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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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Taipei, Taiwan
- Rekruttering
- Tri-Service General Hospital
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Ta kontakt med:
- Cheng-Chang Chang, M.D., Ph.D.
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Hovedetterforsker:
- Cheng-Chang Chang, M.D., Ph.D.
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Underetterforsker:
- Mu-Hsien Yu, M.D., Ph.D.
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Underetterforsker:
- Yu-Chi Wang, M.D., Ph.D.
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Underetterforsker:
- Salvatore Giovanni Vitale, M.D.
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Gynecologic cancer patients
Gynecologic cancer patients under chemotherapy
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Cancer-related fatigue evaluation by brief fatigue inventory-Taiwanese form(BFI-T)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Quality of life assessments by functional assessment of cancer therapy-general 7 (FACT-G7)
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Cytokine and immune markers
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Cheng-Chang Chang, M.D., Ph.D., Tri-Service General Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CRF-TSGH02
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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