Lymphedema of Upper LimbNCT04766489
Evaluation of the Treatment Response in Breast Cancer Related Lymphedema
A study testing Complete Decongtestive Therapy in people with Lymphedema of Upper Limb and Breast Cancer, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effects of the treatment for breast cancer lymphedema. After taking a detailed history and giving a physical examination, breast cancer related lymphedema patients(n:30) will be informed and will be given Complete Decongestive Therapy, which includes decongestive exercises, manual… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphedema of Upper Limb, Breast Cancer, Breast Cancer Lymphedema
- What is being tested?
- Complete Decongtestive Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Jul 2019to 11 Dec 2019
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral lymphedema of the arm after mastectomy for breast cancer
Who cannot join
- Bilateral lymphedema
- Primary bone tumor and/or metastasis
- Patients with ongoing radiotherapy
- Circulation disorders of the upper extremity(eg; peripheral vascular disease, thrombosis)
- Patients with infectious lymphedema/elephantiasis
- Presence of local infection in upper extremities(cellulitis) and/or presence of severe systemic infection
Show all 10Show fewer
- Carcinomatous lymphangitis
- Congestive heart failure(NYHA class 3 or 4)
- History of prosthesis on upper extremities
- Use of drugs which may alter the fluid or electrolyte balance
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Faculty of Medicine
Izmir, Bornova, 35100
About this study
Official title: Evaluation of the Treatment Response in Breast Cancer Related Lymphedema After Mastectomy Surgery
This study aims to evaluate the effects of the treatment for breast cancer lymphedema. After taking a detailed history and giving a physical examination, breast cancer related lymphedema patients(n:30) will be informed and will be given Complete Decongestive Therapy, which includes decongestive exercises, manual lymphatic drainage, compression therapy(either through short stretch bandaging and/or pneumatic device) and exercise. Patients will be evaluated with limb volume, lymphedema index acquired through bioimpedance device, QuickDASH for upper extremity function, hand dynamometer for upper extremity grip strength and CLUE(Breast Cancer-Related Lymphedema of the Upper Extremity standardized clinical evaluation tool) scoring for lymphedema before and after the intervention. The values will be compared in order to show whether there are significant differences between before and after scores, and whether CLUE score is correlated with the other indicators of breast cancer related lymphedema.
- Being tested
- Complete Decongtestive Therapy
- Keywords
- Lymphedema, Mastectomy, Breast Cancer
- Medical subject headings
- Breast Neoplasms, Breast Cancer Lymphedema, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete Decongtestive TherapyProcedure or surgery
Also called Aggresive treatment phase for lymphedema
Patients will be given complete decongestive therapy, which includes decongestive exercises, manual lymphatic drainage, compression therapy(either through short stretch bandaging and/or pneumatic device) and exercise, for 5 days a week and for a mean of 20 sessions. Each session will be of 1 hour duration for compressive therapies(Short stretch bandages will be left on for 23 hours a day), 30 minutes of manual lymphatic drainage, and decongestive exercises 3 times a day for 15 minutes each time.
| Study group | Role | What they receive |
|---|---|---|
| Complete Deongestive Therapy | Experimental | Patients will be given complete decongestive therapy for 5 days a week and for a mean of 20 sessions. Each session will be of approximately 2 hours and 15 minutes in duration, although short stretch bandaging will be left on for 23 hours a day. Receives: Procedure: Complete Decongtestive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
CLUE score
Breast Cancer-Related Lymphedema of the Upper Extremity (CLUE) is a standardized clinical evaluation tool which was developed to evaluate the severity of the lymphedema, especially in the context of clinical trials. CLUE involves assessing obscuration of anatomical architecture (eg, bony prominences, tendons), deviation from normal anatomical contour, change of soft-tissue texture, and the presence of pitting or nonpitting edema. It consists of these four assessments conducted in three different parts or the upper extremity(arm, forearm and hand). CLUE scores have a range of 0 to 72, with greater numbers associated with more severe lymphedema. It was shown to be valid and reliable for the assessment of breast cancer related lymphedema by Spinelli et al.(1)
Measured: 1 month
Secondary outcomes (4)
Hand Grip Strength
Hand grip strength: Hand grip strength will be measured using JAMAR® hand dynamometer. It has been used to assess hand grip strength in many studies over half a century. Patients will be asked to sit down with shoulder adducted, elbow flexed (90°) and forearm in the neutral position. Mean of the 3 measurements taken with 1 minute apart from each other will be recorded. Patients' measurements will be taken for both affected and unaffected arm, and will be recorded as kgf.
Measured: 1 Month
Extremity volume
Volume measurements will be taken using ulnar styloid process as a index point, and circumferential measurements were taken with 5 cm spaces from distal to the proximal. Using a computer programme (Limb Volumes Professional version 5.0), the total volume of the arm will be calculated and recorded before and after the treatment for both arms.
All patients' measurements will be taken by the same researcher, who happens to be experienced in this field.
Measured: 1 Month
Lymphedema index
Lymphedema index will be acquired with a bioimpedance spectroscopy device (L-DEX U400, ImpediMed Limited, Brisbane-Australia). The device utilizes the characteristics of frequency dependent current flow to quantify changes in extracellular fluid in the patient's limb. The lymphedema index value increases on the scale with the higher levels of extracellular fluid, which is directly associated with the presence of lymphedema.
Measured: 1 Month
QuickDASH
Short version of the Disabilities of the Arm, Shoulder, and Hand Questionnaire(Quick-DASH) will be used to assess the function of the upper extremities. The Quick-DASH contains 11 items (scored 1-5) and reflects both function and pain in persons with musculoskeletal disorders of the upper extremity. To be able to calculate a score, at least 10 of the 11 items must be completed. The overall score ranges from 0 to 100 points with higher score representing greater disability.
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start11 Jul 2019
- Primary completion11 Dec 2019
- Study completion11 Dec 2019
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 Lymphedema of Upper LimbStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Göksel Tanıgör M.D., Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766489
- Sponsor's protocol ID
- CLUE-BCL
- Status last verified
- Feb 2021
- First submitted
- 20 Feb 2021
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans of sharing data.
Publications
Spinelli B, Kallan MJ, Zhang X, Cheville A, Troxel A, Cohn J, Dean L, Sturgeon K, Evangelista M, Zhang Z, Ebaugh D, Schmitz KH. Intra- and Interrater Reliability and Concurrent Validity of a New Tool for Assessment of Breast Cancer-Related Lymphedema of the Upper Extremity. Arch Phys Med Rehabil. 2019 Feb;100(2):315-326. doi: 10.1016/j.apmr.2018.08.185. Epub 2018 Oct 4.
PubMed 30291828
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Treatment Response in Breast Cancer Related Lymphedema After Mastectomy Surgery
- ClinicalTrials.gov ID
- NCT04766489
- Acronym / sponsor ID
- CLUE-BCL
- Keywords
- Lymphedema, Mastectomy, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 11 Jul 2019 (actual)
- Primary completion
- 11 Dec 2019 (actual)
- Study completion
- 11 Dec 2019 (actual)
- First posted
- 23 Feb 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.
This study aims to evaluate the effects of the treatment for breast cancer lymphedema. After taking a detailed history and giving a physical examination, breast cancer related lymphedema patients(n:30) will be informed and will be given Complete Decongestive Therapy, which includes decongestive exercises, manual lymphatic drainage, compression therapy(either through short stretch bandaging and/or pneumatic device) and exercise. Patients will be evaluated with limb volume, lymphedema index acquired through bioimpedance device, QuickDASH for upper extremity function, hand dynamometer for upper extremity grip strength and CLUE(Breast Cancer-Related Lymphedema of the Upper Extremity standardized clinical evaluation tool) scoring for lymphedema before and after the intervention. The values will be compared in order to show whether there are significant differences between before and after scores, and whether CLUE score is correlated with the other indicators of breast cancer related lymphedema.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Complete Deongestive Therapy | Experimental | Procedure: Complete Decongtestive TherapyPatients will be given complete decongestive therapy for 5 days a week and for a mean of 20 sessions. Each session will be of approximately 2 hours and 15 minutes in duration, although short stretch bandaging will be left on for 23 hours a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Unilateral lymphedema of the arm after mastectomy for breast cancer
Key exclusion criteria (10 listed)
- Bilateral lymphedema
- Primary bone tumor and/or metastasis
- Patients with ongoing radiotherapy
- Circulation disorders of the upper extremity(eg; peripheral vascular disease, thrombosis)
- Patients with infectious lymphedema/elephantiasis
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 |
|---|---|---|
| Complete Decongtestive TherapyAlso: Aggresive treatment phase for lymphedemaPatients will be given complete decongestive therapy, which includes decongestive exercises, manual lymphatic drainage, compression therapy(either through short stretch bandaging and/or pneumatic device) and exercise, for 5 days a week and for a mean of 20 sessions. Each session will be of 1 hour duration for compressive therapies(Short stretch bandages will be left on for 23 hours a day), 30 minutes of manual lymphatic drainage, and decongestive exercises 3 times a day for 15 minutes each time. | Procedure or surgery | Complete Deongestive Therapy |
Primary outcome
CLUE score
Time frame: 1 month
Breast Cancer-Related Lymphedema of the Upper Extremity (CLUE) is a standardized clinical evaluation tool which was developed to evaluate the severity of the lymphedema, especially in the context of clinical trials. CLUE involves assessing obscuration of anatomical architecture (eg, bony prominences, tendons), deviation from normal anatomical contour, change of soft-tissue texture, and the presence of pitting or nonpitting edema. It consists of these four assessments conducted in three different parts or the upper extremity(arm, forearm and hand). CLUE scores have a range of 0 to 72, with greater numbers associated with more severe lymphedema. It was shown to be valid and reliable for the assessment of breast cancer related lymphedema by Spinelli et al.(1)
4 secondary outcomes
Hand Grip Strength
Time frame: 1 Month
Extremity volume
Time frame: 1 Month
Lymphedema index
Time frame: 1 Month
QuickDASH
Time frame: 1 Month
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 23 Feb 2021.
- Results publication: PubMed 30291828Spinelli B, Kallan MJ, Zhang X, Cheville A, Troxel A, Cohn J, Dean L, Sturgeon K, Evangelista M, Zhang Z, Ebaugh D, Schmitz KH. Intra- and Interrater Reliability and Concurrent Validity of a New Tool for Assessment of Breast Cancer-Related Lymphedema of the Upper Extremity. Arch Phys Med Rehabil. 2019 Feb;100(2):315-326. doi: 10.1016/j.apmr.2018.08.185. Epub 2018 Oct 4.
- Individual participant dataSharing planned: No. No plans of sharing data.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complete Decongtestive Therapy in people with Lymphedema of Upper Limb and Breast Cancer, run by Ege University at 1 site in Turkey (Türkiye).
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 1 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: finished, as of the sponsor's last update on 23 Feb 2021. 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 Turkey (Türkiye). 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?
CLUE score (time frame: 1 month). 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 NCT04766489, 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 23 Feb 2021; AzTrials last refreshed its copy on 8 Nov 2026.