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Lymphedema After Primary Surgery for Endometrial Cancer (LASEC)

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ClinicalTrials.gov Identifier: NCT02115477
Recruitment Status : Unknown
Verified February 2016 by Preben Kjolhede, MD, professor, University Hospital, Linkoeping.
Recruitment status was:  Recruiting
First Posted : April 16, 2014
Last Update Posted : February 23, 2016
Sponsor:
Collaborators:
Swedish Cancer Society
Medical Research Council of Southeast Sweden
Ostergotland County Council, Sweden
Linkoeping University
Information provided by (Responsible Party):
Preben Kjolhede, MD, professor, University Hospital, Linkoeping

Brief 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 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.


Condition or disease Intervention/treatment
Carcinoma of the Endometrium Hysterectomy Lymphadenectomy Procedure: Lymphadenectomy

Detailed Description:
Not included

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Study Type : Observational
Estimated Enrollment : 260 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence, Complications and Risk Factors for Lymphedema After Pelvic and Paraaortic Lymphadenectomy in Primary Radical Surgery for Early Stage Endometrial Carcinoma.
Study Start Date : April 2014
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Group/Cohort Intervention/treatment
Group with lymphadenectomy
The group of women with high risk endometrial cancer who undergoes pelvic and/or paraaortic lymphadenectomy at primary surgery
Procedure: Lymphadenectomy
Pelvic and/or paraaortic lymphadenectomy

Group without lymphadenectomy
The group of women with low risk endometrial cancer who do not have lymphadenectomy at primary surgery



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Change in quality of life assessment from baseline (preoperatively) to 4-6 weeks postoperatively [ Time Frame: 4-6 weeks from the primary surgery ]
    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.

  2. Change in quality of life assessment from baseline (preoperatively) to 6 months postoperatively [ Time Frame: 6 months from the primary surgery ]
    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.

  3. Change in quality of life assessment from baseline (preoperatively) to 12 months postoperatively [ Time Frame: 12 months from the primary surgery ]
    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.

  4. Percentage of participants with an increase in leg volume of > 15% 12 months postoperatively [ Time Frame: 12 months after the primary surgery ]
  5. Percentage of participants who states they have lymphedema [ Time Frame: 12 months from the primary surgery ]
    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.


Other Outcome Measures:
  1. Risk factors for lymphedema after primary surgery with lymphadenectomy for endometrial cancer [ Time Frame: Within 12 months after the surgery ]
    Risk factors defined in terms of number of lymphnodes removed, site of lymphnodes, peri- and postoperative complications, adjuvant chemotherapy, adjuvant radiation therapy, age, histopathological subtype, surgical FIGO stage, DNA-ploidy status of the tumor, comorbidity and relapse of the cancer.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02115477


Contacts
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Contact: Preben Kjölhede, MD, PhD +46101033187 Preben.Kjolhede@liu.se
Contact: Per Rosenberg, MD, PhD +46101032017 Per.Rosenberg@regionostergotland.se

Locations
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Sweden
Highland hospital Recruiting
Eksjo, Jonkopings län, Sweden, 57533
Contact: Lisbeth Liest, MD    +4638135000    Lisbeth.Liest@rjl.se   
Principal Investigator: Lisbeth Liest, MD         
Falu Central Hospital Recruiting
Falun, Sweden, 79182
Contact: Åsa Nyberg, MD, PhD       asa.nyberg@ltdalarna.se   
Principal Investigator: Åsa Nyberg, MD, PhD         
Gävle County Hospital Recruiting
Gävle, Sweden, 80187
Contact: Peter Smith, MD, PhD    +4626154165    peter.smith@lg.se   
Principal Investigator: Peter Smith, MD, PhD         
Sahlgrenska University Hospital Recruiting
Göteborg, Sweden, 41345
Contact: Åsa Åkesson, MD, PhD    +46313429234    asa.e.akesson@vgregion.se   
Principal Investigator: Åsa Åkesson, MD, PhD         
Region Halland Halmstad Hospital Recruiting
Halmstad, Sweden, 30233
Contact: Magnus Lindahl, MD, PhD    +4635147784    magnus.lindahl@regionhalland.se   
Principal Investigator: Magnus Lindahl, MD, PhD         
County Hospital in Kalmar Recruiting
Kalmar, Sweden, 39185
Contact: Gunnel Lindell, MD, PhD       Gunnel.Lindell@ltkalmar.se   
Principal Investigator: Gunnel Lindell, MD, PhD         
Blekinge Hospital Recruiting
Karlskrona, Sweden, 37185
Contact: Eva Rundqvist, MD, PhD    +46455174624    eva.rundqvist@ltblekinge.se   
Principal Investigator: Eva Rundqvist, MD, PhD         
Karlstad Central Hospital Recruiting
Karlstad, Sweden, 65185
Contact: Margareta Lood, MD    +4654615144    margareta.lood@liv.se   
Principal Investigator: Margareta Lood, MD         
Linkoping University Hospital Recruiting
Linkoping, Sweden, 58185
Contact: Preben Kjolhede, MD, PhD    +46101033187    Preben.Kjolhede@liu.se   
Principal Investigator: Preben Kjolhede, MD, PhD         
Sub-Investigator: Madelene Olsson, MD         
Södra Älvborgs Sjukhus Recruiting
Skövde, Sweden, +4651085000
Contact: Lars Högström, MD, PhD    +4651085000    Lars.Hogstrom@vgregion.se   
Principal Investigator: Lars Högström, MD         
Sundsvall Hospital Recruiting
Sundsvall, Sweden, 85186
Contact: Lotta Andreén, MD, PhD    +4660181000    lotta.andreen@lvn.se   
Principal Investigator: Lotta Andreén, MD, PhD         
Norra Älvborgs Hospital Recruiting
Trollhättan, Sweden, 46185
Contact: Eva Blank, MD, PhD    +46104352264    eva.blank@vgregion.se   
Principal Investigator: Eva Blank, MD, PhD         
Norrlands University Hospital Recruiting
Umeå, Sweden, 90185
Contact: Ulrika Ottander, MD, PhD    +46907850000    ulrika.ottander@obgyn.umu.se   
Contact: Kristina Aglund, MD, PhD    +46907850000    kristina.aglund@vll.se   
Principal Investigator: Ulrika Ottander, MD, PhD         
Sub-Investigator: Kristina Aglund, MD, PhD         
Akademiska University Hospital Recruiting
Uppsala, Sweden, 75185
Contact: Karin Stålberg, MD, PhD    +46186110000    Karin.Stalberg@kbh.uu.se   
Principal Investigator: Karin Stålberg, MD, PhD         
Region Halland Varberg hospital Recruiting
Varberg, Sweden, 43281
Contact: Janusz Marcickiewicz, MD, PhD    +46340647990    Janusz.Marcickiewicz@regionhalland.se   
Principal Investigator: Janusz Marcickiewicz, MD, PhD         
Västervik County Hospital Recruiting
Västervik, Sweden, 59381
Contact: Anders Rosenmuller, MD    +4649086000    anders.rosenmuller@ltkalmar.se   
Principal Investigator: Anders Rosenmuller, MD         
Sponsors and Collaborators
Preben Kjolhede, MD, professor
Swedish Cancer Society
Medical Research Council of Southeast Sweden
Ostergotland County Council, Sweden
Linkoeping University
Investigators
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Study Chair: Preben Kjölhede, MD, PhD Dept of Obs/Gyn, University Hospital, Linköping
Study Chair: Per Rosenberg, MD,PhD Dept of Oncology, University Hospital, Linköping
Study Chair: Gabriel Lindahl, MD Dept of Oncology, University Hospital, Linköping
Study Chair: Eva Ahlner, RPT Dept of Oncology, University Hospital, Linköping
Study Chair: Janusz Marcickiewicz, MD, PhD Dept of Obs/Gyn, Region Halland Varberg Hospital, Varberg
Study Chair: Karin Stålberg, MD, PhD Dept of Obs/Gyn, Univeristy Hospital, Uppsala
Principal Investigator: Ulrika Ottander, MD, PhD Dept of Obs/Gyn, Norrlands University Hospital, Umeå
Principal Investigator: Kristina Aglund, MD, PhD Dept of Oncology, Norrlands University Hospital, Umeå
Principal Investigator: Åsa Åkesson, MD, PhD Dept of Obs/Gyn, Sahlgrenska University Hospital, Göteborg
Principal Investigator: Eva Blank, MD, PhD Dept of Obs/Gyn, Norra Älvsborg County Hospital in Trollhättan, Trollhättan
Principal Investigator: Lars Högström, MD, PhD Dept of Obs/Gyn, Södra Älvsborgs Hospital, Borås
Principal Investigator: Eva Rundqvist, MD Dept of Obs/Gyn, Blekinge Hospital, Karlskrona
Principal Investigator: Margareta Lood, MD Dept of Obs/Gyn, Central Hospital, Karlstad
Principal Investigator: Lotta Andreen, MD, PhD Dept of Obs/Gyn, Central Hospital, Sundsvall
Principal Investigator: Peter Smith, MD, PhD Dept of Obs/Gyn, Central Hospital, Gävle
Principal Investigator: Åsa Nyberg, MD, PhD Dept of Obs/Gyn, Central Hospital, Falun
Principal Investigator: Lisbeth Liest, MD Dept of Obs/Gyn, Highland Hospital, Eksjö
Principal Investigator: Gunnel Lindell, MD, PhD Dept of Obs/Gyn, Kalmar County Hospital, Kalmar
Principal Investigator: Anders Rosenmüller, MD Dept of Obs/Gyn, Västervik County Hospital, Västervik

Publications:
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Responsible Party: Preben Kjolhede, MD, professor, Professor, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT02115477     History of Changes
Other Study ID Numbers: Version 2013-09-22/2014-03-21
The Swedish Cancer Society ( Other Grant/Funding Number: CAN 2013/620 )
First Posted: April 16, 2014    Key Record Dates
Last Update Posted: February 23, 2016
Last Verified: February 2016
Keywords provided by Preben Kjolhede, MD, professor, University Hospital, Linkoeping:
Uterus cancer
Hysterectomy
Lymphadenectomy
Lymphedema
Additional relevant MeSH terms:
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Carcinoma
Lymphedema
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Lymphatic Diseases