Breast CancerNCT04112966
Lymphedema Prevention in Breast Cancer
A study testing 14 sessions of manual lymphatic drainage technique and the health education in people with Breast Cancer and Lymphedema, run by University of Castilla-La Mancha at 1 site in Spain.
Trial summary
OBJECTIVE: To find out the effectiveness of early application of Manual Lymph Drainage in the prevention of upper limb lymphedema after breast surgery and axillary lymphadenectomy in women with breast cancer. DESIGN: Randomized, controlled and single blinded clinical trial. Five years duration. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Breast Cancer, Lymphedema
- What is being tested?
- 14 sessions of manual lymphatic drainage technique and the health education
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- May 2004to Oct 2016
- 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 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of breast cancer.
- Undergoing unilateral surgery with axillary lymph-node dissection.
Who cannot join
- Bilateral breast cancer.
- Systemic disease.
- Locoregional recurrence.
- Any contraindication to physical therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Manual Lymph Drainage in the Prevention of Lymphedema Related to Breast Cancer
OBJECTIVE: To find out the effectiveness of early application of Manual Lymph Drainage in the prevention of upper limb lymphedema after breast surgery and axillary lymphadenectomy in women with breast cancer.
DESIGN: Randomized, controlled and single blinded clinical trial. Five years duration. Patients were randomly assigned to one of these groups: Experimental group: Manual Lymph Drainage + training in means of prevention; Control group: just training in means of prevention. In both groups several physical therapy assessments were undertaken: 1st before surgery; 2nd 3 month after surgery; 4th, 5th, 6th, 7th, 8th and 9th after 6, 12, 24, 36, 48 and 60 months.
Read more
SUBJECTS: Women with breast cancer treated with breast surgery including axillary lymphadenectomy in Provincial Hospital of Toledo, provided that there is no contraindication for manual lymph drainage, and after reading, understanding and freely signing an informed consent form.
SAMPLE SIZE: A total of 150 subjects were included in the study (57 subjects in experimental group and 93 in control group), assuming a 20% of drop-outs and at least 25% reduction, with a statistical power of 75%.
DATA ANALYSIS: To find out the effectiveness of intervention the investigators will compare the rate of lymphedema in both groups by means of a logistic regression analysis, in which the main factor is the intervention group. Other factors aimed to control the effect of the intervention will also be included. In order to compare the rate of appearance of lymphedema in both groups, a survival analysis will also be included.
- Conditions
- Breast Cancer, Lymphedema
- Being tested
- 14 sessions of manual lymphatic drainage technique, the health education
- Keywords
- Lymphedema, Prevention
- Medical subject headings
- Breast Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14 sessions of manual lymphatic drainage techniqueProcedure or surgery
Early manual lymph drainage including 14 sessions of manual lymphatic drainage technique in the three months following surgery and health education for lymphedema prevention including verbal instructions and written materials.
the health educationOther
The health education for lymphedema prevention.
| Study group | Role | What they receive |
|---|---|---|
| Early Manual Lymph Drainage | Experimental | 14 sessions of manual lymphatic drainage technique in the three months following surgery and received health education on the prevention of lymphedema. Receives: Procedure: 14 sessions of manual lymphatic drainage technique; Other: the health education |
| Health education for lymphedema prevention | Other | Only the health education for lymphedema prevention. Receives: Other: the health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circumference measurements
Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization.
Measured: 0 months
Circumference measurements
Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization and then post-operatively on 3 months after surgery.
Measured: 3 months
Circumference measurements
Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization and then post-operatively on 6 months after surgery.
Measured: 6 months
Circumference measurements
Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization and then post-operatively on 12 months after surgery.
Measured: 12 months
Circumference measurements
Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization and then post-operatively on 24 months after surgery.
Measured: 24 months
Circumference measurements
Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization and then post-operatively on 36 months after surgery.
Measured: 36 months
Circumference measurements
Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization and then post-operatively on 48 months after surgery.
Measured: 48 months
Circumference measurements
Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization and then post-operatively on 60 months after surgery.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study startMay 2004
- Primary completionOct 2011
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Collaborators
- Castilla-La Mancha Health Service
- Responsible party
- Sponsor
- Investigators
- Helena Romay Barrero, Prof. PhD., Principal investigator, University of Castilla-La Mancha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112966
- Sponsor's protocol ID
- ECA-DLM-5
- Status last verified
- Oct 2019
- First submitted
- 22 Jul 2019
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual Lymph Drainage in the Prevention of Lymphedema Related to Breast Cancer
- ClinicalTrials.gov ID
- NCT04112966
- Acronym / sponsor ID
- ECA-DLM-5
- Conditions
- Breast Cancer, Lymphedema
- Keywords
- Lymphedema, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Collaborators
- Castilla-La Mancha Health Service
- Study start
- May 2004 (actual)
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 2 Oct 2019 (actual)
- 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.
OBJECTIVE: To find out the effectiveness of early application of Manual Lymph Drainage in the prevention of upper limb lymphedema after breast surgery and axillary lymphadenectomy in women with breast cancer.
DESIGN: Randomized, controlled and single blinded clinical trial. Five years duration. Patients were randomly assigned to one of these groups: Experimental group: Manual Lymph Drainage + training in means of prevention; Control group: just training in means of prevention. In both groups several physical therapy assessments were undertaken: 1st before surgery; 2nd 3 month after surgery; 4th, 5th, 6th, 7th, 8th and 9th after 6, 12, 24, 36, 48 and 60 months.
SUBJECTS: Women with breast cancer treated with breast surgery including axillary lymphadenectomy in Provincial Hospital of Toledo, provided that there is no contraindication for manual lymph drainage, and after reading, understanding and freely signing an informed consent form.
SAMPLE SIZE: A total of 150 subjects were included in the study (57 subjects in experimental group and 93 in control group), assuming a 20% of drop-outs and at least 25% reduction, with a statistical power of 75%.
DATA ANALYSIS: To find out the effectiveness of intervention the investigators will compare the rate of lymphedema in both groups by means of a logistic regression analysis, in which the main factor is the intervention group. Other factors aimed to control the effect of the intervention will also be included. In order to compare the rate of appearance of lymphedema in both groups, a survival analysis will also be included.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Manual Lymph Drainage | Experimental | Procedure: 14 sessions of manual lymphatic drainage technique, Other: the health education14 sessions of manual lymphatic drainage technique in the three months following surgery and received health education on the prevention of lymphedema. |
| Health education for lymphedema prevention | Other | Other: the health educationOnly the health education for lymphedema prevention. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of breast cancer.
- Undergoing unilateral surgery with axillary lymph-node dissection.
Key exclusion criteria (4 listed)
- Bilateral breast cancer.
- Systemic disease.
- Locoregional recurrence.
- Any contraindication to physical therapy.
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 |
|---|---|---|
| 14 sessions of manual lymphatic drainage techniqueEarly manual lymph drainage including 14 sessions of manual lymphatic drainage technique in the three months following surgery and health education for lymphedema prevention including verbal instructions and written materials. | Procedure or surgery | Early Manual Lymph Drainage |
| the health educationThe health education for lymphedema prevention. | Other | Early Manual Lymph Drainage, Health education for lymphedema prevention |
Primary outcome
Circumference measurements
Time frame: 0 months
Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization.
Circumference measurements
Time frame: 3 months
Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization and then post-operatively on 3 months after surgery.
Circumference measurements
Time frame: 6 months
Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization and then post-operatively on 6 months after surgery.
Circumference measurements
Time frame: 12 months
Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization and then post-operatively on 12 months after surgery.
Circumference measurements
Time frame: 24 months
Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization and then post-operatively on 24 months after surgery.
Circumference measurements
Time frame: 36 months
Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization and then post-operatively on 36 months after surgery.
Circumference measurements
Time frame: 48 months
Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization and then post-operatively on 48 months after surgery.
Circumference measurements
Time frame: 60 months
Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization and then post-operatively on 60 months after surgery.
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 2 Oct 2019.
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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.
Helena Romay Barrero, Prof. PhD. principal investigator
University of Castilla-La Mancha
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 14 sessions of manual lymphatic drainage technique and the health education in people with Breast Cancer and Lymphedema, run by University of Castilla-La Mancha 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 4 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 2 Oct 2019. 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?
Circumference measurements (time frame: 0 months). The study lists 8 primary outcomes in all. 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 2 Oct 2019.