A Study of the Correlation Between CRF, Survival and Physiological Factors in NSCLC Patients Under Chemotherapy

April 16, 2020 updated by: LJ Hwu, Chung Shan Medical University

An Observational Study of the Correlation Between Cancer-related Fatigue, Survival and Physiological Factors in Non-Small Cell Lung Cancer (NSCLC) Patients Under Chemotherapy

Worldwide, non-small cell lung cancer (NSCLC) is one of the most common causes of cancer mortality. Also, the first leading cause of death is lung cancer in Taiwan 2012. Most patients are diagnosed at advanced stages and their median survival with supportive care is only 3-6 months. The common regimens used on advanced NSCLC treatment consists of platinum-based doublet chemotherapy, the survival benefit of which is able to extend the survival to approximately 10 months. However, disease and treatment-related toxicities in cancer patients may result in fatigue and interfered quality of life (QoL). According to the others reports, eight QoL areas including physical functioning, fatigue, pain, and appetite loss have been showed a statistically significant association with survival rate of NSCLC patients.

Cancer-related fatigue (CRF), an indicator of QoL, has been reported as the most frequent and distressing toxicity of lung cancer chemotherapy. 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.

In addition, electrolyte disturbance like hyponatremia has been reported to be counted as one of the many contributing factors for fatigue in palliative care patients and associated with poorer overall survival rate (OS) in lung cancer. Thus, the correlation between CRF and electrolyte possibly would be a strong link for physician to improve the QoL and survival rate of NSCLC patients.

The objective of this observational study is to evaluate the correlation between CRF, survival and physiological factors in NSCLC patients under chemotherapy. The study will compare the effect of QoL and CRF on survival with or without CRF treatment and investigate the correlation between the variation of CRF and physiological factors which have been examined and recorded on medical record under clinical practice. These results will supply physicians with more understanding about CRF, and help them to enhance the quality on lung cancer care to being perfected in the future.

Study Overview

Status

Unknown

Conditions

Non-small Cell Lung Cancer

Detailed Description

Non-small cell lung cancer (NSCLC) patients with chemotherapy will be enrolled. Patients will be thoroughly informed about all aspects of the study activity schedule and all regulatory requirements that must be satisfied for informed consent. Only patients who give consent to participate in this study and meet all other inclusion and exclusion criteria will be eligible to enroll into this study. ICD-10 fatigue criteria, Brief Fatigue Inventory-Taiwan Form (BFI-T), the visual analog scale (VAS) for appetite and Functional Assessment of Cancer Therapy-General quality of life questionnaire (FACT-G7) will be used to evaluate patients' fatigue and quality of life. Patients who enrolled in this observational study will complete the evaluation and questionnaire of fatigue and quality of life according to clinical schedule. The first survey (baseline) will be collected after enrollment, the further surveys will be completed every three chemotherapy cycles following subject's chemotherapy schedule and after finish the whole course of chemotherapy. Subject demographic and disease-related information and routine laboratory data will also be collected from medical record for analysis.

Study Type

Observational

Enrollment (Anticipated)

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
- - Taichung, Taiwan
    - Recruiting
    - Chung Shan Medical University Hospital
    - Contact:
      
      Shih-Ming Tsao, M.D., Ph.D.
      
      Phone Number: 34711 886-4-24739595
      
      Email: tsmhwy@ms24.hinet.net
    - Principal Investigator:
      
      Shih-Ming Tsao, M.D., Ph.D.

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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Non-small cell lung cancer (NSCLC) patients with chemotherapy

Description

Inclusion Criteria:

Patients who signed the informed consent form.
Aged 20 years and older.
Patients who have been given a diagnosis of stage II-IV NSCLC cancer.
Patients who are under/ or scheduled for chemotherapy treatment.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Patients who are able to complete QoL questionnaires.

Exclusion Criteria:

Patients have enrolled or have not yet completed other investigational drug trials within 30 days before screening.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cancer-related fatigue evaluation by brief fatigue inventory-Taiwanese form (BFI-T) Time Frame: Change from baseline cancer-related fatigue at 6 chemotherapy cycles (24 weeks)	Change from baseline cancer-related fatigue at 6 chemotherapy cycles (24 weeks)

Secondary Outcome Measures

Outcome Measure	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 6 chemotherapy cycles (24 weeks)	Change from baseline quality of life at 6 chemotherapy cycles (24 weeks)

Collaborators and Investigators

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

Sponsor

Chung Shan Medical University

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)

December 22, 2016

Primary Completion (Anticipated)

June 7, 2021

Study Completion (Anticipated)

June 30, 2021

Study Registration Dates

First Submitted

March 26, 2017

First Submitted That Met QC Criteria

April 25, 2017

First Posted (Actual)

April 26, 2017

Study Record Updates

Last Update Posted (Actual)

April 17, 2020

Last Update Submitted That Met QC Criteria

April 16, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

CSMUH01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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.