Lymphoedema prevention in breast cancer
| ISRCTN | ISRCTN95870846 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95870846 |
| Secondary identifying numbers | ID1124 |
- 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
Scientific
Universidad de Alcala
Campus Externo
Escuela de Fisioterapia
Ctra. Madrid-Barcelona km. 33.600
Alcala de Henares, Madrid
28871
Spain
Study information
| Study design | Prospective randomised single-centre controlled single-blinded trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet (Spanish only) |
| 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 | 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 study start date | 15/05/2005 |
| Completion date | 15/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 120 women |
| 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
28871
Spain
Sponsor information
The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain)
Government
Government
C/ Sinesio Delgado no 6
Pabellon 6
Madrid
28029
Spain
| Website | http://www.isciii.es/htdocs/index.jsp |
|---|---|
"ROR" |
https://ror.org/00ca2c886 |
Funders
Funder type
Government
The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain) (ref: PI071124)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
