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

July 3, 2024 updated by: 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. 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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

53

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Tri-Service General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Gynecologic cancer patients
Gynecologic cancer patients under chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer-related fatigue evaluation by brief fatigue inventory-Taiwanese form(BFI-T)
Time Frame: 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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life assessments by functional assessment of cancer therapy-general 7 (FACT-G7)
Time Frame: 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)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cytokine and immune markers
Time Frame: 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tri-Service General Hospital

Investigators

  • Principal Investigator: Cheng-Chang Chang, M.D., Ph.D., China Medical University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2016

Primary Completion (Actual)

March 4, 2022

Study Completion (Actual)

March 4, 2022

Study Registration Dates

First Submitted

March 20, 2017

First Submitted That Met QC Criteria

March 20, 2017

First Posted (Actual)

March 24, 2017

Study Record Updates

Last Update Posted (Actual)

July 5, 2024

Last Update Submitted That Met QC Criteria

July 3, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRF-TSGH02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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