Lymphedema Clinical Trial
— GynolymphOfficial title:
Lower Limb Lymphedema After Gyneco-oncologic Therapy: Can we Prevent Irreversible Lymphedema?
NCT number | NCT05469945 |
Other study ID # | BC 09915 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 22, 2022 |
Est. completion date | June 30, 2028 |
Trial developed to inventory the incidence of early and advanced stage lower limb lymphedema in patients diagnosed with and treated for gynaecologic cancer. Four hundred patients with diagnosis stage 1-3 gynaecologic cancer will be included in an observational cohort between diagnosis until maximum 2 weeks after start of the first treatment. They will be followed for occurrence of lower limb lymphedema up till 2 years after their last treatment. Data on signs and symptoms, quality of life, time investment and financial expenses will be collected, to provide information on the incidence and risk factors for lower limb lymphedema, and on its impact on patients, regarding quality of life, sexual well-being and time- and financial investment. Patients developing early stage LLL enter an interventional sub-cohort, in which the effect of class II compressive garments on preventing evolution towards advanced stage LLL will be evaluated.
Status | Recruiting |
Enrollment | 218 |
Est. completion date | June 30, 2028 |
Est. primary completion date | June 30, 2027 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - Signed informed consent (ICF) - Female patient, recently diagnosed with gynaecologic cancer (cervix, endometrium, vulva, vagina, ovaries…) and candidate for curative treatment - Age = 18 years - Understanding of the Dutch language - Able to understand the informed consent and willing to comply with the protocol, including use of diary or app and timely completion of requested questionnaires. Exclusion Criteria: - History of treatment for gynaecologic cancer - Concurrent second primary tumor(s) - Pregnancy or pregnancy planned within 2 years - Known metastasized cancer at the time of inclusion (D0) - Severe injury, surgery or deformation of the legs or groins in the past - Vascular malformation of the leg or untreated venous insufficiency with oedema (CEAP C4 or more) - Mental or psychological problems, inability to comply to the study protocol - First treatment administered > 2 weeks before - Clinical signs and symptoms of lymphedema present (ISL stage 0 or higher) at the moment of intake |
Country | Name | City | State |
---|---|---|---|
Belgium | Ghent University Hospital, Dept. Radiotherapy-Oncology | Ghent | |
Belgium | University Hospital, Louvain | Louvain |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Ghent | Kom Op Tegen Kanker, University Hospital, Louvain |
Belgium,
Biglia N, Zanfagnin V, Daniele A, Robba E, Bounous VE. Lower Body Lymphedema in Patients with Gynecologic Cancer. Anticancer Res. 2017 Aug;37(8):4005-4015. doi: 10.21873/anticanres.11785. — View Citation
Carlson JW, Kauderer J, Hutson A, Carter J, Armer J, Lockwood S, Nolte S, Stewart BR, Wenzel L, Walker J, Fleury A, Bonebrake A, Soper J, Mathews C, Zivanovic O, Richards WE, Tan A, Alberts DS, Barakat RR. GOG 244-The lymphedema and gynecologic cancer (LEG) study: Incidence and risk factors in newly diagnosed patients. Gynecol Oncol. 2020 Feb;156(2):467-474. doi: 10.1016/j.ygyno.2019.10.009. Epub 2019 Dec 16. — View Citation
De Vrieze T, Gebruers N, Nevelsteen I, De Groef A, Tjalma WAA, Thomis S, Dams L, Van der Gucht E, Penen F, Devoogdt N. Reliability of the MoistureMeterD Compact Device and the Pitting Test to Evaluate Local Tissue Water in Subjects with Breast Cancer-Related Lymphedema. Lymphat Res Biol. 2020 Apr;18(2):116-128. doi: 10.1089/lrb.2019.0013. Epub 2019 Jul 19. — View Citation
Dean LT, Moss SL, Ransome Y, Frasso-Jaramillo L, Zhang Y, Visvanathan K, Nicholas LH, Schmitz KH. "It still affects our economic situation": long-term economic burden of breast cancer and lymphedema. Support Care Cancer. 2019 May;27(5):1697-1708. doi: 10.1007/s00520-018-4418-4. Epub 2018 Aug 18. — View Citation
Devoogdt N, De Groef A, Hendrickx A, Damstra R, Christiaansen A, Geraerts I, Vervloesem N, Vergote I, Van Kampen M. Lymphoedema Functioning, Disability and Health Questionnaire for Lower Limb Lymphoedema (Lymph-ICF-LL): reliability and validity. Phys Ther. 2014 May;94(5):705-21. doi: 10.2522/ptj.20130285. Epub 2014 Jan 10. — View Citation
Executive Committee. The Diagnosis and Treatment of Peripheral Lymphedema: 2016 Consensus Document of the International Society of Lymphology. Lymphology. 2016 Dec;49(4):170-84. — View Citation
Finnane A, Hayes SC, Obermair A, Janda M. Quality of life of women with lower-limb lymphedema following gynecological cancer. Expert Rev Pharmacoecon Outcomes Res. 2011 Jun;11(3):287-97. doi: 10.1586/erp.11.30. — View Citation
Hareyama H, Hada K, Goto K, Watanabe S, Hakoyama M, Oku K, Hayakashi Y, Hirayama E, Okuyama K. Prevalence, classification, and risk factors for postoperative lower extremity lymphedema in women with gynecologic malignancies: a retrospective study. Int J Gynecol Cancer. 2015 May;25(4):751-7. doi: 10.1097/IGC.0000000000000405. — View Citation
Lindqvist E, Wedin M, Fredrikson M, Kjolhede P. Lymphedema after treatment for endometrial cancer - A review of prevalence and risk factors. Eur J Obstet Gynecol Reprod Biol. 2017 Apr;211:112-121. doi: 10.1016/j.ejogrb.2017.02.021. Epub 2017 Feb 22. — View Citation
Mendivil AA, Rettenmaier MA, Abaid LN, Brown JV 3rd, Micha JP, Lopez KL, Goldstein BH. Lower-extremity lymphedema following management for endometrial and cervical cancer. Surg Oncol. 2016 Sep;25(3):200-4. doi: 10.1016/j.suronc.2016.05.015. Epub 2016 May 20. — View Citation
Roberson ML, Strassle PD, Fasehun LO, Erim DO, Deune EG, Ogunleye AA. Financial Burden of Lymphedema Hospitalizations in the United States. JAMA Oncol. 2021 Apr 1;7(4):630-632. doi: 10.1001/jamaoncol.2020.7891. — View Citation
Rockson SG, Rivera KK. Estimating the population burden of lymphedema. Ann N Y Acad Sci. 2008;1131:147-54. doi: 10.1196/annals.1413.014. — View Citation
Rowlands IJ, Beesley VL, Janda M, Hayes SC, Obermair A, Quinn MA, Brand A, Leung Y, McQuire L, Webb PM; Australian National Endometrial Cancer Study Group. Quality of life of women with lower limb swelling or lymphedema 3-5 years following endometrial cancer. Gynecol Oncol. 2014 May;133(2):314-8. doi: 10.1016/j.ygyno.2014.03.003. Epub 2014 Mar 11. — View Citation
Sawan S, Mugnai R, Lopes Ade B, Hughes A, Edmondson RJ. Lower-limb lymphedema and vulval cancer: feasibility of prophylactic compression garments and validation of leg volume measurement. Int J Gynecol Cancer. 2009 Dec;19(9):1649-54. doi: 10.1111/IGC.0b013e3181a8446a. — View Citation
Stuiver MM, de Rooij JD, Lucas C, Nieweg OE, Horenblas S, van Geel AN, van Beurden M, Aaronson NK. No evidence of benefit from class-II compression stockings in the prevention of lower-limb lymphedema after inguinal lymph node dissection: results of a randomized controlled trial. Lymphology. 2013 Sep;46(3):120-31. — View Citation
Tartaglione G, Pagan M, Morese R, Cappellini GA, Zappala AR, Sebastiani C, Paone G, Bernabucci V, Bartoletti R, Marchetti P, Marzola MC, Naji M, Rubello D. Intradermal lymphoscintigraphy at rest and after exercise: a new technique for the functional assessment of the lymphatic system in patients with lymphoedema. Nucl Med Commun. 2010 Jun;31(6):547-51. doi: 10.1097/MNM.0b013e328338277d. — View Citation
Yost KJ, Cheville AL, Weaver AL, Al Hilli M, Dowdy SC. Development and validation of a self-report lower-extremity lymphedema screening questionnaire in women. Phys Ther. 2013 May;93(5):694-703. doi: 10.2522/ptj.20120088. Epub 2013 Jan 3. — View Citation
* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Tolerance of and compliance to preventive compressive garments as assessed with the ICC compression questionnaire | Satisfaction with compressive garments assessed with ICC compression questionnaire, evaluation of functioning, symptoms of LLL, side-effects of compressive garments, feasibility of use, frequency and duration of wearing, autonomy, improvement or deterioration of functioning on social and job-level | From transition to stage until 1 year after | |
Other | Impact of preventive compressive garments on evolution of leg volume | Comparison of evolution of leg circumference measurement between the intervention group (compressive garments and the control group (no compressive garments), measuring leg circumference every 4cm, starting from a fixed point above the ankles to 17 measuring points above. Estimation of volume per leg is based on the truncated cone formula. | From transition to stage until 1 year after | |
Other | Impact of preventive compressive garments on patient's time investment, including putting on and of compressive garments, washing compressive clothing, skin care... | Inventory of mean time-investment of patients in the treatment of LLL through app-based registration, and comparison of time-investment between control group (no compressive garments) and interventional group (with compressive garments) | From transition to stage until 1 year after | |
Other | Impact of preventive compressive garments on financial investment, including reimbursed as well as out-of-pocket patient cost for compressive stockings, supplementary tools, nursing aid... | Inventory of mean financial investment of patients in the treatment of LLL through app-based registration, and comparison of time-investment between control group (no compressive garments) and interventional group (with compressive garments) | From transition to stage until 1 year after | |
Primary | Incidence rate of LLL | Number of patients with transition (evolution) to stage 0-3 LLL (ISL criteria) in the first two years after treatment for gynecologic cancer.
We defined three potential transitions: T1: from no LLL to reversible stage 0-1 LLL T2: from no LLL to irreversible stage 2-3 LLL T3: from stage 0-1 LLL to stage 2-3 LLL |
From diagnosis until 2 years after last oncologic treatment | |
Primary | Incidence rate of transition from stage 0-1 LLL to stage 2-3 LLL in randomized subgroup | Number of patients diagnosed with stage 0-1 LLL within one year after treatment for gynecologic cancer and that evolve from stage 0-1 LLL to stage 2-3 LLL | From transition to stage 0-1 LLL until 1 year after | |
Secondary | Timing of development of LLL | Registration of the timing of development of the different stages of LLL within the first two years after end of treatment | From diagnosis until 2 years after last oncologic treatment | |
Secondary | Risk factors for developing LLL - per age category the number of patients that develop lower limb lymph-edema as assessed with ISL criteria | Age: the amount of time something has been alive or has existed (years) | From diagnosis until 2 years after last oncologic treatment | |
Secondary | Risk factors for developing LLL - weight | Weight: In the operational definition, the weight of an object is the force measured by the operation of weighing it, which is the force it exerts on its support, expressed in kilograms (kg) | From diagnosis until 2 years after last oncologic treatment | |
Secondary | Risk factors for developing LLL - height | Height: measure of vertical extent (how "tall" something or someone is) (expressed in meters) | From diagnosis until 2 years after last oncologic treatment | |
Secondary | Risk factors for developing LLL - per BMI category the number of patients that develop lower limb lymph-edema as assessed with ISL criteria (reported value) | Body mass index (BMI) is a value derived from the mass (weight) and height of a person. The BMI is defined as the body mass divided by the square of the body height, and is expressed in units of kg/m2, resulting from mass in kilograms and height in metres. | From diagnosis until 2 years after last oncologic treatment | |
Secondary | Risk factors for developing LLL - per category of physical activity the number of patients that develop lower limb lymph-edema as assessed with ISL criteria | Physical activity is defined as any voluntary bodily movement produced by skeletal muscles that requires energy expenditure. Physical activity encompasses all activities, at any intensity, performed during any time of day or night. It includes both exercise and incidental activity integrated into daily routine. This integrated activity may not be planned, structured, repetitive or purposeful for the improvement of fitness, and may include activities such as walking to the local shop, cleaning, working, active transport etc.
Expressed in intensity level (categorical) |
From diagnosis until 2 years after last oncologic treatment | |
Secondary | Risk factors for developing LLL - Marital status | Civil status, or marital status, are the distinct options that describe a person's relationship with a significant other. Married, single, divorced, and widowed are examples of civil status.
Expressed in definition (categorical - married, divorced, widowed, single...) |
From diagnosis until 2 years after last oncologic treatment | |
Secondary | Risk factors for developing LLL - obstetrical status | Obstetrical history: medical specialty dealing with the care of all women's reproductive tracts and their children during pregnancy (prenatal period), childbirth and the postnatal period Obstetric state: gravida - partus - abortus - mater | From diagnosis until 2 years after last oncologic treatment | |
Secondary | Risk factors for developing LLL - education status | The International Standard Classification of Education (ISCED 2011) is a statistical framework for organizing information on education maintained by the United Nations Educational, Scientific and Cultural Organization (UNESCO). It is a member of the international family of economic and social classifications of the United Nations.
Categorical: lower secondary education, upper secondary education, Bachelor's or equivalent, Master's or equivalent, Doctorate or equivalent... |
From diagnosis until 2 years after last oncologic treatment | |
Secondary | Risk factors for developing LLL - employment status | Work or labor (or labour in British English) is intentional activity people perform to support themselves, others, or the needs and wants of a wider community Categorical: unemployed, employee, self-employed, retired, student, work-incapacity... | From diagnosis until 2 years after last oncologic treatment | |
Secondary | Risk factors for developing LLL - smoking status | Smoking is a practice in which a substance is burned and the resulting smoke is typically breathed in to be tasted and absorbed into the bloodstream.
Expressed in categories (never, used to smoke, active smoker) |
From diagnosis until 2 years after last oncologic treatment | |
Secondary | Risk factors for developing LLL - pack-years | Smoking is a practice in which a substance is burned and the resulting smoke is typically breathed in to be tasted and absorbed into the bloodstream.
A pack-year is a clinical quantification of cigarette smoking used to measure a person's exposure to tobacco. This is used to assess their risk of developing lung cancer or other pathologies related to tobacco use. Calculation: Number of pack-years = (number of cigarettes smoked per day/20) × number of years smoked. (1 pack has 20 cigarettes in some countries) |
From diagnosis until 2 years after last oncologic treatment | |
Secondary | Risk factors for developing LLL - alcohol intake | An alcoholic drink (also called an alcoholic beverage, adult beverage, or simply a drink) is a drink that contains ethanol, a type of alcohol produced by fermentation of grains, fruits, or other sources of sugar that acts as a drug.
Expressed in categories: never, occasionally, daily |
From diagnosis until 2 years after last oncologic treatment | |
Secondary | Risk factors for developing LLL - physical appearance | Human physical appearance is the outward phenotype or look of human beings. Registered as importance adhered to physical appearance on a rating scale from 1 to 10.
Expressed on a scale of one to ten, (this scale is a general and largely vernacular concept used for rating things, people, places, ideas, and so on. The scale has 10 as a maximum score, as a denotation of exceptionally high quality or of another attribute, a minimum of 0.) |
From diagnosis until 2 years after last oncologic treatment | |
Secondary | Risk factors for developing LLL - household income category | Household income is an economic standard that can be applied to one household, or aggregated across a large group such as a county, city, or the whole country. It is commonly used by government and private institutions to describe a household's economic status or to track economic trends.
Expressed in categories (per month): <1500, 1500-3000, >3000-5000, >5000 or 'does not wish to respond' |
From diagnosis until 2 years after last oncologic treatment | |
Secondary | Risk factors for developing LLL - number of patients with contact allergy that develop lower limb lymph-edema as assessed with ISL criteria | Allergies, also known as allergic diseases, are a number of conditions caused by hypersensitivity of the immune system to typically harmless substances in the environment. | From diagnosis until 2 years after last oncologic treatment | |
Secondary | Risk factors for developing LLL - number of patients with medical record of disease (renal, cardiac, diabetic...) that develop lower limb lymph-edema as assessed with ISL criteria | The medical history, case history, or anamnesis of a patient is information gained by a physician by asking specific questions, with the aim of obtaining information useful in formulating a diagnosis and providing medical care to the patient.
Expressed in relevant categories (cardiac, renal, vascular, cancer, auto-immune...) |
From diagnosis until 2 years after last oncologic treatment | |
Secondary | Risk factors for developing LLL - pain score | A pain scale measures a patient's pain intensity or other features. Pain scales are a common communication tool in medical contexts, and are used in a variety of medical settings.
Expressed on a scale of one to ten, (this scale is a general and largely vernacular concept used for rating things, people, places, ideas, and so on. The scale has 10 as a denotation of exceptionally high pain, and a minimum of 0 for no pain at all.) |
From diagnosis until 2 years after last oncologic treatment | |
Secondary | Risk factors for developing LLL - tumor stage (TNM) | The TNM Classification of Malignant Tumors (TNM) is a globally recognised standard for classifying the extent of spread of cancer. It is a classification system of the anatomical extent of tumor cancers.
Most common tumors have their own TNM classification. Sometimes also described as the AJCC system. TNM is a notation system that describes the stage of a cancer, which originates from a solid tumor, using alphanumeric codes: T describes the size of the original (primary) tumor and whether it has invaded nearby tissue, N describes nearby (regional) lymph nodes that are involved, M describes distant metastasis (spread of cancer from one part of the body to another). |
From diagnosis until 2 years after last oncologic treatment | |
Secondary | Risk factors for developing LLL - tumor stage (FIGO) | The International Federation of Gynaecology and Obstetrics, usually just FIGO as the acronym of its French name Fédération Internationale de Gynécologie et d'Obstétrique, is a worldwide non-governmental organisation representing obstetricians and gynaecologists in over one hundred territories.
The FIGO staging system is used most often for cancers of the female reproductive organs, including cervical cancer, endometrial cancer, ovarian cancer... As a rule, the lower the number, the less the cancer has spread. A higher number, such as stage IV, means a more advanced cancer. And within a stage, an earlier letter means a lower stage. Cancers with similar stages tend to have a similar outlook and are often treated in much the same way. |
From diagnosis until 2 years after last oncologic treatment | |
Secondary | Risk factors for developing LLL - the number of patients with limited (only one or two gynaecologic organs) or extensive surgery (multiple organs and/or lymph nodes) that develop lower limb lymph-edema as assessed with ISL criteria | Gynecological surgery refers to surgery on the female reproductive system usually performed by gynecologists. In the domain of cancer it may include hysterectomy, ovariectomy, pelvic exenteration, salpingoophorectomy, vulvectomy and partial or complete lymphadenectomy | From diagnosis until 2 years after last oncologic treatment | |
Secondary | Risk factors for developing LLL - the number of patients receiving systemic therapy that develop lower limb lymph-edema as assessed with ISL criteria | Systemic therapy is a therapy that is given in addition to the primary or initial therapy to maximize its effectiveness. It can be given in adjuvant or neo-adjuvant setting.
Categorical: none, taxanes, cisplatinum, immunotherapy, target therapy, anti-hormone therapy, other. |
From diagnosis until 2 years after last oncologic treatment | |
Secondary | Risk factors for developing LLL - the number of patients receiving radiotherapy that develop lower limb lymph-edema as assessed with ISL criteria | Radiation therapy or radiotherapy, often abbreviated RT, RTx, or XRT, is a therapy using ionizing radiation, generally provided as part of cancer treatment to control or kill malignant cells and normally delivered by a linear accelerator. Radiation therapy may be curative in a number of types of cancer if they are localized to one area of the body. It may also be used as part of adjuvant therapy, to prevent tumor recurrence after surgery to remove a primary malignant tumor (for example, early stages of breast cancer). Radiation therapy is synergistic with chemotherapy, and has been used before, during, and after chemotherapy in susceptible cancers.
Expressed per target volume in dose per fraction, number of fractions |
From diagnosis until 2 years after last oncologic treatment | |
Secondary | Impact of LLL on QoL - EQ5D | EQ-5D is a standardised measure of health-related quality of life developed by the EuroQol Group to provide a simple, generic questionnaire for use in clinical and economic appraisal and population health surveys. EQ-5D assesses health status in terms of five dimensions of health and is considered a 'generic' questionnaire because these dimensions are not specific to any one patient group or health condition. EQ-5D can also be referred to as a patient-reported outcome (PRO) measure, because patients can complete the questionnaire themselves to provide information about their current health status and how this changes over time. 'EQ-5D' is not an abbreviation and is the correct term to use when referring to the instrument in general.
Expressed as an overall measure of self-assessed health status (EQ VAS) at different time points (D0, M3, M12) |
From diagnosis until 2 years after last oncologic treatment | |
Secondary | Impact of LLL on QoL - EORT qlq C30 | European Organisation for Research and Treatment of Cancer (EORTC): qlq C30: questionnaire developed by the EORTC and validated in over 100 languages, in order to assess in 30 questions the quality of life of cancer patients. | From diagnosis until 2 years after last oncologic treatment | |
Secondary | Impact of LLL on QoL - lymph-ICF-LL | Lymphoedema Functioning, Disability and Health Questionnaire for Lower Limb Lymphoedema (Lymph-ICF-LL): it is a descriptive, evaluative tool containing 28 questions about impairments in function, activity limitations, and participation restrictions in patients with lower limb lymphedema. The questionnaire has 5 domains: physical function, mental function, general tasks/household activities, mobility activities, and life domains/social life. | From diagnosis until 2 years after last oncologic treatment | |
Secondary | Impact of LLL on sexuality | Female Sexual Distress Scale Revised (FSDS-R) is a multi-dimensional self-reporting questionnaire containing 13 items to evaluate sexual distress in women.
Evaluation: Percentage of patients with clinically relevant loss in sexual well-being, measured through questionnaire at baseline, 3 months, 12 months and 24 months post-treatment |
From diagnosis until 2 years after last oncologic treatment | |
Secondary | Predictive value of the self-report LLL questionnaire | The self-report lower-extremity lymphedema screening questionnaire is a screening questionnaire developed to detect lower-extremity lymphedema (LEL) among normal-weight women and women with obesity.
Evaluation: Number of patients with score >5 on the self-report LLL questionnaire that are diagnosed with LLL according to ISL criteria (positive predictive value) |
From diagnosis until 2 years after last oncologic treatment | |
Secondary | Value of ICG fluoroscopy versus lymphoscintigraphy in detection of early stage LLL | Percentage of positive ICG fluoroscopy (image of splash, stardust or diffuse ICG pattern) corresponding with positive lympho-scintigraphy (signs of impaired lymphatic flow) or with clinical diagnosis of LLL based on ISL criteria | From diagnosis until 2 years after last oncologic treatment | |
Secondary | Inventory of time investment | Calculation of mean time investment of patients in the prevention and treatment of LLL through app-based registration | From diagnosis until 2 years after last oncologic treatment | |
Secondary | Inventory of expenses | Calculation of mean financial investment of patients in the prevention and treatment of LLL through app-based registration | From diagnosis until 2 years after last oncologic treatment | |
Secondary | Standardization of perimetric measurements | Development of standardized instructions for perimetric measurement with measurement from a fixed start point and then every 4cm to calculate leg circumference. Verification of reliability through intra- and interobserver comparison | From diagnosis until 2 years after last oncologic treatment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05507346 -
A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema
|
N/A | |
Completed |
NCT06067880 -
Surgical Intervention and Lymphatic Diseases.
|
||
Active, not recruiting |
NCT04797390 -
A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema
|
N/A | |
Completed |
NCT02676752 -
Skin/Soft Tissue Elasticity in Head and Neck Cancer Survivors With Lymphedema and Fibrosis
|
||
Completed |
NCT06323200 -
Lymphedema Duration on Lymphatic Vessel Quality and Outcomes After LVA
|
||
Completed |
NCT02506530 -
Treatment Pathway of Patients Suffering From a Breast Cancer Related Lymphoedema
|
N/A | |
Completed |
NCT02253186 -
Clinical Study to Assess Safety and Efficacy of a New Armsleeve in the Management of Arm Lymphoedema
|
N/A | |
Terminated |
NCT02020837 -
A Pilot Study Assessing the Effect of Lymphaticovenous Micro-Anastomosis in the Treatment of Postmastectomy Lymphedema
|
Early Phase 1 | |
Recruiting |
NCT01318785 -
Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications
|
Phase 2 | |
Enrolling by invitation |
NCT02375165 -
Biomarkers for the Detection of Lymphatic Insufficiency
|
||
Completed |
NCT02308488 -
Study of Prone Accelerated Breast And Nodal IMRT
|
N/A | |
Completed |
NCT01112189 -
Use of Stem Cells in Lymphedema Post Mastectomy
|
Phase 1/Phase 2 | |
Completed |
NCT00852930 -
Low Level Laser Treatment and Breast Cancer Related Lymphedema
|
Phase 4 | |
Completed |
NCT00743314 -
Single-Photon Emission Computed Tomography, Computed Tomography Lymphoscintigraphy, and Intensity-Modulated Radiation Therapy in Treating Patients Who Have Undergone Surgery for Stage I or Stage II Breast Cancer
|
Early Phase 1 | |
Recruiting |
NCT06237907 -
Pyroptosis and Ferroptosis in the Pathophysiology of Lymphedema
|
||
Terminated |
NCT01580800 -
National Breast Cancer and Lymphedema Registry
|
||
Suspended |
NCT05366699 -
LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy
|
N/A | |
Completed |
NCT06249360 -
Lymphatic System Reflux After Lymphatic Operation
|
||
Completed |
NCT06220903 -
The Effect of Complex Decongestive Therapy in Patients With Lymphedema
|
N/A | |
Terminated |
NCT02923037 -
Hatha Yoga in Breast Cancer Survivors
|
N/A |