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Lymphedema Prevention After Lymph Node Emptying

NCT04785599 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2021-03-08

No results posted yet for this study

Summary

ABSTRACT Object: The impact of morbidity and the deterioration in health-related quality of life for patients with lymphedema after axillary lymph node dissection for breast cancer justify the implementation of prevention programs to decrease the incidence of this chronic condition. The aim was to compare the effectiveness of an experimental prevention program with that of our conventional prevention program.

Methods: Clinical randomized trial in two parallel groups over a two-year period.

Key words: lymphedema, breast cancer, prevention, rehabilitation

Conditions

Interventions

BEHAVIORAL

Exercices

An exercise program. Seven days after lymph node removal, participants began this program at the physiotherapy department. They attended two weekly sessions of 60 minutes each. The sessions at the centre continued for 12 weeks. The program consisted of aerobic exercise, in combination with resistance and stretching exercises.

BEHAVIORAL

Informative talk

An informative talk: Patients attended a one-hour long talk about lymphedema. The topics covered were a description of the condition, the risks, and preventive measures to include in their daily life. The recommended measures were those from the general consensus of the International Lymphedema Society, the Spanish Rehabilitation Society and The National Breast and Ovarian Cancer Center

DEVICE

Compression garment

Wearing a flat knit compression garment (CG), class 1. Participants were recommended to wear this CG for an average of 8 hours during the daytime for the first 3 months after surgery, and to remove it at night. From the fourth month onwards, use of the garment was reduced to 2 hours a day, coinciding with exercises and physical activity.

Sponsors & Collaborators

  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    lead OTHER

Principal Investigators

  • Maria José Nadal Castells, PhD · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-03
Primary Completion
2011-10-03
Completion
2015-04-13

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04785599 on ClinicalTrials.gov