KCT0002170
Recruiting
未知
Moxibustion for treating cancer-related fatigue: a multicenter, assessor-blinded, randomized controlled clinical trial
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Symptoms, signs and abnormal clinical and laboratory findings, NEC
- Sponsor
- Korea Institute of Oriental Medicine
- Enrollment
- 96
- Status
- Recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Not specified
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