Treatment study of Breast Cancer related Lymphedema

Phase 3

Conditions: Breast Neoplasms
C15.604.496.160

Registration Number: RBR-3sp77cq

Lead Sponsor: Hospital do Câncer III

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: Female

Target Recruitment: Not specified

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

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

Study & Design

Study Type: Intervention

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ymphedema 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 Outcome Measures