Preliminary study on efficacy and safety of Kyung-Ok-Ko on cancer fatigue in lung cancer patients during cancer treatment
- Conditions
- Neoplasms
- Registration Number
- KCT0003666
- Lead Sponsor
- Kyung Hee University Oriental Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
1) Men and women aged 19-75 years old
2) Lung cancer patients who received cancer treatment (Chemo and radiation therapy)
3) Patients who have completed cancer treatment over 2 weeks ago and do not have further cancer treatment plan
4) Patients experiencing fatigue with BFI >4
5) Patients with Eastern Cooperative Oncology Group (ECOG) scale <2
6) Patients who voluntarily decided to participate in this clinical trial and signed the consent form
1) Patients suspected of relapse or progression according to chest CT or Chest Xray
2) Patients with anemia with hemoglobin level <9 g/dL, or platelets <50 000/mL, or absolute neutrophil with count <1000/mL
3) Patients with uncontrolled thyroid disorder (hyperthyroidism fT4 > 1.79 ng/dL, hypothyroidism Thyroid Stimulating Hormone > 10?/dL)
4) Patients with moderate liver and kidney impairment (increase in AST and ALT by more than 3 times, or increase in creatinine by more than 2 times)
5) Patients who do not expect more than 6 months of life expectancy for cancer diagnosis
6) Patients diagnosed and treated for severe dementia (MoCA < 10), severe depression (HADS >15)
7) Patients who are deemed difficult to perform clinical trial
8) Early stage lung cancer patients who are treated with surgery alone and late stage lung cancer patients who are not receiving cancer treatment
9) Patients who received oriental medicine or pharmacotherapy (methylphenidate, modafinil, bupropion) for the purpose of improving cancer fatigue in the last 4 weeks
10) Patients who are pregnant or breastfeeding
11) Patients who did not agree to contraception during the clinical trial period
12) Patients who participated in a clinical trial for the same disease in the last 3 months
13) Patients who are not eligible to participate in this trial at the discretion of the investigator
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Brief Fatigue Inventory
- Secondary Outcome Measures
Name Time Method Fatigue measure tool (Visual Analogue Scale, Functional Assessment of Chronic Illness Therapy fatigue scale);Depression outcome measure (Hospital Anxiety Depression Scale, HADS);Pulmonary test (Pulmonary function test, 6 minite walk test);Cognitive impairment measure (Montreal Cognitive Assessment Korean version, MoCA-K);Korean pattern identification questionnaire