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治験 NCT05787834（対象：乳癌）は募集中です。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。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
Home-based Respiratory Muscle Training for Minimizing Side Effects in Patients Undergoing Treatment for Breast Cancer
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます！「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT05787834 は 介入研究 臨床試験 で、乳癌 に関するものです。現在は 募集中 で、2023年10月16日 から開始しています。130 名の参加者 の募集が計画されています。この治験は Roswell Park Cancer Institute によって主催され、2029年10月16日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年3月14日 です。
概要
This clinical trial evaluates whether home-based respiratory muscle training is useful for minimizing side effects in patients undergoing treatment for breast cancer. Over-activation of the nervous system during breast cancer treatment can result in heart- and lung-related side effects which have the potential to reduce a patient's quality of life. Aerobic exercise can help prevent the development of these side effects. However, engaging in regular aerobic exercise may be difficult for breast cancer patients who are actively undergoing treatment. Respiratory muscle training (RMT) involves a series of breathing and other exercises that are performed to improve the function of the respiratory muscles through resistance and endurance training. Home-based RMT may represent a more feasible approach for reducing side effects in patients undergoing treatment for breast cancer.
詳細説明
PRIMARY OBJECTIVE:
I. To assess the feasibility of delivering a 12-week RMT program during adjuvant and neoadjuvant chemotherapy used to treat breast cancer.
SECONDARY OBJECTIVES:
I. To determine how cardiac autonomic regulation, cardiorespiratory fitness, exercise performance, and quality-of-life (QoL) are affected by RMT during breast cancer treatment.
II. To assess how RMT affects patient reported symptoms linked to sympathetic overactivation such as stress, fatigue, dyspnea, when performed during chemotherapy.
EXPLORATORY OBJECTIVE:
I. To determine if RMT reduces circulating biomarkers of autonomic dysfunction, inflammation, and cardiac injury in breast cancer patients undergoing treatment.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: patients receive lower resistance RMT using a respiratory muscle training device for 12 weeks.
GROUP II: Patients undergo higher resistance RMT using a respiratory muscle training device for 12 weeks on study.
公式タイトル
Respiratory Muscle Training During Breast Cancer Treatment: Effects on the Autonomic Nervous System and Cardiotoxicity
疾患／病気
乳癌その他の研究識別子
- I-3364822
- NCI-2023-01256 (登録識別子) (CTRP (Clinical Trial Reporting Program))
- I-3364822 (その他の識別子) (Roswell Park Cancer Institute)
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
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実薬対照薬Group I (low resistance RMT Group) Patients receive usual care for 12 weeks on study and a Respiratory Muscle training Device with small breathing resistance | 最良の実践 Receive usual care 医療機器の使用と評価 Wear accelerometer 呼吸筋トレーニング Undergo RMT 調査管理 Ancillary studies |
実験的Group II (Moderate to highter resistance RMT) Patients undergo RMT using a respiratory muscle training device with moderate to higher breathing resistance for 12 weeks on study. | 医療機器の使用と評価 Wear accelerometer 呼吸筋トレーニング Undergo RMT 調査管理 Ancillary studies |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Proportion of patients who participate in the study | Up to 12 weeks | |
Proportion of patients who remain on study | Up to 12 weeks | |
Proportion of patients who perform >= 3 respiratory muscle training (RMT) sessions/week | Overall compliance rates (compliance at all time points) will be estimated using 90% confidence intervals. Additionally, compliance status will be modeled as a function of time (e.g., week), and pre-specified exogenous factors (e.g., baseline age, performance status, self-reported history of exercise, breast cancer (BC) treatment received, treatment side-effects) using a generalized estimating equation (GEE) logistic regression model (auto-regressive covariance structure). Estimates of compliance rates will be obtained by time-point and tests about the appropriate contrasts of model estimates will be used to determine if there is a time trend. | Up to 12 weeks |
Proportion of patients who perform > 70% of their RMT sessions | Adherence rates (completion of \>= 70% of sessions) will be estimated using 90% confidence intervals. Additionally, compliance status will be modeled as a function of time (e.g., week), and pre-specified exogenous factors (e.g., baseline age, performance status, self-reported history of exercise, BC treatment received, treatment side-effects) using a GEE logistic regression model (auto-regressive covariance structure). Estimates of compliance rates will be obtained by time-point and tests about the appropriate contrasts of model estimates will be used to determine if there is a time trend. | Up to 12 weeks |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Change in Functional Capacity | Six minute walking test is a functional test of sub-maximum cardiorespiratory capacity. | At baseline, 6 weeks, and 12 weeks |
Change in Lower body strength | The Short Physical Performance Battery - PPB is comprised of 3 tasks: a hierarchial standing balance test (side by side, semi-tandem and tandem), 4-m habitual gait speed, and 5 sit to stand from a chair. Each task is scored (based on time) from 0-4 Points (p) and then summarized into a total score of 0-12 p, where 12 p represents the highest performance. | At baseline, 6 weeks, and 12 weeks |
Assess Dyspnea | Dyspnea will be measured by the Dyspnea-12 questionnaire which contains 12 items on a scale of 0(none), mild (1) and Severe (3) and evaluates the physical and affective dimensions of dyspnea. Higher scores represent greater severity. | At baseline, 6 weeks, and 12 weeks |
Assess Fatigue | Fatigue will be measured using the Brief Fatigue Inventory (BFI). Each item is scored 1 (no fatigue) to 10 (as bad as you can imagine) to assess the severity of fatigue and its impact on daily functioning. A global fatigue score is obtained by averaging all the items (1-3: mild, 4-7: moderate, 8-10: severe) | At baseline, 6 weeks, and 12 weeks |
Change in Quality of life | Quality of life collected by the EORTC Core Quality of Life Questionnaire (EORTC-QLQ-30) - a 30 question questionnaire with lower higher scores indicating a positive situation. | At baseline, 6 weeks, and 12 weeks |
Sleep quality | Will be measured by the Pittsburg Sleep Quality Index a self reported inventory to measure sleep quality. Questions are answered on 0-3 scale with higher scores indicating greater sleep pathology. | At baseline, 6 weeks, and 12 weeks |
Anxiety | The Beck Anxiety Score is a measurement on a scale from 0 to 63 obtained by using the Beck Anxiety Inventory tool to assess symptoms of anxiety. A higher score correlates to increased anxiety whereas a lower score expresses a lower amount of anxiety. | At baseline, 6 weeks, and 12 weeks |
Self-reported measures of stress | Stress will be measured by the Perceived Stress Scale. The scale measures the degree to which one perceives situations in one's life as stressful on a Likert Scale of 0 to 4 with 0 indicating never, and 4 indicating very often. Higher scores indicate higher levels of perceived stress | At baseline, 6 weeks, and 12 weeks |
Self-reported measures of depression | Will be measured by the Centers for Epidemiology Studies Depression Scale used as a screen to identify clinically significant depression; a cutoff score of greater than 16 has been shown to correlate with clinically significant depression. In addition, a score between 8 and 15 has been used to define subsyndromal depression. The possible range of scores is zero to 60, with the higher scores indicating more symptoms, weighted by frequency of occurrence during the past week. | At baseline, 6 weeks, and 12 weeks |
Measures of fitness | Will be measured with a submaximal exercise test. A 6 minute cycling exercise test. | At baseline, 6 weeks, and 12 weeks |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- Documented breast cancer and scheduled to receive adjuvant or neoadjuvant chemotherapy
- Age >= 18 years old
- Cognitively capable of following direction and performing the intervention
- Able to speak, read and comprehend English language
- Understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
- Have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, heart failure or psychiatric illness/social situations that would limit compliance with study requirements
- Prior radiation to the left chest wall
- Patients with medical frailty (clinical discretion)
- Are pregnant or nursing
- Unwilling or unable to follow protocol requirements
- Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study intervention
Roswell Park Cancer Institute試験中央連絡先
連絡先: ASK RPCI, 1-877-275-7724, [email protected]
1 1カ国の場所
New York
Roswell Park Cancer Institute, Buffalo, New York, 14263, United States
Ellis Levine, MD, 連絡先, 716-845-3152, [email protected]
Ellis Levine, MD, 研究責任者
募集中