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

Primary Purpose

Arm Lymphedema After Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Multimodal treatment: compression bandaging and manual lymph drainage.
Manual lymph drainage
Sponsored by
University of Malaga
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arm Lymphedema After Breast Cancer focused on measuring compression bandage, manual lymphatic drainage, lymphedema, breast cancer, qualitative research.

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Málaga

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Manual lymphatic drainage and compression bandaging

Manual lymphatic drainage

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Perimetry
Arm volume is measured with perimetry through truncation of cones formula

Secondary Outcome Measures

Handgrip strength
Handgrip strength will be determined using hydraulic hand dynamometer "JAMAR"
Multiple sit-to-stant test
Multiple sit-to-stant test will be used to evaluate lower limbs strength.
Degree of pain
The degree of pain in the affected side with lymphedema will be measured by digital algometer "Commander ™"
Pulmonary function test
Simple spirometry to measure lung function with a spirometer "DATOSPIR120"
Maximal inspiratory pressures (MIP) and maximal expiratory pressures (MEP)
The strength of the respiratory muscles is measured through a digital manovacuometer (DATOSPIR120)
Six-minute walking test
Cardiorespiratory functional capacity as measured with six-minute walking test.
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
EORTIC-QLQ-C30 questionnaire
EORTIC-QLQ-C30 questionnaire measures the quality of life in cancer. Alpha of cronbach: 0,52 y 0,89
QLQ BR23 questionnaire
QLQ BR23 questionnaire to know quality of life in patients with breast cancer. Alpha of cronbach: 0,48 y 0,94
HADS questionnaire
HADS questionnaire to measure depression and anxiety. Alpha of cronbach: 0´8-0´76
QuickPIPPER questionnaire
QuickPIPPER questionnaire measures the level of fatigue in breast cancer. Alpha of cronbach: 0,730- 0,961
The short version of the IPAQ
The short version of the IPAQ questionnaire for physical activity level. Alpha of cronbach: 0,75
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.
Smartphone-based application
Smartphone-based application to analyze the treatment adherence of the participants

Full Information

First Posted
June 13, 2014
Last Updated
June 13, 2014
Sponsor
University of Malaga
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1. Study Identification

Unique Protocol Identification Number
NCT02165696
Brief Title
Compression Bandaging and Manual Lymph Drainage in Women With Lymphedema
Acronym
LYMPHATIC
Official Title
Effectiveness of the Combination of Compression Bandaging and Manual Lymph Drainage in Women With Secondary Lymphedema After Breast Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaga

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arm Lymphedema After Breast Cancer
Keywords
compression bandage, manual lymphatic drainage, lymphedema, breast cancer, qualitative research.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Manual lymphatic drainage and compression bandaging
Arm Type
Experimental
Arm Description
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
Arm Title
Manual lymphatic drainage
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Multimodal treatment: compression bandaging and manual lymph drainage.
Other Intervention Name(s)
Multimodal treatment
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Manual lymph drainage
Intervention Description
30 minutes and one hour maximum time of manual lymphatic drainage. The treatment will be carried out for six weeks five days a week.
Primary Outcome Measure Information:
Title
Perimetry
Description
Arm volume is measured with perimetry through truncation of cones formula
Time Frame
Baseline, 6 weeks and 12 weeks
Secondary Outcome Measure Information:
Title
Handgrip strength
Description
Handgrip strength will be determined using hydraulic hand dynamometer "JAMAR"
Time Frame
Baseline, 6 weeks and 12 weeks
Title
Multiple sit-to-stant test
Description
Multiple sit-to-stant test will be used to evaluate lower limbs strength.
Time Frame
Baseline, 6 weeks and 12 weeks
Title
Degree of pain
Description
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
Title
Pulmonary function test
Description
Simple spirometry to measure lung function with a spirometer "DATOSPIR120"
Time Frame
Baseline, 6 weeks and 12 weeks
Title
Maximal inspiratory pressures (MIP) and maximal expiratory pressures (MEP)
Description
The strength of the respiratory muscles is measured through a digital manovacuometer (DATOSPIR120)
Time Frame
Baseline, 6 weeks and 12 weeks
Title
Six-minute walking test
Description
Cardiorespiratory functional capacity as measured with six-minute walking test.
Time Frame
Baseline, 6 weeks and 12 weeks
Title
FACT-B+4 questionnaire
Description
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
Title
EORTIC-QLQ-C30 questionnaire
Description
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
Title
QLQ BR23 questionnaire
Description
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
Title
HADS questionnaire
Description
HADS questionnaire to measure depression and anxiety. Alpha of cronbach: 0´8-0´76
Time Frame
Baseline, 6 weeks and 12 weeks
Title
QuickPIPPER questionnaire
Description
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
Title
The short version of the IPAQ
Description
The short version of the IPAQ questionnaire for physical activity level. Alpha of cronbach: 0,75
Time Frame
Baseline, 6 weeks and 12 weeks
Title
Qualitative measures
Description
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
Title
Smartphone-based application
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martín-Valero R., Ph D
Phone
34 657834413
Email
rovalemas@gmail.com
Facility Information:
Facility Name
University of Málaga
City
Málaga
Country
Spain

12. IPD Sharing Statement

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Compression Bandaging and Manual Lymph Drainage in Women With Lymphedema

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