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临床试验/CTRI/2025/12/099480
CTRI/2025/12/099480尚未招募不适用

Characteristics of peripheral neuropathy and its impact on quality of life, physical function in non-metastasis breast cancer patients.

Sri Ramachandra Institute Of Higher Education Research1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年12月29日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1

研究概览

简要总结

This cross sectional observational study aims to evaluate the characteristics of chemotherapy induced peripheral neuropathy and its impact on quality of life and physical function in non metastatic breast cancer patients who have completed more than three cycles of chemotherapy (adriamycin, docetaxel, cyclophosphamide or combinations) regardless of surgery or radiotherapy status. Neuropathy symptoms will be assessed using the EORTC QLQ-CIPN20 questionnaire and the Revised Total Neuropathy Score (RTNS). Vibration perception threshold assessed  using a biothesiometer. Physical function and fall risk will be measured by the Timed Up Go (TUG) test.These will be evaluated a single time when the participant joins the study. Data on chemotherapy details, surgery, and radiotherapy status will be documented. All assessments will be performed at baseline during study enrolment. Ethical approval has been obtained, and informed consent will be taken from all participants.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Male and female patients diagnosed with non-metastatic breast cancer.
  • Patients undergoing chemotherapy and/or radiotherapy more than 3cycles.

排除标准

  • Use of assistive devices or walking aids, indicating reduced mobility.
  • Pre-existing peripheral neuropathy from causes other than chemotherapy (e.g., diabetes, toxicity, infection).
  • Advanced musculoskeletal disorders such as severe osteoarthritis, rheumatoid arthritis, chronic low back pain, or fibromyalgia with marked functional limitation.
  • Severe cognitive or psychiatric impairment that may interfere with reliable reporting or test completion.
  • Other neurological disorders affecting gait or sensory function (e.g., stroke, Parkinson’s, multiple sclerosis).

研究者

申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Surya S

Sri Ramachandra Institute Of Higher Education Research

研究点 (1)

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