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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03089892
Other study ID # CRF-TSGH02
Secondary ID
Status Recruiting
Phase N/A
First received March 20, 2017
Last updated February 11, 2018
Start date October 19, 2016
Est. completion date December 31, 2018

Study information

Verified date February 2018
Source Tri-Service General Hospital
Contact Cheng-Chang Chang, M.D., Ph.D.
Phone 886-2-87923311
Email sundoor66@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender Female
Age group 20 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan Tri-Service General Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Other Cytokine and immune markers 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)
Primary Cancer-related fatigue evaluation by brief fatigue inventory-Taiwanese form(BFI-T) 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)
Secondary Quality of life assessments by functional assessment of cancer therapy-general 7 (FACT-G7) 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)
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