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A Perspective Study of Cancer-related Fatigue in Gynecologic Cancer Patients Under Chemotherapy

2018年2月11日 更新者:Cheng-Chang Chang、Tri-Service General Hospital

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

地位

未知

详细说明

About 60 gynecologic cancer patients' medical records are expected to collect and analyze in this retrospective study. The data collection from medical records of gynecologic cancer patients who had received chemotherapy with or without prescription drug treatment for cancer-related fatigue include the demographic information (e.g., height, weight, age, sex, tumor stage, time from tumor diagnoses, prescription drug of cancer-related fatigue treatment and chemotherapy toxicities), the diagnosis and severity of cancer-related fatigue, functional assessment of cancer therapy and so on.

研究类型

观察性的

注册 (预期的)

60

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Taipei、台湾
        • 招聘中
        • Tri-Service General Hospital
        • 接触:
          • Cheng-Chang Chang, M.D., Ph.D.
        • 首席研究员:
          • Cheng-Chang Chang, M.D., Ph.D.
        • 副研究员:
          • Mu-Hsien Yu, M.D., Ph.D.
        • 副研究员:
          • Yu-Chi Wang, M.D., Ph.D.
        • 副研究员:
          • Salvatore Giovanni Vitale, M.D.

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

女性

取样方法

非概率样本

研究人群

Gynecologic cancer patients had accepted prescription drug treatment for cancer-related fatigue under chemotherapy in the Department of Obstetrics & Gynecology of Tri-Service General Hospital from December 1st, 2015 to Dec 31st, 2018.

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Gynecologic cancer patients
Gynecologic cancer patients under chemotherapy

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
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)
BFI was commonly used to evaluate the cancer-related fatigue during the clinical practice.
Change from baseline cancer-related fatigue at each chemotherapy cycle (each cycle is 21 or 28 days)

次要结果测量

结果测量
措施说明
大体时间
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)
FACT-G7 was usually used to assess the quality of life of cancer patients during the clinical practice.
Change from baseline Quality of life at each chemotherapy cycle (each cycle is 21 or 28 days)

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)
Cytokine and immune markers will be assessed from blood of cancer patients during the each chemotherapy cycle.
Change from baseline cytokine and immune index at each chemotherapy cycle (each cycle is 21 or 28 days)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

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

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年10月19日

初级完成 (预期的)

2018年12月31日

研究完成 (预期的)

2018年12月31日

研究注册日期

首次提交

2017年3月20日

首先提交符合 QC 标准的

2017年3月20日

首次发布 (实际的)

2017年3月24日

研究记录更新

最后更新发布 (实际的)

2018年2月13日

上次提交的符合 QC 标准的更新

2018年2月11日

最后验证

2018年2月1日

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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