Clinical trial NCT04785599: Lymphedema Prevention After Lymph Node Emptying
Official title: Effectiveness of Lymphedema Prevention Programs After Lymph Node Emptying in Breast Cancer: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema
Breast Cancer
Prevention
Rehabilitation
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

Detailed description: This was a single-centre, open-label, controlled, randomized clinical trial. Patients were recruited from the Breast Pathology Unit at Hospital de la Santa Creu i Sant Pau (HSCSP), a tertiary referral hospital in Barcelona between March 2011 and April 2013. The inclusion criteria were as follows:

* Patients between 18 and 85 years
* Having undergone a lymph node dissection as part of treatment for primary breast neoplasm
* Acceptance of the study conditions and signing of the informed consent

Exclusion criteria were:

* tumour recurrences
* metastatic cancer
* open wounds or loss of skin integrity
* dependency or deterioration of higher functions
* arterial insufficiency and deep vein thrombosis
* acute heart failure
* severe peripheral neuropathy
* lymphedema Patients included in the study were randomized to one of two groups. Group 1(G1) carried out the conventional prevention program consisting of an informative talk and an exercise program. Group 2(G2) carried out the same program but with the addition of a prophylactic compression garment.

The program common to both groups consisted of:

1. 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 (J.González-Sánchez y Sánchez- Mata F 2010) (See tables 1 and 2).
2. 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.

Group 2 (experimental) was also prescribed:

• 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.

The study was evaluated and authorized by the Ethics Committee at Hospital de la Santa Creu i Sant Pau (HSCSP), code IIBS-EPC-2011-87. All patients signed the written informed consent form.

Evaluations All patients were evaluated at the start of the study, at the end of the exercise prevention program, at 6 months, and at one and two years.

In all the evaluations, we measured the volume of the upper extremities following the lymphedema calculation formula based on the truncated cone, validated and published by the Spanish Society of Physical Medicine and Rehabilitation (SERMEF).

Lymphedema was defined as a difference of more than 200 ml in volume between the upper extremities, or as a difference of 10% in volume between the two upper limbs (SERMEF 2012).

We recorded all the parameters of the history and general clinical examination, TNM stage, performed treatments, number of resected nodes and complications. Compliance with all the components of each program was monitored. Data regarding presence at the talk and at the exercise program sessions at the centre were recorded by calendar. Home compliance was monitored through personal interviews at 6 months, 1 year and 2 years.

Eligibility criteria: Inclusion Criteria:

* Having undergone a lymph node dissection as part of treatment for primary breast neoplasm
* Acceptance of the study conditions and signing of the informed consent

Exclusion Criteria:

* Tumour recurrences
* Metastatic cancer
* Open wounds or loss of skin integrity
* Dependency or deterioration of higher functions
* Arterial insufficiency and deep vein thrombosis
* Acute heart failure
* Severe peripheral neuropathy
* Lymphedema

Primary outcomes:
measure: Measure of arms volume
timeFrame: All patients were evaluated at the start of the study
measure: Measure of arms volume
timeFrame: All patients were evaluated at 3 months from beginning
Secondary outcomes:
Other outcomes:
measure: Measure of arms volume
timeFrame: All patients were evaluated at 6 months from beginning
measure: Measure of arms volume
timeFrame: All patients were evaluated at 12 months from beginning
measure: Measure of arms volume
timeFrame: All patients were evaluated at 24 months from beginning
Locations:
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Maria José Nadal Castells, PhD
role: PRINCIPAL_INVESTIGATOR
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