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Moxibustion for Treating Cancer-related fatigue

Not Applicable
Conditions
Neoplasms
Registration Number
KCT0000918
Lead Sponsor
Korea Institute of Oriental Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot yet recruiting
Sex
All
Target Recruitment
30
Inclusion Criteria

1. Both male and female, 19 years of age and older with a diagnosis of cancer
2. Had completed 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
3. A score = 4 on the Brief Fatigue Inventory (BFI) at least 4 weeks before the randomization
4. A score = 2 on the Eastern Cooperative Oncology Group (ECOG) performance status

Exclusion Criteria

1. A platelet count less than 50,000/ µL, Hemoglobin less than 9g/d, Hematocrit less than 30%;
2. Receiving aggressive treatment for anemia (e.g. erythropoietin or blood transfusion);
3. A score = 11 on HADS (Hospital Anxiety and Depression Scale);
4. Taking medicine for depression;
5. A score = 4 on the Numeric rating scale(NRS) for cancer pain
6. ANC (Absolute neutrophil count) = 1,000;
7. Had similar fatigue prior to diagnosis of cancer
8. Had an anticipated survival rate of less than six months
9. Have a plan of surgery, chemotherapy, radiotherapy during the study
10. Medication (e.g. stimulant) or Korean medical treatment (e.g. acupuncture, moxibustion, cupping or herbal medicine) for cancer-related fatigue used within the past two weeks
11. Have a new plan of change of chronic medications or initiation of dietary supplements or non-phamacologic therapy (e.g. exercise, meditation, cognitive behavioral therapy etc.) during the study
12. Known hypersensitivity reactions or severe adverse events after moxibustion treatment or an inability to cooperate with moxibustion treatment by some reasons, especially difficulty in breathing.
13.Pregnancy, planning a pregnancy or breast-feeding
14. In the case that researcher determined participants are inappropriate in clinical trial in the light of clincal symptoms or blood test

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Brief fatigue inventory (BFI)
Secondary Outcome Measures
NameTimeMethod
Brief fatigue inventory (BFI);Fatigue Questionnaire (FQ);Functional Assessment of Cancer Therapy-Fatigue (FACT-F) ;Hospital Anxiety and Depression Scale (HADS);Pittsburgh Sleep Quality Index (PSQI);EORTC QLQ-C30;Days of restricted activity;Patients' Global Impression of Change (PGIC) ;Serum immunological, oxidative and antioxidative marker;Adverse events
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