An interventional study of Early Physical Therapy and Educational strategy in BREAST CANCER and LYMPHEDEMA, sponsored by University of Alcala. Completed at 2 sites in Spain. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-08-25.
Sponsored by University of Alcala · Not applicable, Interventional, and Prevention
OBJECTIVE: To find out the effectiveness of early application of physical therapy in the prevention of lymphedema after breast surgery and lymphadenectomy.
DESIGN: Randomized, controlled and single blinded clinical trial. Three years duration. Patients will be randomly assigned to one of these groups: Experimental group: Early physical therapy + training in means of prevention; Control group: just training in means of prevention. In both groups several physical therapy assessments will be undertaken: 1st before surgery; 2nd immediately after surgery; 3rd after completing intervention; 4th, 5th and 6th after 3, 6, 12 and 24 months.
SUBJECTS: Women with breast cancer treated with breast surgery including lymphadenectomy in Principe de Asturias Hospital, provided that there is no contraindication for physical therapy, and after reading, understanding and freely signing an informed consent form.
SAMPLE SIZE: A total of 116 subjects will be included in the study (58 subjects in each group), assuming a 15% of drop-outs and at least 20% reduction, with a statistical power of 60%.
DATA ANALYSIS: To find out the effectiveness of intervention we will compare the rate of lymphedema in both groups by means of a logistic regression analysis, in which the main factor is the intervention group. Other factors aimed to control the effect of the intervention will also be included. In order to compare the rate of appearance of lymphedema in both groups, a survival analysis will also be included.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 120 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Alcala is the lead sponsor of 123 studies on the registry; 36 are open to participants now.
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Exclusion Criteria:
Early Physical Therapy 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, lymphedema source, the identification of possible precipitating factors, etc.
Other: Early Physical Therapy and Educational strategy
Educational Strategy: instruction with printed materials about the lymphatic system, concepts of normal load versus overload, lymphedema source, the identification of possible precipitating factors, etc.
Other: Early Physical Therapy and Educational strategy
Experimental group: physical therapy 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, lymphedema source, the identification of possible precipitating factors,etc. Other: control group: only the educational strategy
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.
Time frame: 2 years
Pain, measured using the Visual Analogue Scale and Shoulder abduction measured using a digital goniometer.
Time frame: 2 years
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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University of Alcala