Lymphedema Prevention in Breast Cancer

NCT00760123 | Completed DMC

• 1 other identifier: ID1124
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

BREAST CANCER; LYMPHEDEMA

Keywords

Lymphedema; Prevention; Breast cancer; Physical therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (1)

• Pain, measured using the Visual Analogue Scale and Shoulder abduction measured using a digital goniometer.

  2 years

Study Arms (2)

1

EXPERIMENTAL

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.

Other: Early Physical Therapy and Educational strategy

2

OTHER

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.

Other: Early Physical Therapy and Educational strategy

Interventions

Early Physical Therapy and Educational strategy OTHER

Experimental group: 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. Other: control group: only the educational strategy

1; 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (2)

Alcalá University

Alcalá de Henares, Madrid, 28871, Spain

Location

María Torres Lacomba

Alcalá de Henares, Madrid, 28871, Spain

Location

Related Publications (1)

• 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.

  PMID: 18428212 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Lymphedema

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• María Torres Lacomba, Prof.

  Alcalá University

  PRINCIPAL INVESTIGATOR

• Maria José Yuste Sánchez, Prof.

  Alcalá University

  STUDY CHAIR

• Álvaro Zapico Goñi, MD

  Principe de Asturias Hospital University

  STUDY CHAIR

• David Prieto Merino

  Department of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, UK

  STUDY CHAIR

• Orlando Mayoral del Moral, Prof.

  Provincial Hospital.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Professor

Study Record Dates

• First Submitted: September 25, 2008
• First Posted: September 26, 2008
• Study Start: May 1, 2005
• Primary Completion: June 1, 2009
• Study Completion: December 1, 2009
• Last Updated: August 25, 2014

Record last verified: 2014-08

Locations

ES (2)