LymphedemacsplwgmNCT06873984
Compression Stockings for Lymphedema Prevention in Gynecologic Cancer Patients
A study testing compression products in people with Lymphedema, run by Joanna Kurpiewska-Pieniążek at 2 sites in Poland.
Trial summary
The goal of this clinical trial was to evaluate whether compression stockings (23-32 mmHg) reduce the incidence of postoperative lymphedema and accompanying symptoms, as well as to assess the comfort of using compression in women undergoing treatment for gynecological malignancies up to one year after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lymphedema
- What is being tested?
- compression products
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesPoland
- Study dates
- 1 Dec 2016to 20 Dec 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women who underwent radical surgery for vulvar cancer. Women who underwent radical surgery for cervical, uterine, or ovarian cancer, with systemic pelvic lymph node dissection.
- Overweight or obese patients (BMI > 25.0 kg/m²) treated for uterine or ovarian cancer, regardless of whether systemic pelvic lymph node dissection was performed.
- Women over 18 years of age.
Who cannot join
- Women with a history of lymphedema, venous edema, an ECOG score > 2, congestive heart failure, renal failure, hypothyroidism, leg ulcers, or severe lower limb ischemia (Fontaine class ≥ 2), as well as those with metastases, relapse, or other malignancies treated within five years prior to study entry, were excluded.
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Clinical Department of Gynecology and Gynecologic Oncology, University Hospital in Krakow".
Krakow, Lesser Poland Voivodeship, 31-501
Department of Gynecology and Obstetrics, including Gynecologic Oncology
Krakow, Lesser Poland Voivodeship, 31-826
About this study
Official title: Compression Stockings for Preventing Lower Limb Lymphedema in Women Treated for Gynecological Malignancies
The goal of this clinical trial was to evaluate whether compression stockings (23-32 mmHg) reduce the incidence of postoperative lymphedema and accompanying symptoms, as well as to assess the comfort of using compression in women undergoing treatment for gynecological malignancies up to one year after surgery.
The main objectives were to determine:
Read more
Whether compression stockings applied immediately after radical surgery, in combination with physical activity, reduce the risk of developing lymphedema.
Whether the use of compression stockings affects the quality of life. Whether compression stockings influence specific physical complaints related to the lower limbs.
Patients were assessed preoperatively and at 3, 6, and 12 months postoperatively. Limb circumferences were measured at predefined anatomical points to calculate limb volume changes over time. Additionally, subjective symptoms, quality of life, and adherence to compression therapy were evaluated.
Researchers compared a group using compression stockings with a control group without compression to analyze potential benefits and complications.
Read the detailed description
Background and Rationale Lymphedema is a frequent and debilitating complication following radical surgery for gynecological malignancies. It affects patients' quality of life, contributing to discomfort, impaired mobility, and an increased risk of infections. Despite the widespread use of compression therapy in managing lymphedema, there is limited evidence on its preventive role when applied immediately after surgery.
This study investigates the effectiveness of compression stockings (23-32 mmHg) in reducing the incidence of postoperative lower limb lymphedema and associated symptoms in women undergoing treatment for gynecological cancers. Additionally, it evaluates the impact of compression on patients' quality of life and physical complaints up to one year postoperatively.
A total of 75 eligible women consented to participate and were preoperatively randomized (simple randomization using a random number generator) into two groups:
Compression Group (CG): Patients received individually fitted round-knit compression stockings (23-32 mmHg, RAL-GZG standard) and were instructed to wear them for approximately 9 hours per day.
No Compression Group (NCG): Patients did not receive compression therapy.
Descriptive statistics were used to summarize the collected data, including mean (x̄), standard deviation (SD), median (Me), and percentage distributions.
For sociodemographic and clinical data, comparisons between groups were performed using the chi-square test for categorical variables and the independent t-test for continuous variables.
The effects of physiotherapeutic interventions were analyzed to determine statistically significant differences between groups. To assess the normality of data distribution, the Shapiro-Wilk test was applied.
For quantitative variables related to limb volume and WAC (Water-Assisted Circumference), comparisons between two groups were conducted using the Mann-Whitney U test. Comparisons of quantitative variables across three or more groups were performed using the Kruskal-Wallis test, followed by Dunn's post-hoc test when significant differences were detected.
Correlations between quantitative variables (e.g., limb volume and WAC) were assessed using Spearman's correlation coefficient.
For repeated measurements of quantitative variables (e.g., limb volume and WAC at multiple time points), comparisons were conducted using the Friedman test, and when significant differences were found, Wilcoxon signed-rank tests with Bonferroni correction were used for post-hoc analysis.
Qualitative variables were analyzed by calculating the number and percentage of occurrences for each category. Comparisons of categorical variables between groups were performed using the chi-square test (with Yates' correction for 2x2 tables) or Fisher's exact test for small expected frequencies.
For comparisons of continuous variables across two time points, the Wilcoxon signed-rank test for paired samples was used.
A significance level of p < 0.05 was adopted, and all p-values below this threshold were considered statistically significant.
- Conditions
- Lymphedema
- Being tested
- compression products
- Keywords
- Lower limb lympodema, compression therapy, quality of life
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
compression productsOther
Compression Group (CG):
Participants received individually fitted, round-knit compression stockings with a pressure of 23-32 mmHg (Class 2, RAL-GZG standard).
Compression garments were selected based on circumference measurements taken in the morning to ensure proper fit.
Participants were instructed to wear the stockings for approximately 9 hours per day.
The compression garments were provided by the same manufacturer (Medi GmbH \& Co., Bayreuth, Germany).
Additionally, participants were advised to engage in daily physical activity (walking for at least 20 minutes per day) while wearing compression.
Comprehensive education was provided on skin care, self-manual lymph drainage (simple lymph drainage, SLD), and lymphedema prevention.
| Study group | Role | What they receive |
|---|---|---|
| Compression Group (CG) | Experimental | Experimental: Compression Group (CG) Women in the CG group were provided with individually fitted round-knit compression stockings with a pressure of 23-32 mmHg (class 2, RAL-GZG standard classification). They received detailed instructions on usage, recommending approximately 9 hours of wear per day. The compression garments were selected based on circumference measurements taken in the morning and were sourced from the same manufacturer (Medi GmbH \& Co., Bayreuth, Germany).
In addition, physical activity (PA) was encouraged, specifically walking for 20 minutes daily, with compression stockings worn during the activity. All participants received comprehensive education on skin care, self-manual lymph drainage (simple lymph drainage, SLD), and lymphedema prevention. Proper skin hygiene was maintained through daily washing with hypoallergenic soap, thorough drying (especially between the toes and fingers), and regular skin moisturizing. A simplified version of manual lymph drainage wa Receives: Other: compression products |
| No Compression Group (NCG) | No intervention | Women in the NCG group did not receive compression therapy. However, they were encouraged to : Physical activity (PA) was recommended, specifically walking for 20 minutes every day. All women received comprehensive education on skin care, self-manual lymph drainage (simple lymph drainage, SLD), and lymphedema prevention. Proper skin hygiene was maintained through daily washing with hypoallergenic soap, thorough drying (especially between the fingers), and regular skin moisturizing. A simplified version of manual lymph drainage aimed at improving lymphatic flow was recommended for 20 minutes per day. The technique included the unaffected areas of the body (neck, chest, and abdomen). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lower Limb Volume (%)
Lower limb volume change (%) was calculated based on circumferential measurements taken every 4 cm along the limb, using the truncated cone formula. . The percentage change was calculated relative to preoperative limb volume.
Unit of Measure: Percentage (%)
Measured: Measurements were taken preoperatively and at 3, 6, and 12 months postoperatively
Secondary outcomes (3)
Presence of Lymphedema
Description: Lymphedema was diagnosed if limb volume increased by ≥10% compared to the contralateral limb or if skin stiffness appeared with a ≥8% volume difference.
Unit of Measure: Number of participants with lymphedema
Measured: were noted before and after 3, 6 and 12 months after surgery
Relative Edema Size (%)
If edema occurred, its relative size (%) was calculated as the volume difference between the affected and healthy limb, expressed as a percentage of the healthy limb's volume.
Unit of Measure: Percentage (%)
Measured: were taken before and after 3, 6 and 12 months after surgery i
Weight-Adjusted Volume Change (WAC) (%)
To account for body weight fluctuations, limb volume was normalized using the WAC formula:
WAC = (A2 * W1) / (W2 * A1) - 1 where A1 and A2 were pre- and postoperative limb volumes, and W1 and W2 were pre- and postoperative body weights.
Unit of Measure: Percentage (%)
Measured: were taken before and after 3, 6 and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start1 Dec 2016
- Primary completion29 Nov 2020
- Study completion20 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joanna Kurpiewska-Pieniążek
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joanna Kurpiewska-Pieniążek, Andrzej Frycz Modrzewski Krakow University
- Investigators
- Joanna Kurpiewska-Pieniążek, PhD, Principal investigator, Andrzej Frycz Modrzewski Krakow University, Krakow, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873984
- Sponsor's protocol ID
- Csplwgm-AFMKU
- Acronym
- csplwgm
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ochalek K, Gradalski T, Partsch H. Preventing Early Postoperative Arm Swelling and Lymphedema Manifestation by Compression Sleeves After Axillary Lymph Node Interventions in Breast Cancer Patients: A Randomized Controlled Trial. J Pain Symptom Manage. 2017 Sep;54(3):346-354. doi: 10.1016/j.jpainsymman.2017.04.014. Epub 2017 Aug 8.
PubMed 28797867Stuiver 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.
PubMed 24645535Sawan 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.
PubMed 19955953Hsu YY, Liu CY, Ho CL, Hsu KF. Determinants of quality of life related to lower limb lymphedema in women with gynecological cancer surgery. Asia Pac J Oncol Nurs. 2022 Oct 3;10(1):100153. doi: 10.1016/j.apjon.2022.100153. eCollection 2023 Jan.
PubMed 36406465Bowman C, Piedalue KA, Baydoun M, Carlson LE. The Quality of Life and Psychosocial Implications of Cancer-Related Lower-Extremity Lymphedema: A Systematic Review of the Literature. J Clin Med. 2020 Oct 2;9(10):3200. doi: 10.3390/jcm9103200.
PubMed 33023211Russo S, Walker JL, Carlson JW, Carter J, Ward LC, Covens A, Tanner EJ 3rd, Armer JM, Ridner S, Hayes S, Taghian AG, Brunelle C, Lopez-Acevedo M, Davidson BA, Schaverien MV, Ghamande SA, Bernas M, Cheville AL, Yost KJ, Schmitz K, Coyle B, Zucker J, Enserro D, Pugh S, Paskett ED, Ford L, McCaskill-Stevens W. Standardization of lower extremity quantitative lymphedema measurements and associated patient-reported outcomes in gynecologic cancers. Gynecol Oncol. 2021 Feb;160(2):625-632. doi: 10.1016/j.ygyno.2020.10.026. Epub 2020 Nov 4.
PubMed 33158510Huang J, Yu N, Wang X, Long X. Incidence of lower limb lymphedema after vulvar cancer: A systematic review and meta-analysis. Medicine (Baltimore). 2017 Nov;96(46):e8722. doi: 10.1097/MD.0000000000008722.
PubMed 29145314Yoshihara M, Shimono R, Tsuru S, Kitamura K, Sakuda H, Oguchi H, Hirota A. Risk factors for late-onset lower limb lymphedema after gynecological cancer treatment: A multi-institutional retrospective study. Eur J Surg Oncol. 2020 Jul;46(7):1334-1338. doi: 10.1016/j.ejso.2020.01.033. Epub 2020 Jan 31.
PubMed 32146054Wu X, Liu Y, Zhu D, Wang F, Ji J, Yan H. Early prevention of complex decongestive therapy and rehabilitation exercise for prevention of lower extremity lymphedema after operation of gynecologic cancer. Asian J Surg. 2021 Jan;44(1):111-115. doi: 10.1016/j.asjsur.2020.03.022. Epub 2020 May 10.
PubMed 32402630Hayes SC, Janda M, Ward LC, Reul-Hirche H, Steele ML, Carter J, Quinn M, Cornish B, Obermair A. Lymphedema following gynecological cancer: Results from a prospective, longitudinal cohort study on prevalence, incidence and risk factors. Gynecol Oncol. 2017 Sep;146(3):623-629. doi: 10.1016/j.ygyno.2017.06.004. Epub 2017 Jun 16.
PubMed 28624154
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compression Stockings for Preventing Lower Limb Lymphedema in Women Treated for Gynecological Malignancies
- ClinicalTrials.gov ID
- NCT06873984
- Acronym / sponsor ID
- csplwgm / Csplwgm-AFMKU
- Conditions
- Lymphedema
- Keywords
- Lower limb lympodema, compression therapy, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Joanna Kurpiewska-PieniążekUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 29 Nov 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 13 Mar 2025 (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.
The goal of this clinical trial was to evaluate whether compression stockings (23-32 mmHg) reduce the incidence of postoperative lymphedema and accompanying symptoms, as well as to assess the comfort of using compression in women undergoing treatment for gynecological malignancies up to one year after surgery.
The main objectives were to determine:
Whether compression stockings applied immediately after radical surgery, in combination with physical activity, reduce the risk of developing lymphedema.
Whether the use of compression stockings affects the quality of life. Whether compression stockings influence specific physical complaints related to the lower limbs.
Patients were assessed preoperatively and at 3, 6, and 12 months postoperatively. Limb circumferences were measured at predefined anatomical points to calculate limb volume changes over time. Additionally, subjective symptoms, quality of life, and adherence to compression therapy were evaluated.
Researchers compared a group using compression stockings with a control group without compression to analyze potential benefits and complications.
Detailed description
Background and Rationale Lymphedema is a frequent and debilitating complication following radical surgery for gynecological malignancies. It affects patients' quality of life, contributing to discomfort, impaired mobility, and an increased risk of infections. Despite the widespread use of compression therapy in managing lymphedema, there is limited evidence on its preventive role when applied immediately after surgery.
This study investigates the effectiveness of compression stockings (23-32 mmHg) in reducing the incidence of postoperative lower limb lymphedema and associated symptoms in women undergoing treatment for gynecological cancers. Additionally, it evaluates the impact of compression on patients' quality of life and physical complaints up to one year postoperatively.
A total of 75 eligible women consented to participate and were preoperatively randomized (simple randomization using a random number generator) into two groups:
Compression Group (CG): Patients received individually fitted round-knit compression stockings (23-32 mmHg, RAL-GZG standard) and were instructed to wear them for approximately 9 hours per day.
No Compression Group (NCG): Patients did not receive compression therapy.
Descriptive statistics were used to summarize the collected data, including mean (x̄), standard deviation (SD), median (Me), and percentage distributions.
For sociodemographic and clinical data, comparisons between groups were performed using the chi-square test for categorical variables and the independent t-test for continuous variables.
The effects of physiotherapeutic interventions were analyzed to determine statistically significant differences between groups. To assess the normality of data distribution, the Shapiro-Wilk test was applied.
For quantitative variables related to limb volume and WAC (Water-Assisted Circumference), comparisons between two groups were conducted using the Mann-Whitney U test. Comparisons of quantitative variables across three or more groups were performed using the Kruskal-Wallis test, followed by Dunn's post-hoc test when significant differences were detected.
Correlations between quantitative variables (e.g., limb volume and WAC) were assessed using Spearman's correlation coefficient.
For repeated measurements of quantitative variables (e.g., limb volume and WAC at multiple time points), comparisons were conducted using the Friedman test, and when significant differences were found, Wilcoxon signed-rank tests with Bonferroni correction were used for post-hoc analysis.
Qualitative variables were analyzed by calculating the number and percentage of occurrences for each category. Comparisons of categorical variables between groups were performed using the chi-square test (with Yates' correction for 2x2 tables) or Fisher's exact test for small expected frequencies.
For comparisons of continuous variables across two time points, the Wilcoxon signed-rank test for paired samples was used.
A significance level of p < 0.05 was adopted, and all p-values below this threshold were considered statistically significant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compression Group (CG) | Experimental | Other: compression productsExperimental: Compression Group (CG) Women in the CG group were provided with individually fitted round-knit compression stockings with a pressure of 23-32 mmHg (class 2, RAL-GZG standard classification). They received detailed instructions on usage, recommending approximately 9 hours of wear per day. The compression garments were selected based on circumference measurements taken in the morning and were sourced from the same manufacturer (Medi GmbH \& Co., Bayreuth, Germany). In addition, physical activity (PA) was encouraged, specifically walking for 20 minutes daily, with compression stockings worn during the activity. All participants received comprehensive education on skin care, self-manual lymph drainage (simple lymph drainage, SLD), and lymphedema prevention. Proper skin hygiene was maintained through daily washing with hypoallergenic soap, thorough drying (especially between the toes and fingers), and regular skin moisturizing. A simplified version of manual lymph drainage wa |
| No Compression Group (NCG) | No intervention | –Women in the NCG group did not receive compression therapy. However, they were encouraged to : Physical activity (PA) was recommended, specifically walking for 20 minutes every day. All women received comprehensive education on skin care, self-manual lymph drainage (simple lymph drainage, SLD), and lymphedema prevention. Proper skin hygiene was maintained through daily washing with hypoallergenic soap, thorough drying (especially between the fingers), and regular skin moisturizing. A simplified version of manual lymph drainage aimed at improving lymphatic flow was recommended for 20 minutes per day. The technique included the unaffected areas of the body (neck, chest, and abdomen). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women who underwent radical surgery for vulvar cancer. Women who underwent radical surgery for cervical, uterine, or ovarian cancer, with systemic pelvic lymph node dissection.
- Overweight or obese patients (BMI > 25.0 kg/m²) treated for uterine or ovarian cancer, regardless of whether systemic pelvic lymph node dissection was performed.
- Women over 18 years of age.
Key exclusion criteria (1 listed)
- Women with a history of lymphedema, venous edema, an ECOG score > 2, congestive heart failure, renal failure, hypothyroidism, leg ulcers, or severe lower limb ischemia (Fontaine class ≥ 2), as well as those with metastases, relapse, or other malignancies treated within five years prior to study entry, were excluded.
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 |
|---|---|---|
| compression productsCompression Group (CG): Participants received individually fitted, round-knit compression stockings with a pressure of 23-32 mmHg (Class 2, RAL-GZG standard). Compression garments were selected based on circumference measurements taken in the morning to ensure proper fit. Participants were instructed to wear the stockings for approximately 9 hours per day. The compression garments were provided by the same manufacturer (Medi GmbH \& Co., Bayreuth, Germany). Additionally, participants were advised to engage in daily physical activity (walking for at least 20 minutes per day) while wearing compression. Comprehensive education was provided on skin care, self-manual lymph drainage (simple lymph drainage, SLD), and lymphedema prevention. | Other | Compression Group (CG) |
Primary outcome
Change in Lower Limb Volume (%)
Time frame: Measurements were taken preoperatively and at 3, 6, and 12 months postoperatively
Lower limb volume change (%) was calculated based on circumferential measurements taken every 4 cm along the limb, using the truncated cone formula. . The percentage change was calculated relative to preoperative limb volume. Unit of Measure: Percentage (%)
3 secondary outcomes
Presence of Lymphedema
Time frame: were noted before and after 3, 6 and 12 months after surgery
Relative Edema Size (%)
Time frame: were taken before and after 3, 6 and 12 months after surgery i
Weight-Adjusted Volume Change (WAC) (%)
Time frame: were taken before and after 3, 6 and 12 months after surgery
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 13 Mar 2025.
- Background: PubMed 28797867Ochalek K, Gradalski T, Partsch H. Preventing Early Postoperative Arm Swelling and Lymphedema Manifestation by Compression Sleeves After Axillary Lymph Node Interventions in Breast Cancer Patients: A Randomized Controlled Trial. J Pain Symptom Manage. 2017 Sep;54(3):346-354. doi: 10.1016/j.jpainsymman.2017.04.014. Epub 2017 Aug 8.
- Background: PubMed 24645535Stuiver 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.
- Background: PubMed 19955953Sawan 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.
- Background: PubMed 36406465Hsu YY, Liu CY, Ho CL, Hsu KF. Determinants of quality of life related to lower limb lymphedema in women with gynecological cancer surgery. Asia Pac J Oncol Nurs. 2022 Oct 3;10(1):100153. doi: 10.1016/j.apjon.2022.100153. eCollection 2023 Jan.
- Background: PubMed 33023211Bowman C, Piedalue KA, Baydoun M, Carlson LE. The Quality of Life and Psychosocial Implications of Cancer-Related Lower-Extremity Lymphedema: A Systematic Review of the Literature. J Clin Med. 2020 Oct 2;9(10):3200. doi: 10.3390/jcm9103200.
- Background: PubMed 33158510Russo S, Walker JL, Carlson JW, Carter J, Ward LC, Covens A, Tanner EJ 3rd, Armer JM, Ridner S, Hayes S, Taghian AG, Brunelle C, Lopez-Acevedo M, Davidson BA, Schaverien MV, Ghamande SA, Bernas M, Cheville AL, Yost KJ, Schmitz K, Coyle B, Zucker J, Enserro D, Pugh S, Paskett ED, Ford L, McCaskill-Stevens W. Standardization of lower extremity quantitative lymphedema measurements and associated patient-reported outcomes in gynecologic cancers. Gynecol Oncol. 2021 Feb;160(2):625-632. doi: 10.1016/j.ygyno.2020.10.026. Epub 2020 Nov 4.
- Background: PubMed 29145314Huang J, Yu N, Wang X, Long X. Incidence of lower limb lymphedema after vulvar cancer: A systematic review and meta-analysis. Medicine (Baltimore). 2017 Nov;96(46):e8722. doi: 10.1097/MD.0000000000008722.
- Background: PubMed 32146054Yoshihara M, Shimono R, Tsuru S, Kitamura K, Sakuda H, Oguchi H, Hirota A. Risk factors for late-onset lower limb lymphedema after gynecological cancer treatment: A multi-institutional retrospective study. Eur J Surg Oncol. 2020 Jul;46(7):1334-1338. doi: 10.1016/j.ejso.2020.01.033. Epub 2020 Jan 31.
- Background: PubMed 32402630Wu X, Liu Y, Zhu D, Wang F, Ji J, Yan H. Early prevention of complex decongestive therapy and rehabilitation exercise for prevention of lower extremity lymphedema after operation of gynecologic cancer. Asian J Surg. 2021 Jan;44(1):111-115. doi: 10.1016/j.asjsur.2020.03.022. Epub 2020 May 10.
- Background: PubMed 28624154Hayes SC, Janda M, Ward LC, Reul-Hirche H, Steele ML, Carter J, Quinn M, Cornish B, Obermair A. Lymphedema following gynecological cancer: Results from a prospective, longitudinal cohort study on prevalence, incidence and risk factors. Gynecol Oncol. 2017 Sep;146(3):623-629. doi: 10.1016/j.ygyno.2017.06.004. Epub 2017 Jun 16.
- This page provides detailed information about the EORTC QLQ-C30 questionnaire, a standardized tool used to assess the quality of life in cancer patients.Link provided by the sponsor.
- Postoperative Effectiveness of Comprehensive Nursing Intervention for Lymphedema in Gynecological Cancer: A Controlled StudyLink provided by the sponsor.
- International Society of LymphologyLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Lymphedema
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
Enrolling by invitation
Comparison of the Effects of Kinesio Taping and Compression Bandaging on Edema, Range of Motion, Upper Extremity Function, and Grip Strength in Patients With Breast Cancer-Related Lymphedema
Lymphedema, Lymphedema Arm
RecruitingObservational study
A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
Open Surgery, Lymphedema
Not yet recruiting
Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors
Breast Neoplasm Malignant Primary, Lymphedema Arm
Active, not recruiting
The Effectiveness of Lymphatic Bypass Supermicrosurgery
Breast Cancer Related Lymphedema, Lymphedema Arm
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.
Joanna Kurpiewska-Pieniążek, PhD principal investigator
Andrzej Frycz Modrzewski Krakow University, Krakow, Poland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing compression products in people with Lymphedema, run by Joanna Kurpiewska-Pieniążek at 2 sites in Poland.
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 1 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 13 Mar 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 Poland. 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?
Change in Lower Limb Volume (%) (time frame: Measurements were taken preoperatively and at 3, 6, and 12 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06873984, which also lists 10 linked publications.
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 13 Mar 2025.