Lymphedema After Gyneco-oncologic Treatment

NCT05469945 | Recruiting DMC

• 1 other identifier: BC 09915
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Lymphedema; Genital Neoplasm

Keywords

Lymphedema of the lower limb; Gynaecologic cancer; Sexual well-being; Quality of Life; Cost-investment; Time-investment

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (32)

• Timing of development of LLL

  From diagnosis until 2 years after last oncologic treatment

• Risk factors for developing LLL - per age category the number of patients that develop lower limb lymph-edema as assessed with ISL criteria

  From diagnosis until 2 years after last oncologic treatment

• Risk factors for developing LLL - weight

  From diagnosis until 2 years after last oncologic treatment

• Risk factors for developing LLL - height

  From diagnosis until 2 years after last oncologic treatment

• 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)

  From diagnosis until 2 years after last oncologic treatment

Other Outcomes (4)

• Tolerance of and compliance to preventive compressive garments as assessed with the ICC compression questionnaire

  From transition to stage until 1 year after

• Impact of preventive compressive garments on evolution of leg volume

  From transition to stage until 1 year after

• Impact of preventive compressive garments on patient's time investment, including putting on and of compressive garments, washing compressive clothing, skin care...

  From transition to stage until 1 year after

Study Arms (2)

Control arm: no compressive garments

NO INTERVENTION

Patients detected with early stage LLL (0-1 ISL stadia) start with education and preventive measures.

Interventional arm: start of CC2 compressive garments

EXPERIMENTAL

Patients in the experimental arm and detected with early stage LLL (0-1 ISL stadia) start with CC2 compressive garments in addition to education and preventive measures.

Device: Compressive garments class II

Interventions

Compressive garments class II DEVICE

Daily wearing of compressive garments, especially during prolonged standing upright or strenuous activities.

Also known as: Flat knit Medi Cosy compression class II stockings and/or bermuda

Interventional arm: start of CC2 compressive garments

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• History of treatment for gynaecologic cancer
• Concurrent second primary tumor(s)
• Pregnancy or pregnancy planned within 2 years
• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• University Hospital, Louvain: collaborator
• Kom Op Tegen Kanker: collaborator

Study Sites (2)

Ghent University Hospital, Dept. Radiotherapy-Oncology

Ghent, 9000, Belgium

RECRUITING

University Hospital, Louvain

Leuven, 3000, Belgium

RECRUITING

Related Publications (18)

• 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.

  PMID: 23288911 BACKGROUND

• 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.

  PMID: 25723779 BACKGROUND

• 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.

  PMID: 27566023 BACKGROUND

• 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.

  PMID: 28739682 BACKGROUND

• 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.

  PMID: 31837831 BACKGROUND

• 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.

  PMID: 31329510 BACKGROUND

• 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.

  PMID: 30121786 BACKGROUND

• 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.

  PMID: 21671698 BACKGROUND

• 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.

  PMID: 29908550 BACKGROUND

• 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.

  PMID: 33599683 BACKGROUND

• 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.

  PMID: 28242470 BACKGROUND

• 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.

  PMID: 18519968 BACKGROUND

• 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.

  PMID: 24415775 BACKGROUND

• 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.

  PMID: 24631452 BACKGROUND

• 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.

  PMID: 19955953 BACKGROUND

• 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.

  PMID: 24645535 BACKGROUND

• 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.

  PMID: 20215978 BACKGROUND

• Decorte T, Van Besien V, Van Calster C, Vanden Bossche L, Randon C, Devoogdt N, Monten C. Addition of prophylactic compression garments to standard care to prevent irreversible lower limb lymphoedema after gynaeco-oncological therapy (Gynolymph): protocol for a randomised controlled trial embedded within an observation cohort study. BMJ Open. 2024 Nov 1;14(10):e088851. doi: 10.1136/bmjopen-2024-088851.

  PMID: 39486824 DERIVED

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Chris Monten, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chris Monten, MD, PhD

CONTACT

093320749; chris.monten@uzgent.be

Caren Randon, MD, PhD

CONTACT

093326252; caren.randon@uzgent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking possible: the patient and the provider are well aware of yes or no wearing of compressive garments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial evaluating the added value of CC2 compressive garments in stage 0-1 LLL

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: July 22, 2022
• Study Start: June 22, 2022
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)