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Lymphoedema prevention in breast cancer

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN95870846
Enrollment
120
Registered
2008-10-08
Start date
2005-05-15
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer Cancer Malignant neoplasm of the breast

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 fu

Sponsors

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

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 1, 2026