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

NCT ID: NCT03089892

Last Updated: 2024-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-19

Study Completion Date

2022-03-04

Brief Summary

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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. 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.

Detailed Description

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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.

Conditions

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Gynecologic Cancer Chemotherapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Gynecologic cancer patients

Gynecologic cancer patients under chemotherapy

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tri-Service General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Cheng-Chang Chang

Chief of Division

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cheng-Chang Chang, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

China Medical University Hospital

Locations

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Tri-Service General Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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CRF-TSGH02

Identifier Type: -

Identifier Source: org_study_id

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