Carcinoma of the EndometriumLASECNCT02115477

Lymphedema After Primary Surgery for Endometrial Cancer

An observational study of Carcinoma of the Endometrium and Hysterectomy, run by Preben Kjolhede, MD, professor at 16 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purposes of this study are to determine the prevalence, size and impact on quality of life of lymphedema of the lower extremities after primary radical surgery with hysterectomy +/- pelvic - and paraaortic lymphadenectomy in women with endometrial uterine carcinoma FIGO (International Federation of Gynecology and… Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Carcinoma of the Endometrium, Hysterectomy, Lymphadenectomy
What is being tested?: Lymphadenectomy
Type of treatment: Surgery or procedure
How many people: 262 participants
Where: 16 sitesSweden
Study dates: 17 Apr 2014to 17 Dec 2018
Phase: Observational
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

Study population: All women admitted to the participating clinics for primary surgery of endometrial carcinoma FIGO stage 1 and 2 will be asked to participate in the study.

Who may be able to join

Age >=18 years.
Women with endometrial carcinoma preoperatively evaluated to be uterine cancer FIGO stage1 or 2 who are planned for primary radical surgery including simple or radical hysterectomy, bilateral salpingoophorectomy,+/- pelvic and paraaortic lymphadenectomy and +/- omentectomy with curative intention.
WHO performance status ≤ 2.
Understand and speak Swedish fluently
Accept to participate in the study by giving verbal and written informed consent.

Who cannot join

Sarcoma of the uterus
Previous pelvic or paraaortic lymphadenectomy.
Previous having had pelvic radiation therapy.
Ongoing treatment of arterial or venous insufficiency of the lower limbs
Congenital or acquired malformations in the lymphatic system.
Ongoing or previous treatment of lymphedema of the upper or lower limbs.

Show all 9Show fewer

Physically disability which impair mobilisation immediately postoperatively.
Severe psychiatric disease and untreated mild/moderate psychiatric disease.
Mentally retarded to a degree so she does not understand the meaning of the participation or cannot fill in the questionnaires.or the physician finds it ethically doubtful to enroll the patient in the study

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

Sweden16 sites

Highland hospital
Eksjö, Jonkopings Län, 57533
Falu Central Hospital
Falun, 79182
Gävle County Hospital
Gävle, 80187
Sahlgrenska University Hospital
Gothenburg, 41345
Region Halland Halmstad Hospital
Halmstad, 30233
County Hospital in Kalmar
Kalmar, 39185
Blekinge Hospital
Karlskrona, 37185
Karlstad Central Hospital
Karlstad, 65185
Linkoping University Hospital
Linköping, 58185
Södra Älvborgs Sjukhus
Skövde, +4651085000
Sundsvall Hospital
Sundsvall, 85186
Norra Älvborgs Hospital
Trollhättan, 46185
Norrlands University Hospital
Umeå, 90185
Akademiska University Hospital
Uppsala, 75185
Region Halland Varberg hospital
Varberg, 43281
Västervik County Hospital
Västervik, 59381

Other trials in Sweden

About this study

Official title: Prevalence, Complications and Risk Factors for Lymphedema After Pelvic and Paraaortic Lymphadenectomy in Primary Radical Surgery for Early Stage Endometrial Carcinoma.

The purposes of this study are

to determine the prevalence, size and impact on quality of life of lymphedema of the lower extremities after primary radical surgery with hysterectomy +/- pelvic - and paraaortic lymphadenectomy in women with endometrial uterine carcinoma FIGO (International Federation of Gynecology and Obstetrics) stage 1 and 2
to analyze risk factors for development of lymphedema in this specific group of patients.

Our hypotheses are that women who have lymphadenectomy more often suffer from lymphedema, subjectively and objectively, and have an impaired quality of life.

This is a Swedish multicenter study carried out in 17 departments of Obstetrics and Gynecology and in 3 departments of Oncology. All participants are treated according to the Swedish National Guidelines for Endometrial Cancer.

130 women with endometrial cancer who have a hysterectomy with lymphadenectomy (high-risk endometrial carcinomas) and 130 women with endometrial cancer who have a hysterectomy without lymphadenectomy (low-risk endometrial carcinomas) are prospectively enrolled in the study.

The participants are examined preoperatively and on 3 occasions postoperatively, i.e. 4-6 weeks , 6 months and 12 months postoperatively.

Determination of occurrence of lymphedema of the lower extremities are determined objectively by 1) a standardized clinical evaluation according to Bruna et al.[1] and 2) determining the leg volume according to the cone model by Sitzia [2] by systematically measuring of leg circumferences. In addition, occurrence of lymphedema is measured subjectively by the participants.

On the same four occasions as the leg circumference measurements are conducted the patients complete two generic health related quality of life forms (the EuroQol EQ-5D and the Short-Form 36 SF-36) and the condition specific quality of life form for limb lymphedema (LYMQOL).

Demographic and clinical data are systematically collected until one year postoperatively including occurrence of complications and given adjuvant oncological therapy such as chemo- and radiation therapy.

On each occasion of clinical control a vaginal ultrasound examination is carried out in order to register pelvic and abdominal lymphocele formation or lymphatic fluid effusion intraabdominally.

Read the detailed description

Not included

Conditions: Carcinoma of the Endometrium, Hysterectomy, Lymphadenectomy
Being tested: Lymphadenectomy
Keywords: Uterus cancer, Hysterectomy, Lymphadenectomy, Lymphedema
Medical subject headings: Endometrial Neoplasms, Uterine Neoplasms, Lymphedema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LymphadenectomyProcedure or surgery
Pelvic and/or paraaortic lymphadenectomy

Study groups in NCT02115477
Study group	Role	What they receive
Group with lymphadenectomy		The group of women with high risk endometrial cancer who undergoes pelvic and/or paraaortic lymphadenectomy at primary surgery Receives: Procedure: Lymphadenectomy
Group without lymphadenectomy		The group of women with low risk endometrial cancer who do not have lymphadenectomy at primary surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in leg volume from baseline (preoperatively) to 4-6 weeks postoperatively
Leg volume is determined by the cone model according to Sitzia by measuring leg circumferences systematically.
Measured: 4-6 weeks after the primary surgery
Change in leg volume from baseline (preoperatively) to 6 months postoperatively
Leg volume is determined by the cone model according to Sitzia by measuring leg circumferences systematically.
Measured: 6 months after the primary surgery
Change in leg volume from baseline (preoperatively) to 12 months postoperatively
Leg volume is determined by the cone model according to Sitzia by measuring leg circumferences systematically.
Measured: 12 months after the primary surgery

Secondary outcomes (5)

Change in quality of life assessment from baseline (preoperatively) to 4-6 weeks postoperatively
Quality of life measured by means of The EuroQol (EQ-5D), the Short-Form 36 (SF-36) and the condition specific quality of life form LYMQOL.
Measured: 4-6 weeks from the primary surgery
Change in quality of life assessment from baseline (preoperatively) to 6 months postoperatively
Quality of life measured by means of The EuroQol (EQ-5D), the Short-Form 36 (SF-36) and the condition specific quality of life form LYMQOL.
Measured: 6 months from the primary surgery
Change in quality of life assessment from baseline (preoperatively) to 12 months postoperatively
Quality of life measured by means of The EuroQol (EQ-5D), the Short-Form 36 (SF-36) and the condition specific quality of life form LYMQOL.
Measured: 12 months from the primary surgery
Percentage of participants with an increase in leg volume of > 15% 12 months postoperatively
Measured: 12 months after the primary surgery
Percentage of participants who states they have lymphedema
Occurrence of lymphedema subjectively graded as 2 or more on an ordinal scale from 1 to 4. 1 express no swelling of the legs and 4 express severe swelling.
Measured: 12 months from the primary surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Apr 201417 Dec 2018

First posted16 Apr 2014 (estimated)
Study start17 Apr 2014
Primary completion17 Dec 2018
Study completion17 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Carcinoma of the EndometriumStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 262 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02115477
Sponsor's protocol ID: Version 2013-09-22/2014-03-21
Other IDs: The Swedish Cancer Society
Acronym: LASEC
Status last verified: Oct 2019
First submitted: 13 Apr 2014
Last updated: 25 Oct 2019
Results posted: No
Data monitoring committee: No

Publications

Miller AJ, Bruna J, Beninson J. A universally applicable clinical classification of lymphedema. Angiology. 1999 Mar;50(3):189-92. doi: 10.1177/000331979905000302.
PubMed 10088797
Sitzia J. Volume measurement in lymphoedema treatment: examination of formulae. Eur J Cancer Care (Engl). 1995 Mar;4(1):11-6. doi: 10.1111/j.1365-2354.1995.tb00047.x.
PubMed 7620649

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Carcinoma of the Endometrium trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prevalence, Complications and Risk Factors for Lymphedema After Pelvic and Paraaortic Lymphadenectomy in Primary Radical Surgery for Early Stage Endometrial Carcinoma.
ClinicalTrials.gov ID: NCT02115477
Acronym / sponsor ID: LASEC / Version 2013-09-22/2014-03-21
Conditions: Carcinoma of the Endometrium, Hysterectomy, Lymphadenectomy
Keywords: Uterus cancer, Hysterectomy, Lymphadenectomy, Lymphedema
Study type: Observational
Recruitment status: Completed
Enrolment: 262 participants (actual)
Lead sponsor: Preben Kjolhede, MD, professorUniversity, hospital or other
Collaborators: Swedish Cancer Society, Medical Research Council of Southeast Sweden, Ostergotland County Council, Sweden, Linkoeping University
Study start: 17 Apr 2014 (actual)
Primary completion: 17 Dec 2018 (actual)
Study completion: 17 Dec 2018 (actual)
First posted: 16 Apr 2014 (estimated)
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 purposes of this study are

to determine the prevalence, size and impact on quality of life of lymphedema of the lower extremities after primary radical surgery with hysterectomy +/- pelvic - and paraaortic lymphadenectomy in women with endometrial uterine carcinoma FIGO (International Federation of Gynecology and Obstetrics) stage 1 and 2
to analyze risk factors for development of lymphedema in this specific group of patients.

Our hypotheses are that women who have lymphadenectomy more often suffer from lymphedema, subjectively and objectively, and have an impaired quality of life.

The participants are examined preoperatively and on 3 occasions postoperatively, i.e. 4-6 weeks , 6 months and 12 months postoperatively.

On each occasion of clinical control a vaginal ultrasound examination is carried out in order to register pelvic and abdominal lymphocele formation or lymphatic fluid effusion intraabdominally.

Detailed description

Not included

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Group with lymphadenectomy	–	Procedure: LymphadenectomyThe group of women with high risk endometrial cancer who undergoes pelvic and/or paraaortic lymphadenectomy at primary surgery
Group without lymphadenectomy	–	–The group of women with low risk endometrial cancer who do not have lymphadenectomy at primary surgery

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: All women admitted to the participating clinics for primary surgery of endometrial carcinoma FIGO stage 1 and 2 will be asked to participate in the study.

Key inclusion criteria (5 listed)

Age >=18 years.
Women with endometrial carcinoma preoperatively evaluated to be uterine cancer FIGO stage1 or 2 who are planned for primary radical surgery including simple or radical hysterectomy, bilateral salpingoophorectomy,+/- pelvic and paraaortic lymphadenectomy and +/- omentectomy with curative intention.
WHO performance status ≤ 2.
Understand and speak Swedish fluently
Accept to participate in the study by giving verbal and written informed consent.

Key exclusion criteria (9 listed)

Sarcoma of the uterus
Previous pelvic or paraaortic lymphadenectomy.
Previous having had pelvic radiation therapy.
Ongoing treatment of arterial or venous insufficiency of the lower limbs
Congenital or acquired malformations in the lymphatic system.

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
LymphadenectomyPelvic and/or paraaortic lymphadenectomy	Procedure or surgery	Group with lymphadenectomy

Primary outcome

Change in leg volume from baseline (preoperatively) to 4-6 weeks postoperatively
Time frame: 4-6 weeks after the primary surgery
Leg volume is determined by the cone model according to Sitzia by measuring leg circumferences systematically.
Change in leg volume from baseline (preoperatively) to 6 months postoperatively
Time frame: 6 months after the primary surgery
Leg volume is determined by the cone model according to Sitzia by measuring leg circumferences systematically.
Change in leg volume from baseline (preoperatively) to 12 months postoperatively
Time frame: 12 months after the primary surgery
Leg volume is determined by the cone model according to Sitzia by measuring leg circumferences systematically.

5 secondary outcomes

Change in quality of life assessment from baseline (preoperatively) to 4-6 weeks postoperatively
Time frame: 4-6 weeks from the primary surgery
Change in quality of life assessment from baseline (preoperatively) to 6 months postoperatively
Time frame: 6 months from the primary surgery
Change in quality of life assessment from baseline (preoperatively) to 12 months postoperatively
Time frame: 12 months from the primary surgery
Percentage of participants with an increase in leg volume of > 15% 12 months postoperatively
Time frame: 12 months after the primary surgery
Percentage of participants who states they have lymphedema
Time frame: 12 months from the primary 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 25 Oct 2019.
Background: PubMed 10088797Miller AJ, Bruna J, Beninson J. A universally applicable clinical classification of lymphedema. Angiology. 1999 Mar;50(3):189-92. doi: 10.1177/000331979905000302.
Background: PubMed 7620649Sitzia J. Volume measurement in lymphoedema treatment: examination of formulae. Eur J Cancer Care (Engl). 1995 Mar;4(1):11-6. doi: 10.1111/j.1365-2354.1995.tb00047.x.

Related trials for Carcinoma of the Endometrium

Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruitingPhase 3
Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line
Endometrial Cancer
RecruitingPhase 3
Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
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RecruitingPhase 3
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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.

Preben Kjölhede, MD, PhD study chair

Dept of Obs/Gyn, University Hospital, Linköping

Per Rosenberg, MD,PhD study chair

Dept of Oncology, University Hospital, Linköping

Gabriel Lindahl, MD study chair

Dept of Oncology, University Hospital, Linköping

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Carcinoma of the Endometrium and Hysterectomy, run by Preben Kjolhede, MD, professor at 16 sites in Sweden.

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 5 inclusion and 9 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 25 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Sweden. 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 leg volume from baseline (preoperatively) to 4-6 weeks postoperatively (time frame: 4-6 weeks after the primary surgery). The study lists 3 primary outcomes in all. 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 NCT02115477, which also lists 2 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 25 Oct 2019.