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Effect of moxibustion therapy for aromataseinhibitor-induced arthralgia of postmenopausal breast cancer patients

Not Applicable
Conditions
Neoplasms
Registration Number
KCT0003698
Lead Sponsor
Kyung Hee University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot yet recruiting
Sex
Female
Target Recruitment
46
Inclusion Criteria

1) Female, aged 45 to 65, who have missed menstrual periods in a row for at least 1 year (amenorrhea) or is showing 45mIU/mL or higher of serum follicle-stimulating hormone
2) Estrogen receptor positive breast cancer patients of stage I to III, who have completed surgical procedures, chemotherapy, and/or radiation therapy and planned no more active treatments
3) Patients who have been taking the 3rd generation aromatase inhibitors (anastrozole, letrozole, etc.) for 3 months or more and plan to continue the oral administration while participating in this study
4) Patients who are complaining arthralgia in one or more joints, newly developed after the administration of the aromatase inhibitors
5) 4 points or higher of the maximum pain level, assessed with Brief Pain Inventory-Short Form at screening assessment
6) Volunteers who signed the informed consent forms

Exclusion Criteria

1) Primary/metastatic residual cancer or recurrent cancer
2) History of fracture or surgery in the joints where the pain exists within 3 months
3) History of moxibustion therapy in the joints with aromatase inhibitor-induced arthralgia within 3 months
4) Present administration of steroid/narcotic analgesics
5) History of allergy to moxibustion or keloid, presence of skin diseases on body parts for moxibustion therapy
6) Refusal to therapy due to moxibustion fear
7) Participation in another clinical study within 1 month
8) Any other inappropriate reasons to participate in the study, judged by the investigators

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Brief Pain Inventory – Short Form (BPI-SF)
Secondary Outcome Measures
NameTimeMethod
Beck Depression Inventory (BDI);Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF);Functional Assessment of Cancer Therapy–Breast (FACT-B);Amounts of acetaminophen administration;Institute for Medical Technology Assessment Productivity Cost Questionnaire;Work Productivity and Activity Impairment Questionnaire (WPAI);Cost survey;Adverse events;EuroQoL Five Dimensions questionnaire
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