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Lymphedema Prevention in Breast Cancer: a Simple Blind, Randomized, Prospective Clinical Trial of the Efficacy of Physical Therapy


N/A
18 Years
70 Years
Open (Enrolling)
Female
Breast Cancer, Lymphedema

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Trial Information

Lymphedema Prevention in Breast Cancer: a Simple Blind, Randomized, Prospective Clinical Trial of the Efficacy of Physical Therapy


Inclusion Criteria:



- Consecutive women diagnosed with breast cancer and undergoing unilateral surgery with
axillary lymph-node dissection at the Príncipe de Asturias Hospital in Alcalá de
Henares, Madrid (Spain) are candidates for inclusion in the study.

Exclusion Criteria:

- Patients without axillary lymph-node dissection or with bilateral BC, systemic
disease, locoregional recurrence, or any contraindication to physical therapy are
excluded from the study.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization and then post-operatively on hospital discharge (between Day 3 and Day 5), 4 weeks, and 3, 6, 12 and 24 months after surgery.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

María Torres Lacomba, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Alcalá University

Authority:

Spain: Ministry of Health

Study ID:

ID1124

NCT ID:

NCT00760123

Start Date:

May 2005

Completion Date:

December 2009

Related Keywords:

  • Breast Cancer
  • Lymphedema
  • Lymphedema
  • Prevention
  • Breast cancer
  • Physical therapy
  • Breast Neoplasms
  • Lymphedema

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