Arm Lymphedema After Breast CancerLYMPHATICNCT02165696
Compression Bandaging and Manual Lymph Drainage in Women With Lymphedema
A study testing Multimodal treatment: compression bandaging and manual lymph drainage. and Manual lymph drainage in people with Arm Lymphedema After Breast Cancer, run by University of Malaga at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Arm Lymphedema After Breast Cancer
- What is being tested?
- Multimodal treatment: compression bandaging and manual lymph drainage. and Manual lymph drainage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Arm Lymphedema After Breast Cancer
- Being tested
- Multimodal treatment: compression bandaging and manual lymph drainage., Manual lymph drainage
- Keywords
- compression bandage, manual lymphatic drainage, lymphedema, breast cancer, qualitative research.
- Medical subject headings
- Lymphedema, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal treatment: compression bandaging and manual lymph drainage.Other
Also called Multimodal treatment
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
Manual lymph drainageOther
30 minutes and one hour maximum time of manual lymphatic drainage. The treatment will be carried out for six weeks five days a week.
| Study group | Role | What they receive |
|---|---|---|
| Manual lymphatic drainage and compression bandaging | Experimental | 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 Receives: Other: Multimodal treatment: compression bandaging and manual lymph drainage. |
| Manual lymphatic drainage | Active comparator | 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. Receives: Other: Manual lymph drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perimetry
Arm volume is measured with perimetry through truncation of cones formula
Measured: Baseline, 6 weeks and 12 weeks
Secondary outcomes (14)
Handgrip strength
Handgrip strength will be determined using hydraulic hand dynamometer "JAMAR"
Measured: Baseline, 6 weeks and 12 weeks
Multiple sit-to-stant test
Multiple sit-to-stant test will be used to evaluate lower limbs strength.
Measured: 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 ™"
Measured: Baseline, 6 weeks and 12 weeks
Pulmonary function test
Simple spirometry to measure lung function with a spirometer "DATOSPIR120"
Measured: 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)
Measured: Baseline, 6 weeks and 12 weeks
Six-minute walking test
Cardiorespiratory functional capacity as measured with six-minute walking test.
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, 6 weeks and 12 weeks
HADS questionnaire
HADS questionnaire to measure depression and anxiety. Alpha of cronbach: 0´8-0´76
Measured: 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
Measured: 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
Measured: 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.
Measured: 6 weeks
Smartphone-based application
Smartphone-based application to analyze the treatment adherence of the participants
Measured: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arm Lymphedema After Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rocío Martín Valero, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02165696
- Sponsor's protocol ID
- UMA_CBM_2014/LYMP
- Other IDs
- Lymphatic Multimodal Treatment
- Acronym
- LYMPHATIC
- Status last verified
- Jun 2014
- First submitted
- 13 Jun 2014
- Last updated
- 17 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Combination of Compression Bandaging and Manual Lymph Drainage in Women With Secondary Lymphedema After Breast Cancer.
- ClinicalTrials.gov ID
- NCT02165696
- Acronym / sponsor ID
- LYMPHATIC / UMA_CBM_2014/LYMP
- Conditions
- Arm Lymphedema After Breast Cancer
- Keywords
- compression bandage, manual lymphatic drainage, lymphedema, breast cancer, qualitative research.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 17 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual lymphatic drainage and compression bandaging | Experimental | Other: Multimodal treatment: compression bandaging and manual lymph drainage.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 |
| Manual lymphatic drainage | Active comparator | Other: Manual lymph drainageControl 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. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal treatment: compression bandaging and manual lymph drainage.Also: Multimodal treatment30 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 | Manual lymphatic drainage and compression bandaging |
| Manual lymph drainage30 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 lymphatic drainage |
Primary outcome
Perimetry
Time frame: Baseline, 6 weeks and 12 weeks
Arm volume is measured with perimetry through truncation of cones formula
14 secondary outcomes
Handgrip strength
Time frame: Baseline, 6 weeks and 12 weeks
Multiple sit-to-stant test
Time frame: Baseline, 6 weeks and 12 weeks
Degree of pain
Time frame: Baseline, 6 weeks and 12 weeks
Pulmonary function test
Time frame: Baseline, 6 weeks and 12 weeks
Maximal inspiratory pressures (MIP) and maximal expiratory pressures (MEP)
Time frame: Baseline, 6 weeks and 12 weeks
Six-minute walking test
Time frame: Baseline, 6 weeks and 12 weeks
FACT-B+4 questionnaire
Time frame: Baseline, 6 weeks and 12 weeks
EORTIC-QLQ-C30 questionnaire
Time frame: Baseline, 6 weeks and 12 weeks
QLQ BR23 questionnaire
Time frame: Baseline, 6 weeks and 12 weeks
HADS questionnaire
Time frame: Baseline, 6 weeks and 12 weeks
QuickPIPPER questionnaire
Time frame: Baseline, 6 weeks and 12 weeks
The short version of the IPAQ
Time frame: Baseline, 6 weeks and 12 weeks
Qualitative measures
Time frame: 6 weeks
Smartphone-based application
Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal treatment: compression bandaging and manual lymph drainage. and Manual lymph drainage in people with Arm Lymphedema After Breast Cancer, run by University of Malaga at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martín-Valero R., Ph D (34 657834413, rovalemas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perimetry (time frame: Baseline, 6 weeks and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2014.