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PRELUDE Study of Lymphatic Surgery to Treat Breast Cancer Related Lymphoedema (PRELUDE)

Primary Purpose

Breast Cancer, Lymphedema

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Lymphaticovenous anastomosis surgery combined with near infrared spectroscopy imaging
Sponsored by
Royal Marsden NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • • 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

Sites / Locations

  • Mark Brandon-GroveRecruiting
  • Mark Brandon-GroveRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Surgical Cohort

Non-surgical cohort

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Bio-impedance spectroscopy
Compare changes in bio-impedance spectroscopy during the period of the study
Cellulitis
Compare the incidence of cellulitis in both groups within the 12-month study period
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)
Compliance
Compliance with use of compression therapy during the study.

Full Information

First Posted
October 1, 2020
Last Updated
January 17, 2023
Sponsor
Royal Marsden NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04579029
Brief Title
PRELUDE Study of Lymphatic Surgery to Treat Breast Cancer Related Lymphoedema
Acronym
PRELUDE
Official Title
Prospective Randomized Evaluation of Lymphaticovenous Anastomosis Using Dynamic Imaging in Breast Cancer-related Lymphoedema
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 13, 2021 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Marsden NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Lymphedema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgical Cohort
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-surgical cohort
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Lymphaticovenous anastomosis surgery combined with near infrared spectroscopy imaging
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean excess volume reduction - compared between two cohorts
Description
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.
Time Frame
12 months from recruitment
Secondary Outcome Measure Information:
Title
Safety - infection and surgical complications
Description
Assess the safety of LVA surgery (supported by PDE imaging guidance) by recording incidence of infection and post-operative complications.
Time Frame
12 months from recruitment
Title
Bio-impedance spectroscopy
Description
Compare changes in bio-impedance spectroscopy during the period of the study
Time Frame
12 months from recruitment
Title
Cellulitis
Description
Compare the incidence of cellulitis in both groups within the 12-month study period
Time Frame
12 months from recruitment
Title
Quality of life - LYMQOL score
Description
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)
Time Frame
12 months from recruitment
Title
Compliance
Description
Compliance with use of compression therapy during the study.
Time Frame
12 months from recruitment

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
All participants will be having treatment for female breast cancer
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: • 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelvin WD Ramsey, FRCS(Plast)
Phone
02078082208
Email
Kelvin.Ramsey@rmh.nhs.uk
Facility Information:
Facility Name
Mark Brandon-Grove
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Brandon-Grove
Phone
02031865416
Email
Mark.Brandon-Grove@rmh.nhs.uk
Facility Name
Mark Brandon-Grove
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Brandon-Grove
Phone
02031865416
Email
Mark.Brandon-Grove@rmh.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

PRELUDE Study of Lymphatic Surgery to Treat Breast Cancer Related Lymphoedema

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