Breast Cancer LymphedemaNCT06569719
Effectiveness of CDT for the Treatment of Lymphedema in Breast Cancer Patients Who Received LVA Surgery
A study testing Complex decongestive therapy in people with Breast Cancer Lymphedema, run by Fundacion Universitaria Maria Cano at 2 sites in Colombia.
Trial summary
Breast cancer is the most common type of cancer in women worldwide. Advances in treatment have increased survival rates, so patients must live with the complications resulting from the cancer and its treatment. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Breast Cancer Lymphedema
- What is being tested?
- Complex decongestive therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesColombia
- Study dates
- 1 Feb 2024to 30 Dec 2024
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with lymphedema due to cancer.
- Patients who have undergone lymphovenous anastomosis surgery in the past 12 months
Who cannot join
- Decompensated heart failure
- Decompensated renal failure
- Open wounds
- Decompensated arterial insufficiencies
Trial locations and contacts
2 sites in 1 country.
Colombia2 sites
Fundación Universitaria María Cano
Medellín, Antioquia, 0000
Fundación Universitaria María cano
Medellín, Antioquia, 05000
About this study
Official title: Effectiveness of Complex Decongestive Therapy for the Treatment of Lymphedema in Breast Cancer Patients Who Received Lymphovenous Anastomosis Surgery: a Pilot Study
Breast cancer is the most common type of cancer in women worldwide. Advances in treatment have increased survival rates, so patients must live with the complications resulting from the cancer and its treatment. One of the most common side effects is lymphedema, which can occur as a secondary effect of surgical or radiotherapy treatment. Lymphatic edema is a condition characterized by an excess of lymphatic fluid, rich in proteins, in the subcutaneous tissue, causing pain, a feeling of heaviness in the affected limb, restricted range of motion, and, in some cases, progressing to the formation of ulcers and recurrent infections; inevitably affecting the quality of life of the women who suffer from it. There are various therapeutic strategies to reduce the risk of developing lymphedema or to treat it. Among the management options is complex decongestive therapy (CDT), which is a conservative treatment that includes manual lymphatic drainage (MLD), compression therapy, skin care, and lymph-reducing exercises (LRE). Surgical options include lymph node transfer and lymphovenous anastomosis; redirecting lymphatic circulation and reducing edema in the affected limb. This is why the current research is undertaken, aiming to evaluate the effectiveness of combining these two treatment approaches in terms of reducing lymphedema, the presence of cellulitis, and changes in patients' quality of life
Read the detailed description
Breast cancer is the most common type of cancer among women, with an estimated 2.3 million new cases diagnosed worldwide in 2020, with especially high incidence in developed countries. The five-year survival rate for breast cancer exceeds 90%, and the average ten-year survival rate for women with non-metastatic invasive breast cancer is 84% (Ferlay et al., 2021).
As a consequence, there is an increasing number of women facing early and late side effects from breast cancer treatment. One of the most common side effects is lymphedema, with a reported incidence after cancer treatment around 30% (Martínez Jaimez, 2017). In Colombia, it is estimated that 28% of women who undergo lymphadenectomy develop lymphedema (Valencia Legarda et al., 2020). Lymphedema is a chronic inflammatory disease that affects approximately 250 million people worldwide, mostly associated with cancer treatment. It can occur as a result of breast cancer surgery and/or radiotherapy (Riady-Aleuy et al., 2022). Lymphedema is defined as the accumulation of protein-rich fluid in the interstitium, secondary to abnormalities in the lymphatic transport system.
According to the impact of lymphedema on the quality of life of individuals, as well as the associated social and economic costs, efforts must be made to prevent and treat it. Various conservative strategies are used to reduce the risk of developing lymphedema and to manage it once it has developed. Among the physiotherapeutic options is complex decongestive therapy (CDT), which is a conservative treatment that includes manual lymphatic drainage (MLD), compression therapy (consisting of compression bandages, compression sleeves, or other types of compression garments), skin care, and lymph-reducing exercises (LRE).
Another treatment option is surgery, which has traditionally been considered a last resort when conservative measures have failed. However, increasingly advanced surgical interventions are now being performed early in the disease process, with the hope of preventing or reversing edema that arises from impaired lymphatic flow (Markkula et al., 2019). These interventions include liposuction, lymph node transfer, and lymphaticovenular anastomosis (LVA). The latter was first described in 1960, but it wasn't until 1989 in Japan and in 2020 in Colombia that it became the gold standard of microsurgery, emerging as an innovative technique in our field, increasingly used as a treatment for lymphedema rather than as a last-resort strategy when other treatments have failed (Gupta et al., 2021).
- Conditions
- Breast Cancer Lymphedema
- Being tested
- Complex decongestive therapy
- Medical subject headings
- Breast Cancer Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex decongestive therapyOther
Includes manual lymphatic drainage (MLD), compression therapy (which consists of compression bandages, compression sleeves, or other types of compression garments), skin care, and lymph-reducing exercises
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients who have recieved lymphovenous anastomosis in the past 12 months and participates in complex decongestive therapy (CDT), including all its techniques, consisting of a total of 10 therapy sessions and a follow-up at 3 months Receives: Other: Complex decongestive therapy |
| Control | No intervention | Patients received lymphovenous anastomosis and they are provided with compression garments as part of the treatment withot recieving CDT . This group will have an initial assessment and follow-up at 3 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymphedema change
Upper and leg Extremity Lymphedema Index. The index includes 5 perimeters that are sum and divided by BMI. Classified as mild leg lymphedema < 250, mild to severe 250-350 and severe > 350. Classified as mild arm lymphedema < 130, mild to severe 130-150 and severe > 150 This outcome is compound by multiple measurements that will be aggregated to arrive at one reported.
Measured: Baseline, post-intervention up to 3 weeks and 3 months follow up
Secondary outcomes (1)
Quality of life change
ARM and LEG Lymphoedema Quality of Life Tool (LYMQOL). It includes 3 domains (Function, symptoms, mood) and an overall quality of life score. Domain totals are calculated by adding the individual scores and dividing the total by the number of questions answered. A higher number means a poor quality of life.
Measured: Baseline, post-intervention up to 3 weeks and 3 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start1 Feb 2024
- Primary completion14 Aug 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer LymphedemaStudies 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
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Universitaria Maria Cano
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catalina Lopera Muñetón, Advanced Bionics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569719
- Sponsor's protocol ID
- 013008013-2023-311
- Status last verified
- Jan 2025
- First submitted
- 14 Aug 2024
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in cancer lymphedema. Data or samples shared will be coded. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Complex Decongestive Therapy for the Treatment of Lymphedema in Breast Cancer Patients Who Received Lymphovenous Anastomosis Surgery: a Pilot Study
- ClinicalTrials.gov ID
- NCT06569719
- Acronym / sponsor ID
- 013008013-2023-311
- Conditions
- Breast Cancer Lymphedema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Fundacion Universitaria Maria CanoUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 14 Aug 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 26 Aug 2024 (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.
Breast cancer is the most common type of cancer in women worldwide. Advances in treatment have increased survival rates, so patients must live with the complications resulting from the cancer and its treatment. One of the most common side effects is lymphedema, which can occur as a secondary effect of surgical or radiotherapy treatment. Lymphatic edema is a condition characterized by an excess of lymphatic fluid, rich in proteins, in the subcutaneous tissue, causing pain, a feeling of heaviness in the affected limb, restricted range of motion, and, in some cases, progressing to the formation of ulcers and recurrent infections; inevitably affecting the quality of life of the women who suffer from it. There are various therapeutic strategies to reduce the risk of developing lymphedema or to treat it. Among the management options is complex decongestive therapy (CDT), which is a conservative treatment that includes manual lymphatic drainage (MLD), compression therapy, skin care, and lymph-reducing exercises (LRE). Surgical options include lymph node transfer and lymphovenous anastomosis; redirecting lymphatic circulation and reducing edema in the affected limb. This is why the current research is undertaken, aiming to evaluate the effectiveness of combining these two treatment approaches in terms of reducing lymphedema, the presence of cellulitis, and changes in patients' quality of life
Detailed description
Breast cancer is the most common type of cancer among women, with an estimated 2.3 million new cases diagnosed worldwide in 2020, with especially high incidence in developed countries. The five-year survival rate for breast cancer exceeds 90%, and the average ten-year survival rate for women with non-metastatic invasive breast cancer is 84% (Ferlay et al., 2021).
As a consequence, there is an increasing number of women facing early and late side effects from breast cancer treatment. One of the most common side effects is lymphedema, with a reported incidence after cancer treatment around 30% (Martínez Jaimez, 2017). In Colombia, it is estimated that 28% of women who undergo lymphadenectomy develop lymphedema (Valencia Legarda et al., 2020). Lymphedema is a chronic inflammatory disease that affects approximately 250 million people worldwide, mostly associated with cancer treatment. It can occur as a result of breast cancer surgery and/or radiotherapy (Riady-Aleuy et al., 2022). Lymphedema is defined as the accumulation of protein-rich fluid in the interstitium, secondary to abnormalities in the lymphatic transport system.
According to the impact of lymphedema on the quality of life of individuals, as well as the associated social and economic costs, efforts must be made to prevent and treat it. Various conservative strategies are used to reduce the risk of developing lymphedema and to manage it once it has developed. Among the physiotherapeutic options is complex decongestive therapy (CDT), which is a conservative treatment that includes manual lymphatic drainage (MLD), compression therapy (consisting of compression bandages, compression sleeves, or other types of compression garments), skin care, and lymph-reducing exercises (LRE).
Another treatment option is surgery, which has traditionally been considered a last resort when conservative measures have failed. However, increasingly advanced surgical interventions are now being performed early in the disease process, with the hope of preventing or reversing edema that arises from impaired lymphatic flow (Markkula et al., 2019). These interventions include liposuction, lymph node transfer, and lymphaticovenular anastomosis (LVA). The latter was first described in 1960, but it wasn't until 1989 in Japan and in 2020 in Colombia that it became the gold standard of microsurgery, emerging as an innovative technique in our field, increasingly used as a treatment for lymphedema rather than as a last-resort strategy when other treatments have failed (Gupta et al., 2021).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Complex decongestive therapyPatients who have recieved lymphovenous anastomosis in the past 12 months and participates in complex decongestive therapy (CDT), including all its techniques, consisting of a total of 10 therapy sessions and a follow-up at 3 months |
| Control | No intervention | –Patients received lymphovenous anastomosis and they are provided with compression garments as part of the treatment withot recieving CDT . This group will have an initial assessment and follow-up at 3 months |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with lymphedema due to cancer.
- Patients who have undergone lymphovenous anastomosis surgery in the past 12 months
Key exclusion criteria (4 listed)
- Decompensated heart failure
- Decompensated renal failure
- Open wounds
- Decompensated arterial insufficiencies
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 |
|---|---|---|
| Complex decongestive therapyIncludes manual lymphatic drainage (MLD), compression therapy (which consists of compression bandages, compression sleeves, or other types of compression garments), skin care, and lymph-reducing exercises | Other | Intervention |
Primary outcome
Lymphedema change
Time frame: Baseline, post-intervention up to 3 weeks and 3 months follow up
Upper and leg Extremity Lymphedema Index. The index includes 5 perimeters that are sum and divided by BMI. Classified as mild leg lymphedema < 250, mild to severe 250-350 and severe > 350. Classified as mild arm lymphedema < 130, mild to severe 130-150 and severe > 150 This outcome is compound by multiple measurements that will be aggregated to arrive at one reported.
1 secondary outcome
Quality of life change
Time frame: Baseline, post-intervention up to 3 weeks and 3 months follow up
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 17 Jan 2025.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in cancer lymphedema. Data or samples shared will be coded. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complex decongestive therapy in people with Breast Cancer Lymphedema, run by Fundacion Universitaria Maria Cano at 2 sites in Colombia.
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 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Colombia. 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?
Lymphedema change (time frame: Baseline, post-intervention up to 3 weeks and 3 months follow up). 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 Jan 2025.