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

Safety, effectiveness, and economic evaluation of adjuvant moxibustion therapy for aromataseinhibitor (AI)-induced arthralgia of postmenopausal breast cancer stage ?–? patients: a prospective, randomized, assessor-blind, usual-care controlled, parallel-group, pilot clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0003698
Enrollment
46
Registered
2019-04-01
Start date
2019-07-01
Completion date
Unknown
Last updated
2019-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device, Others : Moxibustion therapy: Conical shaped moxibustion (approximately 2 cm of diameter in the base side and 1.5 cm of height), made of mugwort, will be applied on the 6 to 10 acupoin

Sponsors

Kyung Hee University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Brief Pain Inventory – Short Form (BPI-SF)

Secondary

MeasureTime frame
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

Countries

Korea, Republic of

Contacts

Public ContactDeok-Sang Hwang

Kyung Hee University Oriental Medical Center

soulhus@gmail.com+82-2-958-9160

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026