Know Cancer

or
forgot password

A Randomized, Controlled Clinical Trial About the Contribution of Manual Lymph Drainage in Complex Physical Therapy for Patients With Lymphoedema Secondary to Mastectomy


Phase 4
18 Years
N/A
Open (Enrolling)
Female
Lymphoedema

Thank you

Trial Information

A Randomized, Controlled Clinical Trial About the Contribution of Manual Lymph Drainage in Complex Physical Therapy for Patients With Lymphoedema Secondary to Mastectomy


Inclusion Criteria:



- women older than 18 years, intervented of unilateral breast neoplasia with
ipsilateral axillar lymphadenectomy

- Patients with ipsilateral lymphoedema with a volume difference of at least 200ml
compared to the lateral limb

- Patients who have finished the treatment with Radiotherapy and / or chemotherapy at
least six months before the study started

- Informed acceptance has to be signed

Exclusion Criteria:

- Bilateral affectation of both extremities.

- Malignant Active disease

- Acute Lymphoedema (in the first three months postintervention)

- Patients with previous paralysis or vascular alteration in the affected arm

- Patients with a major limitation of 30 ┬║ in any of the arches of movement of the
ipsilateral shoulder

- Patients with contraindication for Lymphatic Manual Drainage (cellulite, deep venous
thrombosis, heart failure, not controlled hypertension, renal failure and important
radiodermatitis)

- Patients who have been managed with treatment of rehabilitation in three months
previous to the recruitment.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Statistical analysis

Outcome Description:

All the patients included in the study will be analyzed and all the analyses will be performed for " intention of treating " except that related to the withdrawal of the treatment that will be done by protocol. Firstly an analysis of comparability of the groups using the test of the T de Student or Mann-Withney's Test and test of Fischer┬┤s exact test will be performed. Efficacy analysis:means differences and / or reason of medians for the quantitative variables and reason of risks and NNT for the quantitative variables.

Outcome Time Frame:

1 year after the clinical trial ends

Safety Issue:

Yes

Authority:

Spain: Ethics Committee

Study ID:

TFCDLM-07

NCT ID:

NCT01152099

Start Date:

September 2007

Completion Date:

April 2014

Related Keywords:

  • Lymphoedema
  • Postmastectomy
  • Lymphedema

Name

Location