Lymphoedema prevention in breast cancer

ISRCTN	ISRCTN95870846
DOI	https://doi.org/10.1186/ISRCTN95870846
Protocol serial number	ID1124
Sponsor	The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain)
Funder	The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain) (ref: PI071124)

Submission date: 24/09/2008
Registration date: 08/10/2008
Last edited: 15/09/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Maria Torres Lacomba
Scientific

Universidad de Alcala
Campus Externo
Escuela de Fisioterapia
Ctra. Madrid-Barcelona km. 33.600
Alcala de Henares, Madrid
28871
Spain

Study information

Primary study design	Interventional
Study design	Prospective randomised single-centre controlled single-blinded trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Lymphoedema prevention in breast cancer: a simple blind, randomised, prospective clinical trial of the efficacy of early physical therapy
Study objectives	Physical therapy could be an effective measure to prevent lymphoedema in patients undergoing breast cancer surgery including axillary lymph-node dissection.
Ethics approval(s)	Principe de Asturias Hospital's Human Research Ethics Committee approved the study in February 2005
Health condition(s) or problem(s) studied	Breast cancer
Intervention	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.
Intervention type	Other
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.
Key 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
Completion date	15/05/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	120
Key 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
Key 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
Date of first enrolment	15/05/2005
Date of final enrolment	15/05/2009

Locations

Countries of recruitment

Spain

Study participating centre

Universidad de Alcala

Alcala de Henares, Madrid
28871
Spain

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	12/01/2010		Yes	No
Results article	results	01/02/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes