The impact of cardio-oncology rehabilitation on dyspnea, fatigue, lymphedema and quality of life in breast cancer patients receiving chemo-radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- 1) Modified Borg Scale
研究概览
简要总结
Breast cancer is the most prevalent cancer among women worldwide and represents nearly a quarter of all malignant tumors in women, with over one million new cases diagnosed annually. It is a complex and heterogeneous disease characterized by diverse histological patterns, biological features, and clinical behaviors. While advancements in early detection and treatment have improved survival rates, persistent treatment-related symptoms, such as dyspnea, fatigue, and lymphedema, significantly impact the quality of life for survivors. These symptoms are often underdiagnosed and inadequately managed, particularly respiratory impairments linked to chemotherapy and radiotherapy, including pulmonary toxicity from agents like docetaxel. Inspiratory Muscle Training (IMT) and Positive Expiratory Pressure (PEP) IMT have shown promise in improving respiratory function and endurance, but their role in managing dyspnea and enhancing quality of life in breast cancer patients undergoing treatment remains underexplored. Addressing this gap, this study aims to evaluate the effectiveness of IMT and PEP IMT within a cardio-oncology rehabilitation framework. By examining their impact on dyspnea, fatigue, lymphedema, and overall quality of life, the research seeks to provide evidence-based insights to optimize care for breast cancer patients undergoing chemo-radiotherapy, advancing toward more holistic and effective treatment strategies.
Null Hypothesis H0 - There is no significant effect of PEP IMT than traditional methods in cardio-oncology rehabilitation on dyspnea, fatigue, lymphedema and quality of life in breast cancer patients receiving chemo-radiotherapy.
Alternate Hypothesis H1 - There is significant effect of PEP IMT than traditional methods in cardio-oncology rehabilitation on dyspnea, fatigue, lymphedema and quality of life in breast cancer patients receiving chemo-radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female breast cancer patients diagnosed with Stage I-III.
- •Stable patients with breast cancer who have completed the adjuvant treatment or were allowed to undergo the treatment.
- •Willingness to participate in cardio-oncology rehabilitation sessions.
- •Ability to comprehend and respond to questionnaires or assessments related to dyspnea, fatigue, lymphedema, and quality of life.
- •Ability to provide informed consent for participation in the study.
排除标准
- •Presence of uncontrolled cardiac symptoms.
- •Patients with metastatic breast cancer or Stage IV disease.
- •History of significant cardiovascular diseases or conditions that contraindicate participation in cardio-oncology rehabilitation.
- •Severe psychiatric disorders that may impede participation in the study or comprehension of study procedures.
- •Pregnancy, as it may affect the interpretation of study outcomes and participation in rehabilitation exercises.
结局指标
主要结局
1) Modified Borg Scale
时间窗: 4 weeks
2) Respiratory muscle function
时间窗: 4 weeks
次要结局
- 1) Arm circumference(2) EORTC QLQ-C30 questionnaire)
研究者
Aaliya Javed
SGT University