LymphoedemaNCT01152099
A Clinical Trial About the Contribution of Manual Lymph Drainage in Complex Physical Therapy for Patients With Lymphoedema Secondary to Mastectomy
A study testing Compression Bandaging and Manual Lymph Drainage (MLD) and Compression Bandaging in people with Lymphoedema, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 1 site in Spain.
Trial summary
Hypothesis: To know the utility of manual lymph drainage (MLD) as part of the Physical Complex Therapy has turn out relevant because of the exclusive dedication that it supposes to the therapist. To date, the evidence-base for MLD is very limited and only two studies analyze its relevance. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lymphoedema
- What is being tested?
- Compression Bandaging and Manual Lymph Drainage (MLD) and Compression Bandaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteSpain
- Study dates
- 11 Sep 2007to 24 Apr 2017
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women older than 18 years, intervented of unilateral breast neoplasia with ipsilateral axillar lymphadenectomy
- Patients with ipsilateral lymphoedema with a volume difference of at least 200ml compared to the lateral limb
- Patients who have finished the treatment with Radiotherapy and / or chemotherapy at least six months before the study started
- Informed acceptance has to be signed
Who cannot join
- Bilateral affectation of both extremities.
- Malignant Active disease
- Acute Lymphoedema (in the first three months postintervention)
- Patients with previous paralysis or vascular alteration in the affected arm
- Patients with a major limitation of 30 º in any of the arches of movement of the ipsilateral shoulder
- Patients with contraindication for Lymphatic Manual Drainage (cellulite, deep venous thrombosis, heart failure, not controlled hypertension, renal failure and important radiodermatitis)
- Patients who have been managed with treatment of rehabilitation in three months previous to the recruitment.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Rehabilitation Service. Hospital Universitario de La Princesa
Madrid, 28006
About this study
Official title: A Randomized, Controlled Clinical Trial About the Contribution of Manual Lymph Drainage in Complex Physical Therapy for Patients With Lymphoedema Secondary to Mastectomy
Hypothesis:
To know the utility of manual lymph drainage (MLD) as part of the Physical Complex Therapy has turn out relevant because of the exclusive dedication that it supposes to the therapist. To date, the evidence-base for MLD is very limited and only two studies analyze its relevance. The first study measured the effect of compression bandage with or without MLD. The group receiving compression and MLD had a significant reduction in limb volume and decreased pain, despite the fact the MLD was given only for one week (Johansson et al., 1999). A further study investigated the effect of eight sessions of MLD over two weeks in 42 women with breast cancer-related lymphoedema, and the findings suggested that MLD do not contribute significantly to oedema reduction, although the MLD course was relatively short and the study group was limited to those with mild to moderate swelling (20-30 % of difference). Information about the quality of life, using the questionnaire EORT QLQ-C30 was gathered but the results were not considered in the final assessment (Andersen and Cabbage 2000).
Read more
Similar studies would provide comparative and enlightening information with regard to the previous results. The investigators could determine if the MLD, in spite of not obtaining an improvement in the volume of the lymphoedema, provides a benefit in the reduction of the symptoms related to it.
The investigators hypothesized that MLD does not contribute significantly in volume limb reduction but it provides a clinical improvement regarding the quality of life according to the questionnaire EORT QLQ-C30.
For the calculation of the sample size the investigators depart from the following assumptions:
The effect of the standard treatment on the control group control will produce an average volume limb reduction of 5 %.
The effect of the treatment in the experimental group will be an average of the 25 % (a minor difference of effects would indicate a discreet effect of the tested treatment). The investigators also assume that, the standard deviation will be similar in both groups and near to 25 %. With this information and for an alpha risk of 0.05 and a power of 0.80 the calculation of the sample size is 20 patients in every group. Considering a rate of withdrawal of 30 % in every group, the appropriate sample size is 58 patients assigned in two groups of 29 patients.
Main aim:
To analyze the effectiveness of Manual Lymph Drainage (MLD) in the treatment of postmastectomy lymphoedema in order to reduce the volume of lymphoedema
Secondary aims:
To analyze the duration of the reduction of the lymphoedema in the time. To analyze the improvement in the concomitant symptomatology of the lymphoedema using the results of two quality of life tests validated in Spanish: EORTC QLQ-C30 version 2.0, for the cancer in general and EORTC QLQ-BR23 specifically for the breast cancer. In particular, the items refering to the upper extremity (47, 48, 49) and to the corporal image (39, 40, 41, 42) and in which the higher the score the worse the result.
Methodology:
Researching Project with methodology of randomized, controlled clinical trial. Group A or Control: patients with standard treatment (care the skin, exercise and measures of compression -bandage for one month and later a sleeve of compression).
Group B or Experimental: patients with standard treatment (care of the skin, exercise and measures of compression (bandage for one month and later a sleeve for lymphoedema) and in addition they receive Manual Lymph Drainage Main variable: Volume reduction of the affected arm after the treatment expressed in percentage.
Number of patients: 58 women.
- Conditions
- Lymphoedema
- Being tested
- Compression Bandaging, Manual Lymph Drainage (MLD) and Compression Bandaging
- Keywords
- Postmastectomy
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression BandagingOther
Group A or Control Group: ambulatory treatment is performed during one month. Specific exercises and prevention measures are taught. The tailor-made sleeve for lymphedema with gauntlet without protection at the edges and with extension to the shoulder is placed from the first four weeks of treatment. The sleeve is used during the whole day and a night interruption is allowed. Later the patient will continue domiciliary treatment realizing specific exercises for 30 minutes twice a day without fatigue carrying the lymphedema sleeve for at least 12 hours.
If after three months of treatment a good response is not obtained an ambulatory treatment will be introduced again for one month,and this time the treatment corresponding to the group B or experimental will be applied.
Manual Lymph Drainage (MLD) and Compression BandagingOther
Specific exercises measures of prevention are taught. MLD is carried out followed by a daily multilayer bandage during the first four weeks. The tailor-made sleeve for lymphedema with gauntlet without protection at the edges and with extension to the shoulder is placed from the first four weeks of treatment. The sleeve is used during the whole day and a night interruption is allowed. Later the patient will continue domiciliary treatment realizing specific exercises for 30 minutes twice a day without fatigue carrying the lymphedema sleeve for at least 12 hours.
If after three months of treatment a good response is not obtained an ambulatory treatment will be introduced again for one month, and this time the treatment corresponding to the group A or Control will be applied.
| Study group | Role | What they receive |
|---|---|---|
| GroupA | Active comparator | Ambulatory treatment is performed during one month. Specific exercises and prevention measures are taught. Multilayer bandage is applied daily during the first four weeks.
The tailor-made sleeve for lymphedema with gauntlet without protection at the edges and with extension to the shoulder is placed from the first four weeks of treatment. The sleeve is used during the whole day and a night interruption is allowed. Later the patient will continue domiciliary treatment realizing specific exercises for 30 minutes twice a day without fatigue carrying the lymphedema sleeve for at least 12 hours.
If after three months of treatment a good response is not obtained an ambulatory treatment will be introduced again for one month,and this time the treatment corresponding to the group B or experimental will be applied. Receives: Other: Compression Bandaging |
| GroupB | Experimental | Ambulatory treatment is carried out during one month. Specific exercises measures of prevention are taught. MLD is carried out followed by a daily multilayer bandage during the first four weeks. The tailor-made sleeve for lymphedema with gauntlet without protection at the edges and with extension to the shoulder is placed from the first four weeks of treatment. The sleeve is used during the whole day and a night interruption is allowed. Later the patient will continue domiciliary treatment realizing specific exercises for 30 minutes twice a day without fatigue carrying the lymphedema sleeve for at least 12 hours.
If after three months of treatment a good response is not obtained an ambulatory treatment will be introduced again for one month, and this time the treatment corresponding to the group A or Control will be applied. Receives: Other: Manual Lymph Drainage (MLD) and Compression Bandaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Statistical analysis
All the patients included in the study will be analyzed and all the analyses will be performed for " intention of treating " except that related to the withdrawal of the treatment that will be done by protocol.
Firstly an analysis of comparability of the groups using the test of the T de Student or Mann-Withney's Test and test of Fischer´s exact test will be performed. Efficacy analysis:means differences and / or reason of medians for the quantitative variables and reason of risks and NNT for the quantitative variables.
Measured: 1 year after the clinical trial ends
Secondary outcomes (1)
Statistical analysis
Analyses of Safety:side effects and / or withdrawal and / or complications rates.
In all cases analyses of the confidence intervals will be also calculated.
Analysis of the Quality of Life
Measured: 1 year after the clinical trial ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study start11 Sep 2007
- Primary completion24 Apr 2017
- Study completion24 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for LymphoedemaStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01152099
- Sponsor's protocol ID
- TFCDLM-07
- Status last verified
- Feb 2018
- First submitted
- 24 Jun 2010
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Kopanski Z, Wojewoda T, Wojewoda A, Schlegel-Zawadzka M, Wozniacka R, Suder A, Kosciuk T. Influence of some anthropometric parameters on the risk of development of distal complications after mastectomy carried out because of breast carcinoma. Am J Hum Biol. 2003 May-Jun;15(3):433-9. doi: 10.1002/ajhb.10158.
PubMed 12704719Johansson K, Lie E, Ekdahl C, Lindfeldt J. A randomized study comparing manual lymph drainage with sequential pneumatic compression for treatment of postoperative arm lymphedema. Lymphology. 1998 Jun;31(2):56-64.
PubMed 9664269Badger CM, Peacock JL, Mortimer PS. A randomized, controlled, parallel-group clinical trial comparing multilayer bandaging followed by hosiery versus hosiery alone in the treatment of patients with lymphedema of the limb. Cancer. 2000 Jun 15;88(12):2832-7.
PubMed 10870068Andersen L, Hojris I, Erlandsen M, Andersen J. Treatment of breast-cancer-related lymphedema with or without manual lymphatic drainage--a randomized study. Acta Oncol. 2000;39(3):399-405. doi: 10.1080/028418600750013186.
PubMed 10987238Harris SR, Hugi MR, Olivotto IA, Levine M; Steering Committee for Clinical Practice Guidelines for the Care and Treatment of Breast Cancer. Clinical practice guidelines for the care and treatment of breast cancer: 11. Lymphedema. CMAJ. 2001 Jan 23;164(2):191-9.
PubMed 11332311Foldi E, Foldi M, Clodius L. The lymphedema chaos: a lancet. Ann Plast Surg. 1989 Jun;22(6):505-15. doi: 10.1097/00000637-198906000-00007.
PubMed 2751222Ramos SM, O'Donnell LS, Knight G. Edema volume, not timing, is the key to success in lymphedema treatment. Am J Surg. 1999 Oct;178(4):311-5. doi: 10.1016/s0002-9610(99)00185-3.
PubMed 10587190McNeely ML, Magee DJ, Lees AW, Bagnall KM, Haykowsky M, Hanson J. The addition of manual lymph drainage to compression therapy for breast cancer related lymphedema: a randomized controlled trial. Breast Cancer Res Treat. 2004 Jul;86(2):95-106. doi: 10.1023/B:BREA.0000032978.67677.9f.
PubMed 15319562Badger C, Preston N, Seers K, Mortimer P. Physical therapies for reducing and controlling lymphoedema of the limbs. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD003141. doi: 10.1002/14651858.CD003141.pub2.
PubMed 15495042Martin ML, Hernandez MA, Avendano C, Rodriguez F, Martinez H. Manual lymphatic drainage therapy in patients with breast cancer related lymphoedema. BMC Cancer. 2011 Mar 9;11:94. doi: 10.1186/1471-2407-11-94.
PubMed 21392372
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Clinical Trial About the Contribution of Manual Lymph Drainage in Complex Physical Therapy for Patients With Lymphoedema Secondary to Mastectomy
- ClinicalTrials.gov ID
- NCT01152099
- Acronym / sponsor ID
- TFCDLM-07
- Conditions
- Lymphoedema
- Keywords
- Postmastectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaUniversity, hospital or other
- Study start
- 11 Sep 2007 (actual)
- Primary completion
- 24 Apr 2017 (actual)
- Study completion
- 24 Apr 2017 (actual)
- First posted
- 29 Jun 2010 (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.
Hypothesis:
To know the utility of manual lymph drainage (MLD) as part of the Physical Complex Therapy has turn out relevant because of the exclusive dedication that it supposes to the therapist. To date, the evidence-base for MLD is very limited and only two studies analyze its relevance. The first study measured the effect of compression bandage with or without MLD. The group receiving compression and MLD had a significant reduction in limb volume and decreased pain, despite the fact the MLD was given only for one week (Johansson et al., 1999). A further study investigated the effect of eight sessions of MLD over two weeks in 42 women with breast cancer-related lymphoedema, and the findings suggested that MLD do not contribute significantly to oedema reduction, although the MLD course was relatively short and the study group was limited to those with mild to moderate swelling (20-30 % of difference). Information about the quality of life, using the questionnaire EORT QLQ-C30 was gathered but the results were not considered in the final assessment (Andersen and Cabbage 2000).
Similar studies would provide comparative and enlightening information with regard to the previous results. The investigators could determine if the MLD, in spite of not obtaining an improvement in the volume of the lymphoedema, provides a benefit in the reduction of the symptoms related to it.
The investigators hypothesized that MLD does not contribute significantly in volume limb reduction but it provides a clinical improvement regarding the quality of life according to the questionnaire EORT QLQ-C30.
For the calculation of the sample size the investigators depart from the following assumptions:
The effect of the standard treatment on the control group control will produce an average volume limb reduction of 5 %.
The effect of the treatment in the experimental group will be an average of the 25 % (a minor difference of effects would indicate a discreet effect of the tested treatment). The investigators also assume that, the standard deviation will be similar in both groups and near to 25 %. With this information and for an alpha risk of 0.05 and a power of 0.80 the calculation of the sample size is 20 patients in every group. Considering a rate of withdrawal of 30 % in every group, the appropriate sample size is 58 patients assigned in two groups of 29 patients.
Main aim:
To analyze the effectiveness of Manual Lymph Drainage (MLD) in the treatment of postmastectomy lymphoedema in order to reduce the volume of lymphoedema
Secondary aims:
To analyze the duration of the reduction of the lymphoedema in the time. To analyze the improvement in the concomitant symptomatology of the lymphoedema using the results of two quality of life tests validated in Spanish: EORTC QLQ-C30 version 2.0, for the cancer in general and EORTC QLQ-BR23 specifically for the breast cancer. In particular, the items refering to the upper extremity (47, 48, 49) and to the corporal image (39, 40, 41, 42) and in which the higher the score the worse the result.
Methodology:
Researching Project with methodology of randomized, controlled clinical trial. Group A or Control: patients with standard treatment (care the skin, exercise and measures of compression -bandage for one month and later a sleeve of compression).
Group B or Experimental: patients with standard treatment (care of the skin, exercise and measures of compression (bandage for one month and later a sleeve for lymphoedema) and in addition they receive Manual Lymph Drainage Main variable: Volume reduction of the affected arm after the treatment expressed in percentage.
Number of patients: 58 women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GroupA | Active comparator | Other: Compression BandagingAmbulatory treatment is performed during one month. Specific exercises and prevention measures are taught. Multilayer bandage is applied daily during the first four weeks. The tailor-made sleeve for lymphedema with gauntlet without protection at the edges and with extension to the shoulder is placed from the first four weeks of treatment. The sleeve is used during the whole day and a night interruption is allowed. Later the patient will continue domiciliary treatment realizing specific exercises for 30 minutes twice a day without fatigue carrying the lymphedema sleeve for at least 12 hours. If after three months of treatment a good response is not obtained an ambulatory treatment will be introduced again for one month,and this time the treatment corresponding to the group B or experimental will be applied. |
| GroupB | Experimental | Other: Manual Lymph Drainage (MLD) and Compression BandagingAmbulatory treatment is carried out during one month. Specific exercises measures of prevention are taught. MLD is carried out followed by a daily multilayer bandage during the first four weeks. The tailor-made sleeve for lymphedema with gauntlet without protection at the edges and with extension to the shoulder is placed from the first four weeks of treatment. The sleeve is used during the whole day and a night interruption is allowed. Later the patient will continue domiciliary treatment realizing specific exercises for 30 minutes twice a day without fatigue carrying the lymphedema sleeve for at least 12 hours. If after three months of treatment a good response is not obtained an ambulatory treatment will be introduced again for one month, and this time the treatment corresponding to the group A or Control will be applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- women older than 18 years, intervented of unilateral breast neoplasia with ipsilateral axillar lymphadenectomy
- Patients with ipsilateral lymphoedema with a volume difference of at least 200ml compared to the lateral limb
- Patients who have finished the treatment with Radiotherapy and / or chemotherapy at least six months before the study started
- Informed acceptance has to be signed
Key exclusion criteria (7 listed)
- Bilateral affectation of both extremities.
- Malignant Active disease
- Acute Lymphoedema (in the first three months postintervention)
- Patients with previous paralysis or vascular alteration in the affected arm
- Patients with a major limitation of 30 º in any of the arches of movement of the ipsilateral shoulder
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 |
|---|---|---|
| Compression BandagingGroup A or Control Group: ambulatory treatment is performed during one month. Specific exercises and prevention measures are taught. The tailor-made sleeve for lymphedema with gauntlet without protection at the edges and with extension to the shoulder is placed from the first four weeks of treatment. The sleeve is used during the whole day and a night interruption is allowed. Later the patient will continue domiciliary treatment realizing specific exercises for 30 minutes twice a day without fatigue carrying the lymphedema sleeve for at least 12 hours. If after three months of treatment a good response is not obtained an ambulatory treatment will be introduced again for one month,and this time the treatment corresponding to the group B or experimental will be applied. | Other | GroupA |
| Manual Lymph Drainage (MLD) and Compression BandagingSpecific exercises measures of prevention are taught. MLD is carried out followed by a daily multilayer bandage during the first four weeks. The tailor-made sleeve for lymphedema with gauntlet without protection at the edges and with extension to the shoulder is placed from the first four weeks of treatment. The sleeve is used during the whole day and a night interruption is allowed. Later the patient will continue domiciliary treatment realizing specific exercises for 30 minutes twice a day without fatigue carrying the lymphedema sleeve for at least 12 hours. If after three months of treatment a good response is not obtained an ambulatory treatment will be introduced again for one month, and this time the treatment corresponding to the group A or Control will be applied. | Other | GroupB |
Primary outcome
Statistical analysis
Time frame: 1 year after the clinical trial ends
All the patients included in the study will be analyzed and all the analyses will be performed for " intention of treating " except that related to the withdrawal of the treatment that will be done by protocol. Firstly an analysis of comparability of the groups using the test of the T de Student or Mann-Withney's Test and test of Fischer´s exact test will be performed. Efficacy analysis:means differences and / or reason of medians for the quantitative variables and reason of risks and NNT for the quantitative variables.
1 secondary outcome
Statistical analysis
Time frame: 1 year after the clinical trial ends
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
- Background: PubMed 12704719Kopanski Z, Wojewoda T, Wojewoda A, Schlegel-Zawadzka M, Wozniacka R, Suder A, Kosciuk T. Influence of some anthropometric parameters on the risk of development of distal complications after mastectomy carried out because of breast carcinoma. Am J Hum Biol. 2003 May-Jun;15(3):433-9. doi: 10.1002/ajhb.10158.
- Background: PubMed 9664269Johansson K, Lie E, Ekdahl C, Lindfeldt J. A randomized study comparing manual lymph drainage with sequential pneumatic compression for treatment of postoperative arm lymphedema. Lymphology. 1998 Jun;31(2):56-64.
- Background: PubMed 10870068Badger CM, Peacock JL, Mortimer PS. A randomized, controlled, parallel-group clinical trial comparing multilayer bandaging followed by hosiery versus hosiery alone in the treatment of patients with lymphedema of the limb. Cancer. 2000 Jun 15;88(12):2832-7.
- Background: PubMed 10987238Andersen L, Hojris I, Erlandsen M, Andersen J. Treatment of breast-cancer-related lymphedema with or without manual lymphatic drainage--a randomized study. Acta Oncol. 2000;39(3):399-405. doi: 10.1080/028418600750013186.
- Background: PubMed 11332311Harris SR, Hugi MR, Olivotto IA, Levine M; Steering Committee for Clinical Practice Guidelines for the Care and Treatment of Breast Cancer. Clinical practice guidelines for the care and treatment of breast cancer: 11. Lymphedema. CMAJ. 2001 Jan 23;164(2):191-9.
- Background: PubMed 2751222Foldi E, Foldi M, Clodius L. The lymphedema chaos: a lancet. Ann Plast Surg. 1989 Jun;22(6):505-15. doi: 10.1097/00000637-198906000-00007.
- Background: PubMed 10587190Ramos SM, O'Donnell LS, Knight G. Edema volume, not timing, is the key to success in lymphedema treatment. Am J Surg. 1999 Oct;178(4):311-5. doi: 10.1016/s0002-9610(99)00185-3.
- Background: PubMed 15319562McNeely ML, Magee DJ, Lees AW, Bagnall KM, Haykowsky M, Hanson J. The addition of manual lymph drainage to compression therapy for breast cancer related lymphedema: a randomized controlled trial. Breast Cancer Res Treat. 2004 Jul;86(2):95-106. doi: 10.1023/B:BREA.0000032978.67677.9f.
- Background: PubMed 15495042Badger C, Preston N, Seers K, Mortimer P. Physical therapies for reducing and controlling lymphoedema of the limbs. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD003141. doi: 10.1002/14651858.CD003141.pub2.
- Derived from this study: PubMed 21392372Martin ML, Hernandez MA, Avendano C, Rodriguez F, Martinez H. Manual lymphatic drainage therapy in patients with breast cancer related lymphoedema. BMC Cancer. 2011 Mar 9;11:94. doi: 10.1186/1471-2407-11-94.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compression Bandaging and Manual Lymph Drainage (MLD) and Compression Bandaging in people with Lymphoedema, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 27 Feb 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Statistical analysis (time frame: 1 year after the clinical trial ends). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01152099, which also lists 10 linked publications.
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 27 Feb 2018.