Lymphedema Prevention in Breast Cancer

University of Alcala

Status: Completed

Conditions: BREAST CANCER; LYMPHEDEMA

Treatments: Other: Early Physical Therapy and Educational strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT00760123

ID1124

Details and patient eligibility

About

OBJECTIVE: To find out the effectiveness of early application of physical therapy in the prevention of lymphedema after breast surgery and lymphadenectomy.

DESIGN: Randomized, controlled and single blinded clinical trial. Three years duration. Patients will be randomly assigned to one of these groups: Experimental group: Early physical therapy + training in means of prevention; Control group: just training in means of prevention. In both groups several physical therapy assessments will be undertaken: 1st before surgery; 2nd immediately after surgery; 3rd after completing intervention; 4th, 5th and 6th after 3, 6, 12 and 24 months.

SUBJECTS: Women with breast cancer treated with breast surgery including lymphadenectomy in Principe de Asturias Hospital, provided that there is no contraindication for physical therapy, and after reading, understanding and freely signing an informed consent form.

SAMPLE SIZE: A total of 116 subjects will be included in the study (58 subjects in each group), assuming a 15% of drop-outs and at least 20% reduction, with a statistical power of 60%.

DATA ANALYSIS: To find out the effectiveness of intervention we will compare the rate of lymphedema in both groups by means of a logistic regression analysis, in which the main factor is the intervention group. Other factors aimed to control the effect of the intervention will also be included. In order to compare the rate of appearance of lymphedema in both groups, a survival analysis will also be included.

Enrollment: 120 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Consecutive women diagnosed with breast cancer and undergoing unilateral surgery with axillary lymph-node dissection at the Príncipe de Asturias Hospital in Alcalá de Henares, Madrid (Spain) are candidates for inclusion in the study.

Exclusion criteria

• Patients without axillary lymph-node dissection or with bilateral BC, systemic disease, locoregional recurrence, or any contraindication to physical therapy are excluded from the study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

1

Experimental group

Description:

Early Physical Therapy including a manual lymph-drainage technique, progressive massage of the scar, and progressive active and action-assisted shoulder exercises started in conjunction with functional activities and proprioceptive neuromuscular facilitation without resistance and educational strategy including instruction with printed materials about the lymphatic system, concepts of normal load versus overload, lymphedema source, the identification of possible precipitating factors, etc.

Treatment:

Other: Early Physical Therapy and Educational strategy

2

Other group

Description:

Educational Strategy: instruction with printed materials about the lymphatic system, concepts of normal load versus overload, lymphedema source, the identification of possible precipitating factors, etc.

Treatment:

Other: Early Physical Therapy and Educational strategy