Breast Neoplasms
Conditions
Interventions
This is a randomized controlled clinical trial with a 1:1 allocation ratio for each group. The intervention aims to utilize compressive bandaging as a form of compressive therapy for the upper limb wi
E02.779
Sponsors
Hospital do Câncer III
Instituto Nacional de Câncer
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Women aged 18 years and older; diagnosed with upper limb lymphedema after 6 months of surgical treatment for breast cancer; in the volume reduction phase, with 10 to 20% excess volume; classified as stage II according to the International Society of Lymphology classification, in which there is the presence of interstitial fibrosis; with or without a lock sign and with mild to moderate volume changes
Exclusion criteria
Exclusion criteria: Women undergoing bilateral lymphadenectomy or with bilateral lymphedema; lymphedema since the preoperative period; presence of phlogistic signs in the edematous limb; with lesions with loss of continuity in the skin of the limb with lymphedema; previous history of allergic reaction to the material used for compression therapy; active locoregional or distant disease; undergoing chemotherapy or radiotherapy; those with functional changes in the upper limbs prior to the diagnosis of breast cancer; those with heart disease and decompensated systemic arterial hypertension; psychiatric, mental, neurological disorders or cognitive deficits that make it impossible for them to answer the questionnaires
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lymphedema arm volume: This will be evaluated by determining upper limb perimetry, with reference to the cubital fold, from which points will be measured at 7 cm, 14 cm, and 21 cm below and 7 cm and 14 cm above. The measurements referring to each point will be applied in the trunk cone formula V = h * (C2 + Cc + c2)/(p* 12), where V is the limb segment volume, C and c are the circumferences at each end, and h is the distance between circles (C). This calculation will represent the estimated limb volume. The limb volume percentage reduction will be calculated as (VI-VF/VI)*100, where VI comprises the initial volume and VF the final volume. The treatment response will be considered effective when an affected upper limb volume reduction of over 10% of the initial volume takes place. | — |
Secondary
| Measure | Time frame |
|---|---|
| Health-related QoL: The health-related QoL will be assessed by using two European Organization for Research and Treatment of Cancer (EORTC) questionnaires: Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and Quality of Life Questionnaire breast cancer-specific (EORTC QLQ-BR 23). Both questionnaires have been translated into Portuguese and validated for the Brazilian population.;Sleep quality (SQ): Refers to the subject's subjective perception of their sleep-wake cycle. Because cancer patients frequently experience sleep disorders (change in the sleep-wake cycle) especially when they are elderly. It will be evaluated by the Pittsburgh Sleep Quality Index (PSQI), translated and validated for Brazilians.;Upper limb functionality: Upper limb functionality will be evaluated by the Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH), translated into Portuguese and both validated and adapted for the Brazilian population.;Subjective symptoms: the presence of pain, itching, discomfort (tightness/stiffness) and sensation of heaviness will be assessed, using the visual numerical scale (VNS). These symptoms will be noted in the therapeutic diary during the first 30 days of treatment.;Satisfaction with treatment: Assessed by the Satisfaction Questionnaire on Textile Therapeutic Devices for Lymphedema Secondary to Breast Cancer Treatment (QS-DTT-LSCM) - recently translated, adapted and validated for the Brazilian population. Composed of four dimensions: emotional, patient comfort, patient adherence and benefits, with a total score ranging from 20 to 100 points, with a lower score reflecting greater satisfaction with the device.;Adherence to treatment: In order to check adherence, the therapeutic diary resource will be used. Accounting for the use of therapy (adherence to compression therapy) and daily skin care associated with exercises with compression therapy (adherence to the lymphedema self-management strategy) during the initial 30 days. Considering poor ad | — |
Countries
Brazil
Contacts
Public ContactAnke Bergmann
Instituto Nacional de Câncer
Outcome results
None listed