Clinical trial NCT00760123: Lymphedema Prevention in Breast Cancer
Official title: Lymphedema Prevention in Breast Cancer: a Simple Blind, Randomized, Prospective Clinical Trial of the Efficacy of Physical Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: BREAST CANCER
LYMPHEDEMA
Keywords: Lymphedema
Prevention
Breast cancer
Physical therapy
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2008-09-26
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization and then post-operatively on hospital discharge (between Day 3 and Day 5), 4 weeks, and 3, 6, 12 and 24 months after surgery.
timeFrame: 2 years
Secondary outcomes:
measure: Pain, measured using the Visual Analogue Scale and Shoulder abduction measured using a digital goniometer.
timeFrame: 2 years
Other outcomes:
Locations:
city: Alcalá de Henares
country: Spain
facility: Alcalá University
state: Madrid
city: Alcalá de Henares
country: Spain
facility: María Torres Lacomba
state: Madrid
Study officials:
affiliation: Alcalá University
name: María Torres Lacomba, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Alcalá University
name: Maria José Yuste Sánchez, Prof.
role: STUDY_CHAIR
affiliation: Principe de Asturias Hospital University
name: Álvaro Zapico Goñi, MD
role: STUDY_CHAIR
affiliation: Department of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, UK
name: David Prieto Merino
role: STUDY_CHAIR
affiliation: Provincial Hospital.
name: Orlando Mayoral del Moral, Prof.
role: STUDY_CHAIR
References:
citation: Stout Gergich NL, Pfalzer LA, McGarvey C, Springer B, Gerber LH, Soballe P. Preoperative assessment enables the early diagnosis and successful treatment of lymphedema. Cancer. 2008 Jun 15;112(12):2809-19. doi: 10.1002/cncr.23494.