An interventional study of Multimodal treatment: compression bandaging and manual lymph drainage. and Manual lymph drainage in Arm Lymphedema After Breast Cancer, sponsored by University of Malaga. Status unknown at 1 site in Spain. Open to female participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-06-17.
Sponsored by University of Malaga · Not applicable, Interventional, and Treatment
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 44 is below the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
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Exclusion Criteria:
Experimental group: 30 minutes and one hour maximum time of manual lymphatic drainage and compression bandaging with multilayer inelastic bandages with low extensibility. It is possible to apply bandages two or three times per week. Also, an elastic bandage is also held in hand fingers with slight compression and other protective bandage is used in skin. The treatment will be carried out for six weeks five days a week
Other: Multimodal treatment: compression bandaging and manual lymph drainage.
Control group: 30 minutes and one hour maximum time of manual lymphatic drainage. The treatment will be carried out for six weeks five days a week.
Other: Manual lymph drainage
30 minutes and one hour maximum time of manual lymphatic drainage and compression bandaging with multilayer inelastic bandages with low extensibility. It is possible to apply bandages two or three times per week. Also, an elastic bandage is also held in hand fingers with slight compression and other protective bandage is used in skin. The treatment will be carried out for six weeks five days a week
Also known as: Multimodal treatment
30 minutes and one hour maximum time of manual lymphatic drainage. The treatment will be carried out for six weeks five days a week.
Perimetry
Arm volume is measured with perimetry through truncation of cones formula
Time frame: Baseline, 6 weeks and 12 weeks
Handgrip strength
Handgrip strength will be determined using hydraulic hand dynamometer "JAMAR"
Time frame: Baseline, 6 weeks and 12 weeks
Multiple sit-to-stant test
Multiple sit-to-stant test will be used to evaluate lower limbs strength.
Time frame: Baseline, 6 weeks and 12 weeks
Degree of pain
The degree of pain in the affected side with lymphedema will be measured by digital algometer "Commander ™"
Time frame: Baseline, 6 weeks and 12 weeks
Pulmonary function test
Simple spirometry to measure lung function with a spirometer "DATOSPIR120"
Time frame: Baseline, 6 weeks and 12 weeks
Maximal inspiratory pressures (MIP) and maximal expiratory pressures (MEP)
The strength of the respiratory muscles is measured through a digital manovacuometer (DATOSPIR120)
Time frame: Baseline, 6 weeks and 12 weeks
Six-minute walking test
Cardiorespiratory functional capacity as measured with six-minute walking test.
Time frame: Baseline, 6 weeks and 12 weeks
FACT-B+4 questionnaire
FACT-B+4 questionnaire to measure quality of life in patients with breast cancer and lymphedema. Alpha of cronbach: 0,52-0,92
Time frame: Baseline, 6 weeks and 12 weeks
EORTIC-QLQ-C30 questionnaire
EORTIC-QLQ-C30 questionnaire measures the quality of life in cancer. Alpha of cronbach: 0,52 y 0,89
Time frame: Baseline, 6 weeks and 12 weeks
QLQ BR23 questionnaire
QLQ BR23 questionnaire to know quality of life in patients with breast cancer. Alpha of cronbach: 0,48 y 0,94
Time frame: Baseline, 6 weeks and 12 weeks
HADS questionnaire
HADS questionnaire to measure depression and anxiety. Alpha of cronbach: 0´8-0´76
Time frame: Baseline, 6 weeks and 12 weeks
QuickPIPPER questionnaire
QuickPIPPER questionnaire measures the level of fatigue in breast cancer. Alpha of cronbach: 0,730- 0,961
Time frame: Baseline, 6 weeks and 12 weeks
The short version of the IPAQ
The short version of the IPAQ questionnaire for physical activity level. Alpha of cronbach: 0,75
Time frame: Baseline, 6 weeks and 12 weeks
Qualitative measures
Data collection was carried out through an interview in-depth semi-structured. The dimensions of the study were developed based on bibliography and objectives of the study: perceptions and experiences with multimodal treatment, ways of living with lymphedema, life style, Physical activity and exercise.
Time frame: 6 weeks
Smartphone-based application
Smartphone-based application to analyze the treatment adherence of the participants
Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks
This study is status unknown, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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University of Malaga