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治験 NCT05528263 (PACT)（対象：鍼治療、早期乳癌、化学療法誘発末梢神経障害、乳癌ステージI、乳癌ステージII、乳癌ステージIII）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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Preventing Chemotherapy-Induced Peripheral Neuropathy With Acupuncture (PACT Trial)
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 NCT05528263 (PACT) は 介入研究 臨床試験 で、鍼治療、早期乳癌、化学療法誘発末梢神経障害、乳癌ステージI、乳癌ステージII、乳癌ステージIII に関するものです。現在は 実施中／登録終了 で、2022年9月8日 から開始しています。89 名の参加者 の募集が計画されています。この治験は Dana-Farber Cancer Institute によって主催され、2026年2月28日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年5月4日 です。
概要
This research is being done to determine whether acupuncture can help prevent or lessen chemotherapy-induced peripheral neuropathy (CIPN), a side effect of some kinds of chemotherapy that causes pain, numbness, tingling, swelling, or muscle weakness mostly in the hands or feet.
This research will also help determine whether acupuncture can improve quality of life in patients receiving taxane-based chemotherapy for the treatment of breast cancer.
The names of the study activities involved in this study are/is:
- Acupuncture treatments for participants in the Acupuncture Group
- Nature videos with a relaxation exercise for participants in the Relaxation/ Exercise Group
The Comprehensive and Integrative Medicine Institute (CIMI) of South Korea is supporting this research study by providing funding.
詳細説明
This study randomly assigns patients with breast cancer who are starting a chemotherapy program that includes a Taxane to one of two groups:
- The Acupuncture Group will receive acupuncture treatments for 12 weeks during chemotherapy treatment.
- The Relaxation Exercise Group will receive a program of weekly videos accompanied by a relaxation exercise. Both programs will last 12 weeks.
Participants will be asked to complete questionnaire 12 weeks after the completion of the acupuncture or relaxation exercise program, so participants be on this research study for up to 24 weeks (6 months).
It is expected that about 80 people will take part in this research study.
公式タイトル
Preventing Chemotherapy-Induced Peripheral Neuropathy With Acupuncture, A Randomized Controlled Trial (PACT Trial)
疾患／病気
鍼治療早期乳癌化学療法誘発末梢神経障害乳癌ステージI乳癌ステージII乳癌ステージIIIその他の研究識別子
- PACT
- 22-269
NCT番号
開始日
2022-09-08
最終更新日
2025-05-04
終了予定日
2026-02-28
目標参加者数
89
試験の種類
介入研究
治験の相・段階
該当なし
状況
実施中／登録終了
キーワード
Acupuncture
Early-stage Breast Cancer
Chemotherapy-induced Peripheral Neuropathy
Breast Cancer Stage I
Breast Cancer Stage II
Breast Cancer Stage III
Early-stage Breast Cancer
Chemotherapy-induced Peripheral Neuropathy
Breast Cancer Stage I
Breast Cancer Stage II
Breast Cancer Stage III
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 |
|---|---|
実験的Acupuncture * Breast cancer patients will be recruited who are scheduled to receive taxane-based chemotherapy (with or without anti-HER2 therapy) and who have no neuropathic symptoms at baseline.
40 participants will be randomized into the acupuncture Arm:
* The acupuncture arm will receive a standardized acupuncture protocol 1-2 times a week for 12 weeks (a total of 14 sessions). | 鍼治療 Standardized acupuncture protocol 1-2 times a week for 12 weeks (a total of 14 sessions). |
実薬対照薬Nature scenery videos with relaxation exercise * Breast cancer patients will be recruited who are scheduled to receive taxane-based chemotherapy (with or without anti-HER2 therapy) and who have no neuropathic symptoms at baseline.
40 Participants will be randomized into the Control Arm:
* The control arm will receive and watch videos with nature scenery with a relaxation exercise guide 1-2 times a week for 12 weeks (a total of 14 sessions) | Nature Scenery with a Relaxation Exercise Watch nature scenery videos with a relaxation exercise guide 1-2 times a week for 12 weeks (a total of 14 sessions) |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Change in severity of CIPN, defined by mean change in EORTC QLQ-CIPN20 sensory score | The primary endpoint is the change in severity of CIPN, defined as the average change from baseline (12-week to baseline) in the EORTC Quality of Life - Chemotherapy Induced Neuropathy 20 (QLQ-CIPN20) sensory subscale score (9 items). Using a 4-point Likert scale (1 = "not at all," 2 = "a little," 3 = "quite a bit," and 4 = "very much"), individuals indicate the degree to which they have experienced sensory, motor, and autonomic symptoms during the past week. A higher score means greater severity of CIPN. The total and three domain scores are calculated and linearly transformed into 0-100 scales according to the scoring manual. A score of 100 indicates the worst CIPN symptom. | baseline to 12 weeks |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Incidence of CIPN between intervention arms - AOCIPN | AOCIPN is defined as an increase of 2.5 points or larger in the QLQ-CIPN 20 sensory score at any time point relative to baseline or reported "mild" or "a little bit" or higher in PRO-CTCAE CIPN "Severity" and "Interference" items during the study intervention period (baseline to week 12). | baseline to week 12 |
Incidence of CIPN between intervention arms - G2CIPN | G2CIPN is defined a 20-point or greater increase from baseline at any time point in QLQ-CIPN20 total score or grade-2 in PRO-CTCAE CIPN, which is defined as reporting the severity of numbness and/or tingling AND interference of with daily activities ≥ 1 (mild/ a little bit) during the study period at any time point. | baseline to 12 Weeks |
Relative dose intensity (RDI) | Received or relative dose intensity (RDI) refers to the amount and timing of chemotherapy actually delivered versus the expected dose and schedule. The relative dose intensity (RDI) will be calculated for each participant and compared between treatment arms using two-sample t-tests or Wilcoxon rank-sum tests, depending upon normality of the data. | baseline to week 24 |
Maximum CIPN score | Maximum CIPN score will be assessed through the EORTC Quality of Life - Chemotherapy Induced Neuropathy 20 (QLQ-CIPN20) sensory subscale score (9 items). Using a 4-point Likert scale (1 = "not at all," 2 = "a little," 3 = "quite a bit," and 4 = "very much"), individuals indicate the degree to which they have experienced sensory, motor, and autonomic symptoms during the past week. A higher score means greater severity of CIPN. The maximum CIPN sensory score change (post-pre) for each patient during the intervention will be compared between the randomized treatment arms. | pre-treatment, and at weeks 3, 6, 9, and 12 during the intervention up to 12 weeks |
Changes in mean scores of pain intensity | CIPN pain intensity will be measured using a past 7 days, 0-10 numerical rating scale diary. A higher score indicates greater pain intensity. | Baseline, Week 12, and Week 24 |
Changes in the total mean scores of the Pittsburgh Sleep Quality Index (PSQI) | The PSQI is a 19-item self-reported questionnaire that assesses sleep quality for the preceding month. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. | Baseline, Week 12, and Week 24 |
Changes in the total and subscales of EORTC QLQ-C30 | Quality of life and cancer treatment-related symptoms will be assessed using the EORTC-QLQ-C30. The QLQ-C30 consists of 30 items that are grouped within global health status/quality of life (1 - 7 points, higher scores = greater quality of life), functional (e.g., physical or cognitive; 0 - 100 transformed scores, higher = better function), or symptom (e.g., insomnia, fatigue; 0 - 100 transformed scores, higher = worse symptoms) subscales. | Baseline, Week 12, and Week 24 |
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
- History of histologically proven stage I-III breast cancer, without evidence of distant metastasis
- Scheduled to receive adjuvant or neoadjuvant taxane-based chemotherapy (with or without HER-2 directed therapy or with or without immunotherapy). Patient must enroll before the second infusion of a taxane.
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Signed informed consent
Previous receipt of CIPN-inducing chemotherapy agents (1 prior dose of a taxane is allowed).
Unstable cardiac disease or myocardial infarction within 6 months prior to study entry
Wearing a pacemaker or implantable cardioverter-defibrillator
Uncontrolled seizure disorder
History of pre-existing peripheral neuropathy
Use of acupuncture within the 3 months prior to study enrollment
Self-report of any CIPN symptoms via staff-administered PRO-CTCAE CIPN, defined as either:
- Report of "mild", "moderate", "severe", "very severe" on the Severity Item on PRO-CTCAE CIPN assessment
- Report of "a little bit", "somewhat", "quite a bit", "very much" on the Interfere Item on PRO-CTCAE CIPN assessment
Dana-Farber Cancer InstituteThe Comprehensive and Integrative Medicine Institute of South Korea責任者
Weidong Lu, MB, MPH, PhD, 研究責任者, Principal Investigator, Dana-Farber Cancer Institute
連絡先情報がありません。
1 1カ国の場所
Massachusetts
Dana Farber Cancer Institute, Boston, Massachusetts, 02215, United States