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

Gynecologic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03089892
• Other study ID #: CRF-TSGH02
• 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
• 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.

Related Conditions & MeSH terms

• Chemotherapy
• Fatigue
• Gynecologic Cancer

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)