This study is a randomized, controlled, multicenter clinical trial to assess the effectiveness and safety of moxibustion treatment for treating cancer-related fatigue in patients with cancer.

Treatment

Participants will be randomly assigned to one of the three groups: moxibustion treatment, sham moxibustion, or usual care group.
The two former groups will receive moxibustion treatment twice a week during a 8-week period, while the usual care group will not. All the three groups will be educated with a brochure about the cancer-related fatigue. 

Arm Label

Target Number of Participant

Arm Type

Arm Description

The moxibustion treatment group will receive 16 sessions of moxibustion treatment at four acupoints (CV12, CV8, bilateral  LI4 and ST36) twice a week for 8 weeks.

Arm Label

Target Number of Participant

Arm Type

Arm Description

The placebo sham moxibustion devices that appear to be the same as the real mosibustions but generate low heat below appropriate treatment temparature will be applied at non-acupoints on abdomen and four limbs. Everything else will be the same as that for treatment group.

Arm Label

Target Number of Participant

Arm Type

Arm Description

The usual care group can maintain the usual treatment and self care, but cannot begin additional treatment to improve their cancer-related fatigue during the study.

Gender

Age

Description

1. Both male and female, aged 19 or over, but under 80 years
2. Cessation of cancer-related treatments (e.g. surgery, chemotherapy, radiotherapy, immunotherapy, except for on-going hormone therapy, which must have been initiated at least 3 weeks prior to enrollment) at least 12 weeks before the trial
3. Continuous fatigue related to cancer treatment or cancer itself for at least 4 weeks, fulfilment of The International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnostic criteria for cancer-related fatigue, and 4 and higher points in a Brief Fatigue Inventory (BFI) score
4. The Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
5. Willingness to participate in the trial and provide written consent

1. Current level of fatigue even before the diagnosis of cancer
2. Severe anemia (platelet count < 60,000/μL, or hemoglobin < 8 g/dL, or absolute neutrophil count < 1,000)
3. Receiving aggressive treatment for anemia (e.g. erythropoietin or blood transfusion)
4. Poor oral intake with a lower-than-normal level of serum albumin 
5. Any significant sign or symptom of inflammation with C-reactive protein ≥ 10 mg/L and white blood cell > 10,000/μL 
6. Abnormal findings in thyroid function test (abnormal level of Free thyroxine [free T4] and thyroid stimulating hormone [TSH] < 0.1 uIU/ml or TSH > 5.1 uIU/ml)
7. Abnormal findings in liver function test or renal function test, or serious liver failure or renal failure
(aspartate aminotransferase or alanine aminotransferase ≥ 2 x upper normal range, or creatinine ≥ 2.0 mg/dL)
8. A score of 11 points and over in subscale of anxiety or depression in Hospital Anxiety and Depression Scale (HADS)
9. A score of 15 points and over in insomnia severity index (ISI)
10. Level of cancer pain measured by numeric rating scale ≥ 4
11. Six months or less life expectancy
12. A plan of surgery, chemotherapy, radiotherapy during the study
13. Past history of medication (methylphenidate, modafinil, bupropion, dexamethasone) to manage cancer-related fatigue at least 4 weeks before the trial 
14. Past history of Korean medical treatment (e.g. acupuncture, moxibustion, cupping, or herbal medicine, etc.) to manage cancer-related fatigue at least 4 weeks before the trial
15. Past history in the preivous 4 weeks or a new plan during the study of initiating dietary supplements or non-pharmacologic therapies (e.g. cognitive behavioral therapy, exercise etc.) to alleviate cancer-related fatigue
16. Having participated in other clinical trial in the precious 4 weeks
17. Past history of hypersensitivity reactions or serious adverse reactions after moxibustion treatment or an inability to cooperate with moxibustion treatment due to some reasons such as dyspnea
18. Women who are pregnant, lactating, or planning to become pregnant
19. Presence of other apparent factors or any diseases that could cause the current fatigue other than cancer treatment or cancer itself

Mean change of total scores in the Brief fatigue inventory (BFI)

At baseline, 9th week after randomization 

Mean change of total scores in the BFI

5th and 13th week after randomization 

Mean change of total scores in the Functional Assessment of Cancer Therapy-Fatigue (FACT-F) 

At baseline, after randomization (before treatment), 5th, 9th and 13th week after randomization 

Mean change of total scores in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

At basline, 9th and 13th week after randomization 

Mean change of total scores in the Korean version of Montreal Cognitive Assessment (MoCA-K)

At basline, 9th week after randomization 

Adverse event

Every visit

Blinding test

After first treatment, 9th week after randomization (after finial treatment)

Credibility questionnaire

After first treatment, 9th week after randomization (after finial treatment)