KCT0003666
Recruiting
未知
Preliminary study on efficacy and safety of Kyung-Ok-Ko on cancer fatigue in lung cancer patients during cancer treatment - randomized, double blind, placebo controlled, parallel, single center investigator clinical trial
Kyung Hee University Oriental Medical Center0 sites50 target enrollmentTBD
ConditionsNeoplasms
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- Kyung Hee University Oriental Medical Center
- Enrollment
- 50
- Status
- Recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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