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Preliminary study on efficacy and safety of Kyung-Ok-Ko on cancer fatigue in lung cancer patients during cancer treatment

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0003666
Enrollment
50
Registered
2019-03-25
Start date
2019-02-08
Completion date
Unknown
Last updated
2019-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Experimental group: Kyung-Ok-Ko Usage: twice a day, after 1-hour each meal Dosage: 23.5g/1 stick, 47g/day Administration: Oral Duration: 6-weak Placebo group: Placebo Kyung-Ok-Ko Placebo is s

Sponsors

Kyung Hee University Oriental Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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 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

Design outcomes

Primary

MeasureTime frame
Brief Fatigue Inventory

Secondary

MeasureTime frame
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

Countries

Korea, Republic of

Contacts

Public ContactSeung a ko

Kyung Hee University Hospital

rhelddj7@hanmail.net+82-2-958-9103

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026