Gynecological CancerNCT05003973
The Effectiveness of Anti-resistance Exercise on Lower Limb Lymphoedema Among Gynecological Cancer
A study testing home-based anti-resistance exercise and usually care in people with Gynecological Cancer and Lower Limb Lymphedema, run by National Cheng Kung University.
Trial summary
Background: The incidence of lower limb lymphedema (LLL) after gynecological cancer surgery with lymphadenectomy is about 10-46%. Lower limb lymphedema results in limited physical mobility and reduced patients' quality of life. Read more about this study
- Who is it for?
- Ages 20 to 75 years, women only
- Conditions the study is for
- Gynecological Cancer, Lower Limb Lymphedema
- What is being tested?
- home-based anti-resistance exercise and usually care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2021to 31 Dec 2023
- 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 20 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women with gynecological cancer surgery
- aged of 20-75 years
- currently have lower extremity lymphedema.
Who cannot join
- heart failure
- kidney failure
- DVT
- limb surgery
Trial locations and contacts
No sites are listed yet.
About this study
Background:
The incidence of lower limb lymphedema (LLL) after gynecological cancer surgery with lymphadenectomy is about 10-46%. Lower limb lymphedema results in limited physical mobility and reduced patients' quality of life. A hospital -based complete decongestive therapy has been recommended to patients with LLL, including exercise, manual lymphatic drainage, compression therapy, and skin care. However, the inconvenience of the hospital-based rehabilitation program limit the availability for those patients LLL. Home-based exercise program may be feasible instead of the hospital-based program. Few studies have evaluated the effectiveness of the home-based lower extremity exercise on reliving LLL and improving quality of life in patients with LLL.
Read more
Research Purposes:
The main purpose of the study is to evaluate the effectiveness of a home-based exercise program for relieving lower extremity lymphedema, including circumference measurement, bioimpedance spectroscopy (BIS), lower limb muscle strength, quality of life related to cancer \& LLL, and fatigue.
Methods:
This study is a two- year project with a single-blind randomized clinical trial. The participants are women with gynecological cancer surgery, aged of 20-75 years and currently have lower extremity lymphedema. A sample of 76 participants will be stratified randomly assigned to an experimental group or a control group. The experimental group is to carry out a home-based anti-resistance exercise with elastic band other than a routine care of complex decongestive physiotherapy; while the control group is to carry out a routine care of complex decongestive physiotherapy. The home-based program is a 12-week exercise program. Data collections will be conducted before exercise (Baseline), during exercise (second months), and exercise program after completion. Measures includes (1) Physical examination: limb leg circumference measurement, bioimpedance spectroscopy (BIS), lower limb muscle strength, (2) Questionnaires: Functional status of lymphatic edema of LLL, fatigue, and EORTC-QLQ-C30.
Anticipated Outcomes:
Findings from this study could provide a reference of home-based exercise guideline and be integrated into the care of activities for women following gynecological surgery with LLL.
- Conditions
- Gynecological Cancer, Lower Limb Lymphedema
- Being tested
- home-based anti-resistance exercise, usually care
- Keywords
- Women's Health, Home-based Anti-Resistance Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home-based anti-resistance exerciseBehavioural
It is a 12-week, middle-level, home-based, anti-resistance exercise. Exercise was recommended 1-2 times per day for 15-20 mins per session.
usually careBehavioural
The leaflet of the lymphedema self-care, including skin care and manual lymphatic drainage
| Study group | Role | What they receive |
|---|---|---|
| home-based anti-resistance exercise | Experimental | Not described Receives: Behavioral: home-based anti-resistance exercise; Behavioral: usually care |
| usually care | Experimental | Not described Receives: Behavioral: usually care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limb circumference change from baseline to 3 months
Measuring by measuring tape
Measured: from baseline to 3 months
Edema change from baseline to 3 months
Measuring by Bioelectrical Impedance Spectroscopy (BIS)- InBody S10
Measured: from baseline to 3 months
Lower limb muscle strength change from baseline to 3 months
Measuring by microFET 2
Measured: from baseline to 3 months
Functional status of lymphatic edema of LLL change from baseline to 3 months
Measuring by Lymphoedema Functioning, Disability and Health Questionnaire for Lower Limb Lymphoedema (Lymph-ICF-LL). It is a 28-item, 0(no problem) to 10(very severe) questionnaire.
Measured: from baseline to 3 months
Fatigue change from baseline to 3 months
Measuring by Chinese Lee Fatigue Scale Short Form (C-LESSF). It is a 7-item, from 0(no fatigue) to 10(very fatigue) questionnaire.
Measured: from baseline to 3 months
EORTC-QLQ-C30
Measuring by EORTC QLQ C30. It is a 30-item, from 0(no problem) to 10(very severe) questionnaire.
Measured: from baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start20 Aug 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gynecological 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng Kung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Yun Hsu, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003973
- Sponsor's protocol ID
- A-ER-107-433
- Status last verified
- Aug 2021
- First submitted
- 26 Jul 2021
- Last updated
- 13 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518.
PubMed 39606939
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Anti-resistance Exercise on Lower Limb Lymphoedema Among Gynecological Cancer
- ClinicalTrials.gov ID
- NCT05003973
- Acronym / sponsor ID
- A-ER-107-433
- Conditions
- Gynecological Cancer, Lower Limb Lymphedema
- Keywords
- Women's Health, Home-based Anti-Resistance Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Cheng Kung UniversityUniversity, hospital or other
- Study start
- 20 Aug 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 13 Aug 2021 (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.
Background:
The incidence of lower limb lymphedema (LLL) after gynecological cancer surgery with lymphadenectomy is about 10-46%. Lower limb lymphedema results in limited physical mobility and reduced patients' quality of life. A hospital -based complete decongestive therapy has been recommended to patients with LLL, including exercise, manual lymphatic drainage, compression therapy, and skin care. However, the inconvenience of the hospital-based rehabilitation program limit the availability for those patients LLL. Home-based exercise program may be feasible instead of the hospital-based program. Few studies have evaluated the effectiveness of the home-based lower extremity exercise on reliving LLL and improving quality of life in patients with LLL.
Research Purposes:
The main purpose of the study is to evaluate the effectiveness of a home-based exercise program for relieving lower extremity lymphedema, including circumference measurement, bioimpedance spectroscopy (BIS), lower limb muscle strength, quality of life related to cancer \& LLL, and fatigue.
Methods:
This study is a two- year project with a single-blind randomized clinical trial. The participants are women with gynecological cancer surgery, aged of 20-75 years and currently have lower extremity lymphedema. A sample of 76 participants will be stratified randomly assigned to an experimental group or a control group. The experimental group is to carry out a home-based anti-resistance exercise with elastic band other than a routine care of complex decongestive physiotherapy; while the control group is to carry out a routine care of complex decongestive physiotherapy. The home-based program is a 12-week exercise program. Data collections will be conducted before exercise (Baseline), during exercise (second months), and exercise program after completion. Measures includes (1) Physical examination: limb leg circumference measurement, bioimpedance spectroscopy (BIS), lower limb muscle strength, (2) Questionnaires: Functional status of lymphatic edema of LLL, fatigue, and EORTC-QLQ-C30.
Anticipated Outcomes:
Findings from this study could provide a reference of home-based exercise guideline and be integrated into the care of activities for women following gynecological surgery with LLL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| home-based anti-resistance exercise | Experimental | Behavioral: home-based anti-resistance exercise, Behavioral: usually care |
| usually care | Experimental | Behavioral: usually care |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- women with gynecological cancer surgery
- aged of 20-75 years
- currently have lower extremity lymphedema.
Key exclusion criteria (4 listed)
- heart failure
- kidney failure
- DVT
- limb surgery
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 |
|---|---|---|
| home-based anti-resistance exerciseIt is a 12-week, middle-level, home-based, anti-resistance exercise. Exercise was recommended 1-2 times per day for 15-20 mins per session. | Behavioural | home-based anti-resistance exercise |
| usually careThe leaflet of the lymphedema self-care, including skin care and manual lymphatic drainage | Behavioural | home-based anti-resistance exercise, usually care |
Primary outcome
Limb circumference change from baseline to 3 months
Time frame: from baseline to 3 months
Measuring by measuring tape
Edema change from baseline to 3 months
Time frame: from baseline to 3 months
Measuring by Bioelectrical Impedance Spectroscopy (BIS)- InBody S10
Lower limb muscle strength change from baseline to 3 months
Time frame: from baseline to 3 months
Measuring by microFET 2
Functional status of lymphatic edema of LLL change from baseline to 3 months
Time frame: from baseline to 3 months
Measuring by Lymphoedema Functioning, Disability and Health Questionnaire for Lower Limb Lymphoedema (Lymph-ICF-LL). It is a 28-item, 0(no problem) to 10(very severe) questionnaire.
Fatigue change from baseline to 3 months
Time frame: from baseline to 3 months
Measuring by Chinese Lee Fatigue Scale Short Form (C-LESSF). It is a 7-item, from 0(no fatigue) to 10(very fatigue) questionnaire.
EORTC-QLQ-C30
Time frame: from baseline to 3 months
Measuring by EORTC QLQ C30. It is a 30-item, from 0(no problem) to 10(very severe) questionnaire.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- Derived from this study: PubMed 39606939Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518.
- Individual participant dataSharing planned: Undecided
Related trials for Gynecological Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruitingPhase 2
A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV7/ ENGOT-ov80 Study)
Ovarian Neoplasms, Endometrial Neoplasms
RecruitingPhase 1/2
A Study of Mocertatug Rezetecan in Combination With Anti-cancer Therapies for Advanced Solid Tumors (BEHOLD-2)
Tumours, Gynecological
Active, not recruitingObservational study
Diet, Hepcidin, and Chemotherapy RDI
Breast Cancer Female, Ovarian Cancer
RecruitingObservational study
GYNGHER - HER2 Expression in Gynecological Malignancies: a Brazilian Cohort
Gynaecological Cancers
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.
Questions about this trial
What is this clinical trial studying?
A study testing home-based anti-resistance exercise and usually care in people with Gynecological Cancer and Lower Limb Lymphedema, run by National Cheng Kung University.
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 4 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 13 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Yun Hsu (+886-6-2353535, yuht12@mail.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Limb circumference change from baseline to 3 months (time frame: from baseline to 3 months). The study lists 6 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 NCT05003973, which also lists 1 linked publication.
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 Aug 2021.