventory (BPI) score of ≥3, or presence of at least one of the following risk factors: elevated bone turnover markers, reduced vitamin D levels, increased inflammatory cytokines, elevated C-reactive protein, or elevated rheumatoid factor.
7. Not participating in any physical therapy or exercise-based interventions that may interfere with this study.
-
- 1. Recurrence of breast cancer or distant metastasis. 2. Presence of other malignancies. 3. Diagnosed rheumatoid arthritis, bone and joint trauma, or other severe bone and joint diseases.
4. Bone mineral density T-score <-2.5. 5. Presence of absolute contraindications to exercise.
Shanghai Cancer Hospital, China責任者
Lingyun Jiang, 主任研究者, Principal Investigator, Fudan University
連絡先情報がありません。
1 1カ国の場所
XuHui
Shanghai Cancer Center, Shanghai, XuHui, 200030, China