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Electronic Moxibustion for Breast Cancer-Related Lymphedema: A Pilot Clinical Trial

ABSTRACT: This is a preliminary study to investigate the feasibility of electronic moxibustion in breast cancer patients with upper limb lymphedema. As current treatment options for lymphedema are unsatisfactory and time consuming, there have been attempts to manage symptoms using integrative treatments. Electronic moxibustion was developed to compensate for the shortcomings of conventional moxibustion and is widely used in clinical practice. However, there have been no studies on using electronic moxibustion in breast cancer-related lymphedema. To investigate the feasibility of electronic moxibustion in treating breast cancer-related lymphedema, this study included subjects who completed primary cancer treatment at least 6?months ago and had more than 10?mm difference in arm circumference of upper limbs. All subjects were assigned to the treatment group. Subjects were treated with 16 sessions (30?minutes/session) of electronic moxibustion for 8?weeks followed by 4?weeks of follow-up. For outcome measures, upper limb circumferences, shoulder range of motion, bioimpedance analysis, and quality of life questionnaire were assessed. All 10 subjects completed the study. The effective index showed 38.21% reduction after treatment (P?=?.0098) and 29.35% (P?=?.0039) after 4?weeks of follow-up compared to the baseline. The reduction of lymphedema was most prominent at 10?cm above the elbow crease, where the mean reduction of circumference difference was 7.5?mm (P?=?.0430) and continued to improve after treatment (mean reduction of 8.3?mm, P?=?.0156). There was significant improvement in shoulder range of motion only in flexion and internal rotation at week 9. There were 7 adverse events, and most were irrelevant to the treatment. Only 1 participant had a mild burn on the acupuncture point. Here, we demonstrate for the first time that electronic moxibustion treatment is a feasible treatment for breast cancer-related lymphedema. Electronic moxibustion may reduce differences in upper limb circumference and improve shoulder range of motion. A future comparative clinical trial is needed to confirm the clinical efficacy of this treatment.

SUBMITTER: Han K

PROVIDER: S-EPMC7570305 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Project description:ObjectiveThe aim of this systematic review and meta-analysis of randomized controlled trials (RCTs) was to evaluate the effects of acupuncture and moxibustion (AM) in women with breast cancer-related lymphedema (BCRL).MethodsWe retrieved RCTs published before January 24, 2021, from the MEDLINE, EMBASE, Cochrane Library, Web of Science, China National Knowledge Infrastructure (CNKI), Chongqing VIP (VIP), and Wanfang databases. RCTs that compared acupuncture and/or moxibustion intervention with other treatments were included. A random effects or fixed effects model was used based on the heterogeneity findings. Study quality was evaluated using the Cochrane risk of bias tool.ResultsWe included 14 RCTs in the analyses, of which 4 RCTs adopted acupuncture, 4 RCTs used moxibustion, and the rest used both. AM significantly reduced arm circumference at the elbow crease compared to routine care (Mean deviation (MD) = -7.26, 95% confidence interval (CI) = -8.30 to -6.21, P < .00001). There was a significant difference between AM and diosmin tablets in the effective index for upper limb lymphedema (MD = 24.68, 95% CI = 24.82-30.53, P < .00001), the range of motion of the shoulder during protraction (MD = 6.77, 95% CI = 2.81-10.73, P = .0008), and adduction (MD = 4.17, 95% CI = 1.02-7.32, P = .01). There was a significant difference between moxibustion and pneumatic circulation (MD = -0.51, 95% CI = -0.85 to -0.17, P = .003) in the visual analog score (VAS) for swelling. Finally, compared to the blank control, acupuncture reduced the VAS for pain (MD = -1.33, 95% CI = -1.52 to -1.15, P < .00001; heterogeneity (I2) = 0%, P = .57).ConclusionOur results suggest that AM is effective in the treatment of BCRL. AM may reduce arm circumference at the elbow crease (compared to routine care), increase effective index for upper limb lymphedema (compared to oral diosmin tablets), improve the range of motion of the shoulder during protraction and adduction (compared to oral diosmin tablets), and decrease the VAS for both swelling (compared to pneumatic circulation) and pain (compared to blank control).

Project description:PurposeBreast cancer-related lymphedema (BCRL) is a chronic, progressive side effect of breast cancer treatment, occurring in one-third of patients treated with axillary lymph node dissection and nodal radiotherapy. Cluster of differentiation 4-positive (CD4+) cells plays a key role in BCRL by facilitating inflammation and inhibiting lymphangiogenesis. Tacrolimus is an anti-inflammatory and immunosuppressive macrolide that targets CD4+ cells. Treatment of lymphedema with topical tacrolimus has revealed promising results in preclinical trials. This clinical trial was aimed at evaluating the feasibility, safety, and effect of tacrolimus in women with stage I or II BCRL, according to the International Society of Lymphology.MethodsWe conducted this open-label, single-arm, phase II pilot trial from September 2020 to April 2021. Eighteen women with BCRL stage I or II BCRL were treated with topical tacrolimus for 6 months and followed up at 3 and 6 months. The primary outcome was arm volume, and secondary outcomes were the lymphedema index (L-Dex), health-related quality of life (HRQoL), lymph flow and function, and safety and feasibility of the trial design.ResultsThe mean lymphedema arm volume and L-Dex reduced significantly by 130.44 ± 210.13 mL (p < 0.05; relative reduction: 3.6%) and 3.54 ± 4.98 (p < 0.05), respectively, and health-related quality of life scores was improved significantly (p < 0.05). According to the MD Anderson scale, in terms of lymph flow and function, three patients (16.7%) showed improvement, while none showed worsening. Lymph flow or function showed no change according to the Arm Dermal Backflow scale.ConclusionIn this trial, treatment with tacrolimus was safe and feasible in women with stage I or II BCRL. Tacrolimus alleviated BCRL in terms of improved arm volume, L-Dex, and HRQoL. Assessments of lymph flow and function were positive, although inconclusive. Larger randomized controlled trials are required to verify these findings.Trial registrationClinicalTrials.gov Identifier: NCT04541290.

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Electronic Moxibustion for Breast Cancer-Related Lymphedema: A Pilot Clinical Trial

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