Purpose: The purpose of this study is to identify the efficacy and safety of Kyung-Ok-Ko that has been clinically used.

Background: Cancer fatigue refers to fatigue in cancer patients receiving cancer treatment, where "fatigue means a subjective feeling of being tired, weakened or lacking energy”. Cancer fatigue is a major symptom among   that many cancer patients experience when receiving chemotherapy and radiation therapy. Because it has a multidimensional influence on cancer patients, they may experience physical weakening, decline in cognitive function due to deteriorating mental strength, and depression from emotional impacts. Kyung-Ok-Ko  is used for improving fatigue or weak constitution. It is known to be effective in immune activation, anti-fatigue, and enhancing cognitive function. Therefore we aim to investigate the efficacy and safety of kyungokgo that has been clinically used.
 
This is a randomized, placebo controlled, double blind, parallel, single center preliminary clinical trial designed to evaluate the efficacy and safety of kyungokgo that is used in patients with lung cancer who received cancer treatment (chemotherapy and radiation therapy) to improve cancer fatigue after therapy. The trial is conducted for a total of 10 weeks, as patients who experience cancer fatigue two weeks after completing cancer treatment receive 6 weeks of the clinical trial drug, followed by a 4-week observation period. The fifty subjects will be recruited and assigned to the experimental group and the control group at 1:1 ratio. Experimental group administers Kyung-Ok-Ko, which is a semi-solid formulation with a dark brown viscosity of 23.5g per package, twice a day for a total of six weeks. Placebo group administers placebo Kyung-Ok-Ko, which is 23.5g per package, twice a day for a total of six weeks.

Treatment

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 similar to Kyung-Ok-Ko in flavor, scent, and color without key ingredients detected. Placebo is composed of glucose, sucrose, lactose, corn starch, D-sorbitol, xanthan gum, caramel color, etc. Usage, dosage, administration and duration of administration are same as experimental group.

Arm Label

Target Number of Participant

Arm Type

Arm Description

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

Arm Label

Target Number of Participant

Arm Type

Arm Description

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

Gender

Age

Description

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

Brief Fatigue Inventory

baseline, 2-week, 4-week, 6-week, 10-week

Fatigue measure tool (Visual Analogue Scale, Functional Assessment of Chronic Illness Therapy fatigue scale)

baseline, 2-week, 4-week, 6-week, 10-week

Depression outcome measure (Hospital Anxiety Depression Scale, HADS)

baseline,6-week, 10-week

Pulmonary test (Pulmonary function test, 6 minite walk test)

baseline, 6-week

Cognitive impairment measure (Montreal Cognitive Assessment Korean version, MoCA-K)

baseline,6-week, 10-week

Korean pattern identification questionnaire

baseline,6-week, 10-week