Gynecologic CancerPhase 3NCT01849224
Randomized Trial of Exercise on Lower Extremity Edema After Lymphadenectomy in Gynecologic Cancer
A Phase 3 study testing Pelvic and lower extremity exercise in people with Gynecologic Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
The primary outcome is the change in lower extremity edema-related symptoms. Secondary outcomes include the compliance rate of management guidelines for lower extremity edema, the performance rate for pelvic and lower extremity exercise. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancer
- What is being tested?
- Pelvic and lower extremity exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2013to Dec 2015
- Phase
- Phase 3
- 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
- More than 18 years of age
- Patients who underwent pelvic lymphadenectomy
- Patients with suspicious pelvic cancer who finished active treatments such as chemotherapy, radiotherapy or surgery. The interval between the time of randomization and the end of the treatment should be more than 2 weeks.
- The patient is able to understand the study and is willing to give written informed consent to the study
- patient with edema-related symptoms such as leg heaviness, distension, tightness, pain, limited movement, or weakness etc.
Who cannot join
- Severe systemic diseases causing peripheral edema, including renal disease
- Severe or uncontrolled cardiopulmonary disease, including implantable device such as a pacemaker
- Acute superficial or deep vein thrombosis
- Previous major surgery for lower extremities, including metallic surgical implant
- Local infection in the lower extremities
- Auto-immunological disorders or vasculitis
Show all 10Show fewer
- Use of systemic corticosteroids
- Pregnant or currently breastfeeding
- Alcohol or drug abuse
- Uncontrolled diabetes
Trial locations and contacts
1 site in 1 country.
JeongSeon Lee contact
South Korea1 site, 1 recruiting
- Recruiting
Myong Cheol Lim
Goyang-si, Gyeonggi-do, 410-769
Myong Cheol Lim, gynlim@gmail.com
Myong Cheol Lim
About this study
Official title: Randomized Trial of Pelvic and Lower Extremity Exercise in Patients Who Underwent Pelvic Lymphadenectomy With Lower Extremity Edema-related Symptoms
The primary outcome is the change in lower extremity edema-related symptoms. Secondary outcomes include the compliance rate of management guidelines for lower extremity edema, the performance rate for pelvic and lower extremity exercise.
- Conditions
- Gynecologic Cancer
- Being tested
- Pelvic and lower extremity exercise
- Keywords
- Lower extremity edema, Lower leg lymphedema, Lower leg edema, Lymphedema, Pelvic lymphadenectomy, Exercise
- Medical subject headings
- Lymphedema, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic and lower extremity exerciseOther
| Study group | Role | What they receive |
|---|---|---|
| Pelvic and lower extremity exercise | Experimental | Experimental arm will be educated the guidelines for prevention and early detection of lower extremity edema. Additionally, pelvic and lower extremity exercise will be educated and participants will continue exercise for 1 year at home. Receives: Other: Pelvic and lower extremity exercise |
| Control | No intervention | Control group will be educated the guidelines for prevention and early detection of lower extremity edema |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lower extremity edema-related symptoms after pelvic and lower extremities exercise
Measured: 1 year after randomization
Secondary outcomes (1)
the compliance rate of management guidelines for lower extremity edema, the performance rate for pelvic and lower extremity exercise
Measured: 1 year after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Myong Cheol Lim, National Cancer Center, Korea
- Investigators
- Lim Myong Cheol, MD,PhD, Principal investigator, National Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01849224
- Sponsor's protocol ID
- NCCNCS-13-723
- Status last verified
- Jul 2013
- First submitted
- 6 May 2013
- Last updated
- 16 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Pelvic and Lower Extremity Exercise in Patients Who Underwent Pelvic Lymphadenectomy With Lower Extremity Edema-related Symptoms
- ClinicalTrials.gov ID
- NCT01849224
- Acronym / sponsor ID
- NCCNCS-13-723
- Conditions
- Gynecologic Cancer
- Keywords
- Lower extremity edema, Lower leg lymphedema, Lower leg edema, Lymphedema, Pelvic lymphadenectomy, Exercise
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- May 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 8 May 2013 (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 primary outcome is the change in lower extremity edema-related symptoms. Secondary outcomes include the compliance rate of management guidelines for lower extremity edema, the performance rate for pelvic and lower extremity exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic and lower extremity exercise | Experimental | Other: Pelvic and lower extremity exerciseExperimental arm will be educated the guidelines for prevention and early detection of lower extremity edema. Additionally, pelvic and lower extremity exercise will be educated and participants will continue exercise for 1 year at home. |
| Control | No intervention | –Control group will be educated the guidelines for prevention and early detection of lower extremity edema |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- More than 18 years of age
- Patients who underwent pelvic lymphadenectomy
- Patients with suspicious pelvic cancer who finished active treatments such as chemotherapy, radiotherapy or surgery. The interval between the time of randomization and the end of the treatment should be more than 2 weeks.
- The patient is able to understand the study and is willing to give written informed consent to the study
- patient with edema-related symptoms such as leg heaviness, distension, tightness, pain, limited movement, or weakness etc.
Key exclusion criteria (10 listed)
- Severe systemic diseases causing peripheral edema, including renal disease
- Severe or uncontrolled cardiopulmonary disease, including implantable device such as a pacemaker
- Acute superficial or deep vein thrombosis
- Previous major surgery for lower extremities, including metallic surgical implant
- Local infection in the lower extremities
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 |
|---|---|---|
| Pelvic and lower extremity exercise | Other | Pelvic and lower extremity exercise |
Primary outcome
Change in lower extremity edema-related symptoms after pelvic and lower extremities exercise
Time frame: 1 year after randomization
1 secondary outcome
the compliance rate of management guidelines for lower extremity edema, the performance rate for pelvic and lower extremity exercise
Time frame: 1 year after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2013.
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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.
JeongSeon Lee contact
Lim Myong Cheol, MD,PhD principal investigator
National Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pelvic and lower extremity exercise in people with Gynecologic Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
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 10 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: status not confirmed, as of the sponsor's last update on 16 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Myong Cheol Lim, MD, PhD (+82-31-920-1760, gynlim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lower extremity edema-related symptoms after pelvic and lower extremities exercise (time frame: 1 year after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2013.