Effectiveness of electric moxibustion for chronic upper-limb lymphedema in patients with breast cancer: A pilot feasibility study

Not Applicable

Completed

• Conditions: Neoplasms

• Registration Number: KCT0003423
• Lead Sponsor: Dunsan Korean Medicine Hospital of Daejeon University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 18 May 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

(1) Woman over 19 years old who have diagnosed with breast cancer
(2) Subjects who completed primary cancer treatment at least 6 months ago (Hormone therapy can be used in combination)
(3) Subjects with lymphedema in the upper limb of the treated area by breast cancer surgery or radiotherapy
(4) Subjects with lymphedema for at least 6 months and who still have lymphedema
(5) Subjects who has more than 10 mm differences of arm circumference between both upper limbs.
(6) Subjects with Eastern Cooperative Oncology Group (ECOG) performance status below 2 points
(7) Subjects who signed a written agreement

Exclusion Criteria

(1) Subjects who already had lymphedema before breast cancer treatment
(2) Recurred breast cancer, or metastasis of cancer
(3) Subjects with other diseases that can affect edema, such as severe heart failure, kidney failure, cirrhosis
(4) Abnormal liver function test, kidney function test, hepatic or renal function tests (AST, ALT more than twice the upper limit of the normal range, or creatinine is 2.0 mg/dL or more)
(5) Lymphedema accompanied deformed bones, or vascular malformations
(6) HbA1c more than 10%
(7) Platelet count below 60,000/µL, Hemoglobin below 8 g/dL, or Absolute Neutrophil Count(ANC) below 1,000
(8) White blood cell(WBC) above 10,000/µL
(9) Subjects with life expectancy less than 6 months
(10) Subjects plainning to undergo surgery, chemotherapy, and radiation therapy during the trial
(11) Subjects who have been actively treated for improvement of lymphatic edema within the last 4 weeks (Compression stockings, compression bandages etc. are allowed)
(12) Subjects who have participated in other clinical trials within the last 4 weeks
(13) Subjects who had experienced hypersensitivity reactions or serious adverse reactions after moxibustion treatment

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Circumference of upper limbs

Secondary Outcome Measures

Name	Time	Method
Shoulder ROM;Quality of Life;Edema index of upper limbs