Welcome
Support Centre
25 October 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
Lymphoedema prevention in breast cancer
ISRCTN ISRCTN95870846
DOI 10.1186/ISRCTN95870846
ClinicalTrials.gov identifier
EudraCT number
Public title Lymphoedema prevention in breast cancer
Scientific title Lymphoedema prevention in breast cancer: a simple blind, randomised, prospective clinical trial of the efficacy of early physical therapy
Acronym N/A
Serial number at source ID1124
Study hypothesis Physical therapy could be an effective measure to prevent lymphoedema in patients undergoing breast cancer surgery including axillary lymph-node dissection.
Lay summary
Ethics approval Principe de Asturias Hospital's Human Research Ethics Committee approved the study in February 2005.
Study design Prospective, randomised, single-centre, controlled, single-blinded trial
Countries of recruitment Spain
Disease/condition/study domain Breast cancer
Participants - inclusion criteria 1. Consecutive women diagnosed with breast cancer and undergoing unilateral surgery with axillary lymph-node dissection at the Principe de Asturias Hospital in Alcala de Henares, Madrid (Spain)
2. Aged 18 to 70 years old
Participants - exclusion criteria 1. Without axillary lymph-node dissection or with bilateral breast cancer (BC)
2. Systemic disease
3. Locoregional recurrence
4. Any contraindication to physical therapy
Anticipated start date 15/05/2005
Anticipated end date 15/05/2009
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet (Spanish only)
Target number of participants 120 women
Interventions Intervention group:
Physical 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, lymphoedema source, the identification of possible precipitating factors, etc.

Control group:
Educational strategy including instruction with printed materials about the lymphatic system, concepts of normal load versus overload, lymphoedema source, the identification of possible precipitating factors, etc.

In order to use the same ES in both groups, a consensus was achieved before starting the study. In both groups patients were taken immediately after hospital discharge to either the EPT or to the CG programs. Both programs consisted of a three-week period with three visits per week. Each participant was assessed pre-operatively prior to randomisation and then post-operatively on hospital discharge (between day 3 and day 5), 4 weeks, and 3, 6 and 12 months after surgery.

This intervention study was conducted as a single-blinded randomised-controlled trial, as the physical therapist performing follow-up assessments remained blinded to the group allocation of the subjects.
Primary outcome measure(s) Circumference measurements of the upper limbs using a standard 1 cm wide, at 5 cm intervals from the elbow fold pre-operatively prior to randomisation and then post-operatively on hospital discharge (between day 3 and day 5), 4 weeks, and 3, 6, 12 and 24 months after surgery.
Secondary outcome measure(s) 1. Pain, measured using the Visual Analogue Scale (VAS) score (0 = no pain, 10 = unbearable pain) pre-operatively prior to randomisation 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. Range of shoulder abduction using a digital goniometer pre-operatively prior to randomisation and then post-operatively on hospital discharge (between day 3 and day 5), 4 weeks, and 3, 6, 12 and 24 months after surgery
Sources of funding The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain) (ref: PI071124)
Trial website
Publications 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20068255
Contact name Prof  Maria  Torres Lacomba
  Address Universidad de Alcala
Campus Externo
Escuela de Fisioterapia
Ctra. Madrid-Barcelona km. 33.600
  City/town Alcala de Henares, Madrid
  Zip/Postcode 28871
  Country Spain
Sponsor The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain)
  Address C/ Sinesio Delgado no 6
Pabellon 6
  City/town Madrid
  Zip/Postcode 28029
  Country Spain
  Sponsor website: http://www.isciii.es/htdocs/index.jsp
Date applied 24/09/2008
Last edited 15/01/2010
Date ISRCTN assigned 08/10/2008
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.