Condition category
Cancer
Date applied
24/09/2008
Date assigned
08/10/2008
Last edited
15/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Maria Torres Lacomba

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ID1124

Study information

Scientific title

Lymphoedema prevention in breast cancer: a simple blind, randomised, prospective clinical trial of the efficacy of early physical therapy

Acronym

Study hypothesis

Physical therapy could be an effective measure to prevent lymphoedema in patients undergoing breast cancer surgery including axillary lymph-node dissection.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet (Spanish only)

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 measures

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

Overall trial start date

15/05/2005

Overall trial end date

15/05/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

120 women

Participant 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

Recruitment start date

15/05/2005

Recruitment end date

15/05/2009

Locations

Countries of recruitment

Spain

Trial participating centre

Universidad de Alcala
Alcala de Henares, Madrid
28871
Spain

Sponsor information

Organisation

The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain)

Sponsor details

C/ Sinesio Delgado no 6
Pabellon 6
Madrid
28029
Spain

Sponsor type

Government

Website

http://www.isciii.es/htdocs/index.jsp

Funders

Funder type

Government

Funder name

The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain) (ref: PI071124)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20068255
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25499599

Publication citations

  1. Results

    Torres Lacomba M, Yuste Sánchez MJ, Zapico Goñi A, Prieto Merino D, Mayoral del Moral O, Cerezo Téllez E, Minayo Mogollón E, Effectiveness of early physiotherapy to prevent lymphoedema after surgery for breast cancer: randomised, single blinded, clinical trial., BMJ, 2010, 340, b5396.

  2. Results

    Yuste Sánchez MJ, Lacomba MT, Sánchez BS, Merino DP, da Costa SP, Téllez EC, Zapico Goñi Á, Health related quality of life improvement in breast cancer patients: secondary outcome from a simple blinded, randomised clinical trial, Breast, 2015, 24, 1, 75-81, doi: 10.1016/j.breast.2014.11.012.

Additional files

Editorial Notes