A 24 Weeks Activity Program in Patients With Early Breast Cancer Receiving Aromatase Inhibitor Therapy. A Multicenter Randomized Phase III Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 375
- 试验地点
- 63
- 主要终点
- Incidence of muscle or joint pain/stiffness as measured by BPI-SF single-item worst pain score
研究概览
简要总结
The primary aim of the trial is to investigate if a simple outdoor walking intervention, which is practicable under real-life conditions, beginning at the start of adjuvant aromatase inhibitor (AI) therapy, can prevent the occurrence of muscle or joint pain/stiffness in breast cancer patients.
详细描述
After tumor removal, patients with hormone receptor positive breast cancer tumors often receive adjuvant endocrine treatment, with the use of an aromatase inhibitor (AI) being standard of care in the population of postmenopausal women. Common side effects of AI therapy are joint pain, muscle pain, stiffness, fatigue, hot flashes, and weight gain. Arthralgia and/or myalgia can result in lower physical activity and can negatively influence quality of life (QoL). In addition, muscle or joint pain/stiffness are among the main reasons for non-compliance and discontinuation of AI therapy. Because AI therapy is usually administered for 5 and sometimes even 10 years, this is a major clinical challenge.
For breast cancer patients undergoing AI therapy, physical activity can provide potential benefit by reducing muscle/joint pain and fatigue and can thus improve QoL. The preventive effect of physical activity on AI side effects, however, remains elusive. In addition, activity programs to reduce AI side effects have so far mostly been rather complex. The primary aim of the trial is to investigate if a simple outdoor walking intervention, which is practicable under real-life conditions, beginning at the start of adjuvant AI therapy, can prevent the occurrence of muscle or joint pain/stiffness in breast cancer patients.
Furthermore, this trial will assess the effect of physical activity on symptom burden in general and quality of life in patients receiving adjuvant AI therapy. During the follow-up phase, the trial will assess whether this intervention leads to a sustained change in lifestyle regarding activity, less pain, and better treatment adherence in the intervention group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent according to Swiss law and ICH/GCP regulations before registration and prior to any trial specific procedures.
- •Histologically confirmed hormone-receptor-positive newly diagnosed breast cancer, AJCC (American Joint Committee on Cancer) stage I-III
- •Patient had tumor removal by breast conserving surgery or mastectomy, followed by chemotherapy (if indicated) and/or radiotherapy (if indicated)
- •Patient is starting adjuvant first-line endocrine treatment with an AI alone (in postmenopausal women) or combined endocrine treatment with an AI and ovarian suppression with an LHRH-agonist (in premenopausal women)
- •Patient completed the PRO Form Eligibility before registration
- •Patient is fluent in German, Italian, or French
- •Patient is willing to wear a wrist worn activity tracker for 24 weeks
- •Female patient, age ≥ 18 years
- •WHO performance status 0-2
排除标准
- •Pre-existing severe medical conditions such as heart or lung problems or musculoskeletal conditions precluding participation in the physical activity program of moderate walking a total of 150 minutes per week as determined by the local investigator
- •Mild, moderate, or severe pain (other than post-operative pain) in the last 24 hours due to muscle/joint pain on the BPI-SF single item "worst pain" ("worst pain" ≥3) within 7 days prior to registration
- •Inoperable, locally advanced and/or metastatic breast cancer
- •Active rheumatoid arthritis
- •Neoadjuvant endocrine treatment with an AI
- •NSAIDs, acetaminophen or opioids on a regular basis (> 1 time per week)
- •Concurrent participation in other clinical trials or observational studies
- •Any other serious psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the intervention and follow-up or affect patient compliance with trial procedures.
结局指标
主要结局
Incidence of muscle or joint pain/stiffness as measured by BPI-SF single-item worst pain score
时间窗: Up to 24 weeks after randomization
Muscle or joint pain/stiffness will be assessed at baseline, 3, 9, 12, 15, 18, 21, 24 weeks after randomization by the BPI-SF questionnaire. The BPI-SF is a 14-item self-administered questionnaire which is routinely used in clinical trials to assess pain severity and pain interference with daily activities in patients with cancer. Pain severity is assessed by four items including pain at its "worst", "least", "average" in the last 24 hours and "now" (current pain), each item being rated on a 0-10 scale.
次要结局
- Fatigue(Baseline, 12 and 24 weeks and 1 and 2 years after randomization)
- QoL: Emotional scale (EORTC QLQ-C30)(Baseline, 12 and 24 weeks and 1 and 2 years after randomization)
- QoL: Cognitive scale (EORTC QLQ-C30)(Baseline, 12 and 24 weeks and 1 and 2 years after randomization)
- QoL: Social functioning scale (EORTC QLQ-C30)(Baseline, 12 and 24 weeks and 1 and 2 years after randomization)
- QoL: Physical scale (EORTC QLQ-C30)(Baseline, 12 and 24 weeks and 1 and 2 years after randomization)
- QoL: Rose scale (EORTC QLQ-C30)(Baseline, 12 and 24 weeks and 1 and 2 years after randomization)
- Nausea/Vomiting(Baseline, 12 and 24 weeks and 1 and 2 years after randomization)
- Pain (EORTC QLQ-C30)(Baseline, 12 and 24 weeks and 1 and 2 years after randomization)
- Global health status(Baseline, 12 and 24 weeks and 1 and 2 years after randomization)
- Dyspnoea(Baseline, 12 and 24 weeks and 1 and 2 years after randomization)
- AI treatment adherence (diary)(Baseline, 3, 9, 12, 15, 18, 21, 24 weeks.)
- Insomnia(Baseline, 12 and 24 weeks and 1 and 2 years after randomization)
- Appetite loss(Baseline, 12 and 24 weeks and 1 and 2 years after randomization)
- Constipation(Baseline, 12 and 24 weeks and 1 and 2 years after randomization)
- Diarrhoea(Baseline, 12 and 24 weeks and 1 and 2 years after randomization)
- Financial difficulties(Baseline, 12 and 24 weeks and 1 and 2 years after randomization)
- Hot flashes(Baseline, 12 and 24 weeks and 1 and 2 years after randomization)
- Intensity of muscle or joint pain/stiffness and its impact on everyday functioning(Baseline, 3, 9, 12, 15, 18, 21, 24 weeks and 1, 2 years after randomization)
- Walking activity(Baseline, 3, 9, 12, 15, 18, 21, 24 weeks after randomization)
- AI treatment adherence (questionnaire)(Baseline, 12, 24 weeks and 1, 2 years after randomization)