Compression Bandaging and Manual Lymph Drainage in Women With Lymphedema (LYMPHATIC)

Effectiveness of the Combination of Compression Bandaging and Manual Lymph Drainage in Women With Secondary Lymphedema After Breast Cancer.

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.

Study Overview

• Status: Unknown
• Conditions: Arm Lymphedema After Breast Cancer
• Intervention / Treatment: Other: Multimodal treatment: compression bandaging and manual lymph drainage.; Other: Manual lymph drainage

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.

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martín-Valero R., Ph D; Phone Number: 34 657834413; Email: rovalemas@gmail.com

Study Locations

• Spain
  • Málaga, Spain
    • University of Malaga

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Manual lymphatic drainage and compression bandaging; 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.; 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 Names: Multimodal treatment
ACTIVE_COMPARATOR: Manual lymphatic 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. The treatment will be carried out for six weeks five days a week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perimetry	Arm volume is measured with perimetry through truncation of cones formula	Baseline, 6 weeks and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Handgrip strength	Handgrip strength will be determined using hydraulic hand dynamometer "JAMAR"	Baseline, 6 weeks and 12 weeks
Multiple sit-to-stant test	Multiple sit-to-stant test will be used to evaluate lower limbs strength.	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 ™"	Baseline, 6 weeks and 12 weeks
Pulmonary function test	Simple spirometry to measure lung function with a spirometer "DATOSPIR120"	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)	Baseline, 6 weeks and 12 weeks
Six-minute walking test	Cardiorespiratory functional capacity as measured with six-minute walking test.	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	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	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	Baseline, 6 weeks and 12 weeks
HADS questionnaire	HADS questionnaire to measure depression and anxiety. Alpha of cronbach: 0´8-0´76	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	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	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.	6 weeks
Smartphone-based application	Smartphone-based application to analyze the treatment adherence of the participants	Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks

Collaborators and Investigators

• Sponsor: University of Malaga

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (ANTICIPATED): December 1, 2015
• Study Completion (ANTICIPATED): December 1, 2015

Study Registration Dates

• First Submitted: June 13, 2014
• First Submitted That Met QC Criteria: June 13, 2014
• First Posted (ESTIMATE): June 17, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): June 17, 2014
• Last Update Submitted That Met QC Criteria: June 13, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: compression bandage, manual lymphatic drainage, lymphedema, breast cancer, qualitative research.
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Lymphedema
• Other Study ID Numbers: UMA_CBM_2014/LYMP; Lymphatic Multimodal Treatment