A Perspective Study of Cancer-related Fatigue in Gynecologic Cancer Patients Under Chemotherapy
Chemotherapy is effective and most often used to treat cancer. The common drugs used on gynecologic cancer treatment include platinum compounds like cisplatin and carboplatin, which combined with taxane, topotecan, or liposomal doxorubicin to date. The most side effects of chemotherapy are esophagitis, mucositis, anxiety, nausea, vomiting, abdominal convulsion, painful swallowing, fatigue and sometimes diarrhea, dizziness, allergy (rash, itching), neutropenia, thrombocytopenia (fever, chills, cough, pain), anemia and bleeding.
Cancer-related fatigue (CRF), an indicator of quality of life, is a highly prevalent symptom (75-80%) during treatment and in patients with advanced cancer, yet is sometimes ignored. Fatigue affected their life more than pain. Proposed criteria for CRF have been adopted for inclusion in the International Statistical Classification of Disease and Related Health Problems, Tenth Revision, Clinical Modification (ICD-10-CM). Therefore, more in-depth researches on CRF are needed in Taiwan. Patients with CRF in need of improvement, commonly use nutrition supplements, acupuncture, healthy food, massage, drugs, etc. Hence, patients with CRF could consult their vital physician for an appropriate treatment. Furthermore, several drugs could be chosen to relieve CRF, including anemia drugs, antipsychotics or Astragalus polysaccharides extract.
The objective of this retrospective study is to collect and analyze the medical records of gynecologic cancer patients who who had received chemotherapy with or without prescription drug treatment for cancer-related fatigue in the Department of Obstetrics & Gynecology of Tri-Service General Hospital from December 1st, 2015 to Dec 31st, 2018. This study will compare the fatigue improvement profile by different chemotherapy regimens, tumor stage, CRF treatment, etc. and investigate the association between the profile of fatigue improvement and fatigue cluster (weight loss and other symptoms of functional assessment of cancer therapy). This study will also collect blood specimens and analyze the correlation of the cytokine profile and/or immune profile.These results will supply physicians with more understanding about CRF, and help them to enhance the quality on gynecologic cancer care to being perfected in the future.
研究概览
详细说明
研究类型
注册 (预期的)
联系人和位置
学习地点
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Taipei、台湾
- 招聘中
- Tri-Service General Hospital
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接触:
- Cheng-Chang Chang, M.D., Ph.D.
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首席研究员:
- Cheng-Chang Chang, M.D., Ph.D.
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副研究员:
- Mu-Hsien Yu, M.D., Ph.D.
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副研究员:
- Yu-Chi Wang, M.D., Ph.D.
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副研究员:
- Salvatore Giovanni Vitale, M.D.
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Gynecologic cancer patients under chemotherapy.
- aged 20 and above.
Exclusion Criteria:
- Patients who had been enrolled for other investigational drug trials within the data collection period of this study.
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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Gynecologic cancer patients
Gynecologic cancer patients under chemotherapy
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Cancer-related fatigue evaluation by brief fatigue inventory-Taiwanese form(BFI-T)
大体时间:Change from baseline cancer-related fatigue at each chemotherapy cycle (each cycle is 21 or 28 days)
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BFI was commonly used to evaluate the cancer-related fatigue during the clinical practice.
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Change from baseline cancer-related fatigue at each chemotherapy cycle (each cycle is 21 or 28 days)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Quality of life assessments by functional assessment of cancer therapy-general 7 (FACT-G7)
大体时间:Change from baseline Quality of life at each chemotherapy cycle (each cycle is 21 or 28 days)
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FACT-G7 was usually used to assess the quality of life of cancer patients during the clinical practice.
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Change from baseline Quality of life at each chemotherapy cycle (each cycle is 21 or 28 days)
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Cytokine and immune markers
大体时间:Change from baseline cytokine and immune index at each chemotherapy cycle (each cycle is 21 or 28 days)
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Cytokine and immune markers will be assessed from blood of cancer patients during the each chemotherapy cycle.
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Change from baseline cytokine and immune index at each chemotherapy cycle (each cycle is 21 or 28 days)
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合作者和调查者
调查人员
- 首席研究员:Cheng-Chang Chang, M.D., Ph.D.、Tri-Service General Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- CRF-TSGH02
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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