Moxibustion for the Treatment of Lymphedema in women who have Breast Cancer Surgery
- Conditions
- MastectomyC04.588.180Breast Cancer Lymphedema
- Registration Number
- RBR-9wkgdxp
- Lead Sponsor
- Faculdade de Enfermagem Nossa Senhora das Graças da Universidade de Pernambuco
- Brief Summary
The objective was to evaluate the effect of moxibustion as an adjuvant therapy in the control of lymphedema in women with mastectomies. This is an intervention study, carried out at the Hospital do Câncer de Pernambuco during August 2021 and July 2022. Its target audience was women aged =30 years, with lymphedema related to the treatment of unilateral breast cancer and who attended the outpatient clinic to perform compressive bandaging and manual lymphatic drainage. Participants were divided into two groups using a random technique and stratified by clusters, where women who attended the outpatient clinic on Mondays and Wednesdays in the morning would make up the intervention group, and those who attended on Tuesdays and Thursdays in the afternoon, the control group. All participants were assessed for the degree of lymphedema, and the perimetry of the upper limbs was recorded at five points. The intervention group was offered (in addition to the standard treatment) eight moxibustion sessions that took place in four weeks with a maximum duration of 20 minutes, while the control group followed only the standard treatment of the institution. Finally, after the intervention period, the lymphedema was again evaluated and the Effective Index for Upper-limb Lymphedema was calculated to determine the progression or regression of the condition. The normality and homogeneity of data variance were evaluated using the Shapiro-Wilk and Levene tests, respectively. Generalized estimation equation models were used considering time (pre vs. post) and group (intervention vs. control) factors. When there was statistical significance for interaction, Bonferroni's post-hoc was used in order to identify where differences occurred. The team members responsible for assessing lymphedema were blinded during the survey, as well as the statistician responsible for data analysis and shift randomization. Resolution 466/2012 of the National Health Council of the Ministry of Health was complied with, receiving a favorable assessment from the Research Ethics Committee of the Hospital do Câncer, with Opinion Number: 4,849,199. In all, 28 women participated in the study, 14 in the intervention group and 14 in the control group. The mean age was 58.9 years, most of whom were non-white, with a low level of education. As for clinical data, the expressive majority were overweight and had undergone mastectomy, with an average of 11.9 lymph nodes removed (±7.8). Women who removed more than 12 lymph nodes had greater perimetry in the region corresponding to 7 cm below the elbow line. Regarding the Effective Index for Upper-limb Lymphedema, the intervention group had an improvement of 23.0% after treatment with moxibustion, while the control group improved by 5.3% (p=0.016). It is concluded that moxibustion presented satisfactory results for the reduction of lymphedema in women submitted to mastectomies due to breast cancer. A simple, low-cost and easy-to-perform therapy can contribute to the management of iatrogenesis, but it is admitted that there are still barriers for complementary therapies to be accepted in the hegemonic models of modern medicine. More studies are needed to prove its efficacy and safety, exploring more plural populations that guarantee the extrapolation of results.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruitment completed
- Sex
- Female
- Target Recruitment
- Not specified
Women aged 30 years or older, diagnosed with breast cancer and who underwent unilateral mastectomy at least six months ago, allowing comparison between the two limbs; Undergoing neoadjuvant and/or adjuvant radiotherapy and chemotherapy, which may increase the risk of developing lymphedema; Proof of lymphedema through perimetry of the affected arm =3 cm than that of the contralateral arm.
Diseases related to the vascular system, coagulopathies, skin infections or any condition that contraindicates moxibustion; Limb skin trauma, ulceration or skin disease, as such conditions can hinder venous and lymphatic return; Patients who have breathing problems (allergy to subtle smells), since they can be aggravated by the technique; Women who are receiving other treatments for lymphedema other than those established by the service, in order to guarantee homogeneity in the therapeutic protocol and allow comparisons; Previous contact with any modality of moxibustion, as it will make it impossible for the participant to be blinded; Pregnancy, as there is controversy regarding the safety of moxa in early pregnancy.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Expected outcome 1: An Effective Index for Upper-Limb Lymphedema value equal to or greater than 20% is expected.;Outcome found 1: An Effective Index for Upper-Limb Lymphedema of 23.0% was observed in the intervention group, and only 5.3% in the control group, with a value of p=0.016 (derived from the Man Whitney U test).
- Secondary Outcome Measures
Name Time Method Secondary outcomes were not expected.