Clinical trial NCT02165696: Compression Bandaging and Manual Lymph Drainage in Women With Lymphedema
Official title: Effectiveness of the Combination of Compression Bandaging and Manual Lymph Drainage in Women With Secondary Lymphedema After Breast Cancer.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arm Lymphedema After Breast Cancer
Keywords: compression bandage, manual lymphatic drainage, lymphedema, breast cancer, qualitative research.
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2014-06-17
Enrollment: 44
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lymphedema is the result of accumulation of fluid and other elements in tissue spaces because of an imbalance between the production of fluid interstitial and transport. Lymphedema can cause significant physical and psychological morbidity. Prevalence of lymphedema in patients after breast cancer surgery is 12-60% and the incidence is 12-26%.Psychological and social consequences of secondary lymphedema related breast cancer have been little recognized and documented. Although, it have performed many studies related secondary lymphedema it not found sufficient evidence in the literature to suggest the most effective treatment. There is some evidence suggesting that compression therapy and manual lymphatic drainage can improve lymphedema but more studies are needed. The aim of this research is to to evaluate the clinical effect of multimodal treatment (compression bandaging and manual lymph drainage) versus applying manual lymphatic drainage in women with arm lymphedema after breast cancer surgery.

Detailed description: This study has two sub research: a quantitative approach and a qualitative approach. The research will be carried out by a multicenter way

Quantitative approach consist in carried out a single-blind randomized controlled trial of 44 women with arm lymphedema. Patients will be distributed in two intervention groups by a randomized way. Participants will be given his assignment by closed envelope. Both treatments will be administered five days a week for six weeks. The experimental group (n=22) will receive multimodal treatment: combination of manual lymphatic drainage and compression bandaging. The control group (n=22) only will receive manual lymphatic drainage. We want to determinate the effect on volume arm decrease, quality of life, level of hand strength, degree of pain, fatigue level, and state of anxiety and depression. The influence on the lymphedema will be analyzed with lower limbs strength, physical activity, lung function, respiratory muscle strength by maximal inspiratory and expiratory pressure measurements (MIP and MEP) and cardiorespiratory functional capacity. Patients adherence will be analyzed by a smartphone.

Qualitative apprach: to know the perceptions and experiences of the participants in both interventions groups through a qualitative descriptive study. Data will be obtained with semi-structured depth interview.

Eligibility criteria: Inclusion Criteria:

* Women between 45 and 65 years with secondary lymphedema in upper limb after breast cancer surgery.
* Cancer stages I-III according to TNM classification of the American Joint Committee on Cancer.

Exclusion Criteria:

* To have received lymphedema treatment previously.
* To be treated by radiation therapy or chemotherapy.
* Distant metastases or local recurrence of cancer.
* Infectious signs in the upper limb with lymphedema.
* Uncontrolled hypertension.
* Heart disease.

Primary outcomes:
measure: Perimetry
timeFrame: Baseline, 6 weeks and 12 weeks
Secondary outcomes:
measure: Handgrip strength
timeFrame: Baseline, 6 weeks and 12 weeks
measure: Multiple sit-to-stant test
timeFrame: Baseline, 6 weeks and 12 weeks
measure: Degree of pain
timeFrame: Baseline, 6 weeks and 12 weeks
measure: Pulmonary function test
timeFrame: Baseline, 6 weeks and 12 weeks
measure: Maximal inspiratory pressures (MIP) and maximal expiratory pressures (MEP)
timeFrame: Baseline, 6 weeks and 12 weeks
measure: Six-minute walking test
timeFrame: Baseline, 6 weeks and 12 weeks
measure: FACT-B+4 questionnaire
timeFrame: Baseline, 6 weeks and 12 weeks
measure: EORTIC-QLQ-C30 questionnaire
timeFrame: Baseline, 6 weeks and 12 weeks
measure: QLQ BR23 questionnaire
timeFrame: Baseline, 6 weeks and 12 weeks
measure: HADS questionnaire
timeFrame: Baseline, 6 weeks and 12 weeks
measure: QuickPIPPER questionnaire
timeFrame: Baseline, 6 weeks and 12 weeks
measure: The short version of the IPAQ
timeFrame: Baseline, 6 weeks and 12 weeks
measure: Qualitative measures
timeFrame: 6 weeks
measure: Smartphone-based application
timeFrame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: University of Málaga
Study officials:
References: