Breast CancerPRELUDENCT04579029
PRELUDE Study of Lymphatic Surgery to Treat Breast Cancer Related Lymphoedema
A study testing Lymphaticovenous anastomosis surgery combined with near infrared spectroscopy imaging in people with Breast Cancer and Lymphedema, run by Royal Marsden NHS Foundation Trust at 2 sites in United Kingdom.
Trial summary
Lymphoedema is a chronic debilitating disease that can have severe adverse effects on day-to-day life causing great physical and visual discomfort. The clinical presentation is characterised by chronic swelling of limbs, accompanied by localised pain, skin changes and recurrent infections. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Lymphedema
- What is being tested?
- Lymphaticovenous anastomosis surgery combined with near infrared spectroscopy imaging
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 13 Oct 2021to Apr 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Breast cancer patients treated with axillary surgery who have developed post-surgical lymphoedema (increase in limb volume by >10% for 1 month or longer)
- Patients must have completed their adjuvant therapy (excluding hormonal/long term Rx)
- Patients must be within 6 months of having developed documented lymphoedema
Who cannot join
- • Contraindications to the use of the contrast agent (iodine allergy / untreated hypothyroidism)
- Near infra-red spectroscopy providing insufficient data to guide surgery or evidence of LVA incompatibility (As these patients will be have only just developed lymphoedema, they are by definition very early in the spectrum of disease progression. Thus, the chances of all superficial lymphatics deteriorating to the extent that LVA surgery is not possible is extremely low - <1% we expect).
- Inability to give informed consent or cooperate with assessment procedures and follow-up because of cognitive or physical impairments
- Medical co-morbidities increasing the risk of general anaesthetic (significant cardiac / respiratory disease)
- Recurrent, metastatic or progressive disease, defined by oncology team on basis of clinical assessment or imaging
- Evidence of pre-existing / primary lymphoedema on clinical history or lymphoscintigraphy
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Mark Brandon-Grove
London, SW3 6JJ
Mark Brandon-Grove, 02031865416, Mark.Brandon-Grove@rmh.nhs.uk
- Recruiting
Mark Brandon-Grove
Sutton, Surrey, SM2 5PT
Mark Brandon-Grove, 02031865416, Mark.Brandon-Grove@rmh.nhs.uk
About this study
Official title: Prospective Randomized Evaluation of Lymphaticovenous Anastomosis Using Dynamic Imaging in Breast Cancer-related Lymphoedema
Lymphoedema is a chronic debilitating disease that can have severe adverse effects on day-to-day life causing great physical and visual discomfort. The clinical presentation is characterised by chronic swelling of limbs, accompanied by localised pain, skin changes and recurrent infections. It is caused by a disruption in lymphatic flow which prevents the normal circulation of interstitial fluid (situated in the spaces between the cells of the body), resulting in swelling of the affected limb. It can be primary (cause unknown) or secondary to a number of causes such as malignancy, trauma, surgery, radiotherapy, infection, or venous disease.
In breast cancer treatment, axillary surgery and radiotherapy significantly damage normal lymphatic drainage of the upper limb, causing lymphoedema in 1-in-5 patients.
Read more
There is a growing body of evidence that this chronic and debilitating condition can be better managed through early surgical intervention rather than the current conservative management, which rely on pressure garments and massage. This surgical intervention, lymphaticovenous anastomosis (LVA), joins up a number of the draining lymphatic vessels to correspondingly sized veins on the affected limb using microsurgical techniques. A special dye and camera system is used to facilitate identifying lymph vessels. This creates a new drainage pathway for the lymph fluid around the area of disruption, improving lymphatic flow. Volume reduction is expected and this would be expected to provide quality of life benefits for the patients.
This study seeks to compare the outcomes from both therapies and determine whether LVA surgery can help to improve the physical burden and quality of life for patients affected by lymphoedema. Furthermore, lymphoedema places a substantial burden on NHS services. If this trial is successful, LVA surgery could improve patient outcomes and reduce the overall cost of treatment.
- Conditions
- Breast Cancer, Lymphedema
- Being tested
- Lymphaticovenous anastomosis surgery combined with near infrared spectroscopy imaging
- 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.
Lymphaticovenous anastomosis surgery combined with near infrared spectroscopy imagingProcedure or surgery
Lymphoedema is well recognized as a chronic debilitating disease resulting from an abnormal collection of protein-rich fluid within the subcutaneous tissues of the body. Given the need to identify more effective treatments, more recent advances in super microsurgical techniques have seen the introduction of new procedures, perhaps the most successful of which have involved re-routing the lymphatic fluid by using microsurgery to divert small lymphatic channels into venules in the sub-dermal plane (LVA surgery). This procedure is performed under regional or general anaesthetic as a day-case operation, leaving only a few very short scars in the skin of the arm or leg.
| Study group | Role | What they receive |
|---|---|---|
| Surgical Cohort | Experimental | Patients randomised to the surgical group will undergo near infrared spectroscopy imaging to assess suitability and plan the surgical procedure.
Limb measurements with perometry and bio-impedance spectroscopy will be performed at baseline. Under general anaesthetic multiple LVA bypass procedures will be performed on the affected arm. Near infrared spectroscopy imaging will be used throughout. One week after discharge the patient will return for the bandages to be removed and the wounds inspected for any evidence of infection before renewing the bandage. Again, two weeks after surgery, the patient will return for inspection of wound and removal of sutures. It is at this point that the surgical patients will be returned into a standard lymphoedema compression garment, fitted by the research nurse. Thereafter, standard follow up (Bilateral) measurements and checks will be done at 1 month, 3 months, 6 months and 1 year. Receives: Procedure: Lymphaticovenous anastomosis surgery combined with near infrared spectroscopy imaging |
| Non-surgical cohort | No intervention | The main intervention for the non-surgical group largely encompasses limb measurements with perometry and bio-impedance spectroscopy at baseline before a compression garment is applied. The compression garments will be measured and fitted by a trained lymphoedema specialist and will be given the standard advice as is best practice for such patients currently. This cohort will likewise be followed up at 1 month, 3 months, 6 months and 1 year and undergo perometry readings and measurements with comparable collection of data. For patients in both surgical and non-surgical groups, the compression garments will be measured and fitted by a trained lymphoedema specialist and they will be given the standard advice as is best practice for such patients currently. For each patient key details of the surgical technique, garment specification, imaging results and perometry/BIS measurements will be recorded on a study specific form for subsequent entry onto the database. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean excess volume reduction - compared between two cohorts
Primary outcome measure is to evaluate the efficacy of LVA surgery (combined with CGT) by comparison of arm volume measurements across both the surgical and the control group at set time points post-surgery). This will be performed using the mean excess volume reduction (EVR) as a percentage change at 12 months - measured with perometry.
Measured: 12 months from recruitment
Secondary outcomes (5)
Safety - infection and surgical complications
Assess the safety of LVA surgery (supported by PDE imaging guidance) by recording incidence of infection and post-operative complications.
Measured: 12 months from recruitment
Bio-impedance spectroscopy
Compare changes in bio-impedance spectroscopy during the period of the study
Measured: 12 months from recruitment
Cellulitis
Compare the incidence of cellulitis in both groups within the 12-month study period
Measured: 12 months from recruitment
Quality of life - LYMQOL score
Compare longer term Quality of Life (QOL) in both groups using a quality of life assessment tool for lymphoedema of the limbs (LYMQOL) completed by patients. Multiple questions covering function, appearance, symptoms and mood are asked, with a quality of life score for each between 1 and 4. Total score 16 (higher score = poorer quality of life)
Measured: 12 months from recruitment
Compliance
Compliance with use of compression therapy during the study.
Measured: 12 months from recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start13 Oct 2021
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
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.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- 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
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579029
- Sponsor's protocol ID
- CCR4772
- Acronym
- PRELUDE
- Status last verified
- Jan 2023
- First submitted
- 1 Oct 2020
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Evaluation of Lymphaticovenous Anastomosis Using Dynamic Imaging in Breast Cancer-related Lymphoedema
- ClinicalTrials.gov ID
- NCT04579029
- Acronym / sponsor ID
- PRELUDE / CCR4772
- Conditions
- Breast Cancer, Lymphedema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- 13 Oct 2021 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 8 Oct 2020 (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.
Lymphoedema is a chronic debilitating disease that can have severe adverse effects on day-to-day life causing great physical and visual discomfort. The clinical presentation is characterised by chronic swelling of limbs, accompanied by localised pain, skin changes and recurrent infections. It is caused by a disruption in lymphatic flow which prevents the normal circulation of interstitial fluid (situated in the spaces between the cells of the body), resulting in swelling of the affected limb. It can be primary (cause unknown) or secondary to a number of causes such as malignancy, trauma, surgery, radiotherapy, infection, or venous disease.
In breast cancer treatment, axillary surgery and radiotherapy significantly damage normal lymphatic drainage of the upper limb, causing lymphoedema in 1-in-5 patients.
There is a growing body of evidence that this chronic and debilitating condition can be better managed through early surgical intervention rather than the current conservative management, which rely on pressure garments and massage. This surgical intervention, lymphaticovenous anastomosis (LVA), joins up a number of the draining lymphatic vessels to correspondingly sized veins on the affected limb using microsurgical techniques. A special dye and camera system is used to facilitate identifying lymph vessels. This creates a new drainage pathway for the lymph fluid around the area of disruption, improving lymphatic flow. Volume reduction is expected and this would be expected to provide quality of life benefits for the patients.
This study seeks to compare the outcomes from both therapies and determine whether LVA surgery can help to improve the physical burden and quality of life for patients affected by lymphoedema. Furthermore, lymphoedema places a substantial burden on NHS services. If this trial is successful, LVA surgery could improve patient outcomes and reduce the overall cost of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical Cohort | Experimental | Procedure: Lymphaticovenous anastomosis surgery combined with near infrared spectroscopy imagingPatients randomised to the surgical group will undergo near infrared spectroscopy imaging to assess suitability and plan the surgical procedure. Limb measurements with perometry and bio-impedance spectroscopy will be performed at baseline. Under general anaesthetic multiple LVA bypass procedures will be performed on the affected arm. Near infrared spectroscopy imaging will be used throughout. One week after discharge the patient will return for the bandages to be removed and the wounds inspected for any evidence of infection before renewing the bandage. Again, two weeks after surgery, the patient will return for inspection of wound and removal of sutures. It is at this point that the surgical patients will be returned into a standard lymphoedema compression garment, fitted by the research nurse. Thereafter, standard follow up (Bilateral) measurements and checks will be done at 1 month, 3 months, 6 months and 1 year. |
| Non-surgical cohort | No intervention | –The main intervention for the non-surgical group largely encompasses limb measurements with perometry and bio-impedance spectroscopy at baseline before a compression garment is applied. The compression garments will be measured and fitted by a trained lymphoedema specialist and will be given the standard advice as is best practice for such patients currently. This cohort will likewise be followed up at 1 month, 3 months, 6 months and 1 year and undergo perometry readings and measurements with comparable collection of data. For patients in both surgical and non-surgical groups, the compression garments will be measured and fitted by a trained lymphoedema specialist and they will be given the standard advice as is best practice for such patients currently. For each patient key details of the surgical technique, garment specification, imaging results and perometry/BIS measurements will be recorded on a study specific form for subsequent entry onto the database. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Breast cancer patients treated with axillary surgery who have developed post-surgical lymphoedema (increase in limb volume by >10% for 1 month or longer)
- Patients must have completed their adjuvant therapy (excluding hormonal/long term Rx)
- Patients must be within 6 months of having developed documented lymphoedema
Key exclusion criteria (6 listed)
- • Contraindications to the use of the contrast agent (iodine allergy / untreated hypothyroidism)
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 |
|---|---|---|
| Lymphaticovenous anastomosis surgery combined with near infrared spectroscopy imagingLymphoedema is well recognized as a chronic debilitating disease resulting from an abnormal collection of protein-rich fluid within the subcutaneous tissues of the body. Given the need to identify more effective treatments, more recent advances in super microsurgical techniques have seen the introduction of new procedures, perhaps the most successful of which have involved re-routing the lymphatic fluid by using microsurgery to divert small lymphatic channels into venules in the sub-dermal plane (LVA surgery). This procedure is performed under regional or general anaesthetic as a day-case operation, leaving only a few very short scars in the skin of the arm or leg. | Procedure or surgery | Surgical Cohort |
Primary outcome
Mean excess volume reduction - compared between two cohorts
Time frame: 12 months from recruitment
Primary outcome measure is to evaluate the efficacy of LVA surgery (combined with CGT) by comparison of arm volume measurements across both the surgical and the control group at set time points post-surgery). This will be performed using the mean excess volume reduction (EVR) as a percentage change at 12 months - measured with perometry.
5 secondary outcomes
Safety - infection and surgical complications
Time frame: 12 months from recruitment
Bio-impedance spectroscopy
Time frame: 12 months from recruitment
Cellulitis
Time frame: 12 months from recruitment
Quality of life - LYMQOL score
Time frame: 12 months from recruitment
Compliance
Time frame: 12 months from recruitment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lymphaticovenous anastomosis surgery combined with near infrared spectroscopy imaging in people with Breast Cancer and Lymphedema, run by Royal Marsden NHS Foundation Trust at 2 sites in United Kingdom.
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 3 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 18 Jan 2023. 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 United Kingdom. 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 Kelvin WD Ramsey, FRCS(Plast) (02078082208, Kelvin.Ramsey@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean excess volume reduction - compared between two cohorts (time frame: 12 months from recruitment). 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 18 Jan 2023.