Lymphedema ArmNCT03945838
Assessment of Muscle Strength and Volume Changes in Patients With Breast Cancer- Related Lymphedema
An observational study of Lymphedema Arm and Lymphedema; Surgical, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to find whether complete decongestive therapy used in breast cancer-related lymphedema has an effect on muscle strength in the affected arm, while assessing the efficacy of the therapy itself. 74 patients with breast cancer related lymphedema were included in this study. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Lymphedema Arm, Lymphedema; Surgical
- What is being tested?
- Complete Decongestion Therapy
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Apr 2017to 24 Apr 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients between 18-70 years old with a history of mastectomy or breast conserving surgery and lymphedema * Having a certain diagnosis of lymphedema
Who may be able to join
- Having had mastectomy or breast conserving surgery
- Having a certain diagnosis of lymphedema with a difference in arm circumferences more than 1 cm
Who cannot join
- The subjects with active infection or cancer with metastases, the ones who didn't accept the complete decongestive therapy, patients with vascular disease, rheumatic disease, upper limb deformity, any upper limb surgery history, bilateral lymphedema or a history of transplantation were excluded
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege university school of medicine
Izmir, 35100
About this study
This study aims to find whether complete decongestive therapy used in breast cancer-related lymphedema has an effect on muscle strength in the affected arm, while assessing the efficacy of the therapy itself. 74 patients with breast cancer related lymphedema were included in this study. Patients were taken their demographic and clinical history and were evaluated with measurements of extremity volumes and hand grip strengths using a hand dynamometer before and after the complete decongestive therapy. Data were then assessed using relevant statistical methods.
- Conditions
- Lymphedema Arm, Lymphedema; Surgical
- Being tested
- Complete Decongestion Therapy
- Keywords
- Lymphedema, Hand grip strength, Breast cancer related lymphedema, Complete decongestion therapy
- Medical subject headings
- Lymphedema, Breast Cancer Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete Decongestion TherapyOther
It is given in two phases. First phase includes intensive therapy which aims to reduce the volume of the extremity. Second phase aims to preserve these reductions of volume.
All patients were prescribed lymphedema specific exercises and were advised to walk (for 30 minutes everyday) daywhile taking complete decongestive therapy. They were specifically informed that exercise does not aggravate the severity of their lymphedema.
Short stretch bandages were applied to the patients with self manual lymphatic drainage. Intensive phase was given 5 days a week, and short stretch bandages applied for 23 hours a day with 1 hour interval. To increase the local pressure on the areas required, foams were added. Patients were screened with arm circumferential measurements once a week. After gaining a plateau in the volumes, patients were prescribed compression garments.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer related lymphedema | All patients were included in the complete decongestive therapy programme. This therapy includes patient education, skin care, exercises, manual lymphatic drainage (self), and compression bandage therapy. Receives: Other: Complete Decongestion Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand grip strength
Hand grip strength: Hand grip strength was measured using JAMAR® hand dynamometer. It has been used to assess hand grip strength in many studies over half a century. Patients were 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 was recorded. Patients' measurements were taken for both affected and unaffected arm, and recorded as kgf.
Measured: 3 weeks
Extremity volume
Volume measurements were 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 was calculated and recorded before and after the treatment for both arms.
All patients' measurements were taken by the same researcher.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start4 Apr 2017
- Primary completion24 Apr 2018
- Study completion24 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphedema ArmStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 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
- NCT03945838
- Sponsor's protocol ID
- LymphHG
- Status last verified
- May 2019
- First submitted
- 8 May 2019
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Muscle Strength and Volume Changes in Patients With Breast Cancer- Related Lymphedema
- ClinicalTrials.gov ID
- NCT03945838
- Acronym / sponsor ID
- LymphHG
- Conditions
- Lymphedema Arm, Lymphedema; Surgical
- Keywords
- Lymphedema, Hand grip strength, Breast cancer related lymphedema, Complete decongestion therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- 24 Apr 2018 (actual)
- Study completion
- 24 Apr 2018 (actual)
- First posted
- 10 May 2019 (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 find whether complete decongestive therapy used in breast cancer-related lymphedema has an effect on muscle strength in the affected arm, while assessing the efficacy of the therapy itself. 74 patients with breast cancer related lymphedema were included in this study. Patients were taken their demographic and clinical history and were evaluated with measurements of extremity volumes and hand grip strengths using a hand dynamometer before and after the complete decongestive therapy. Data were then assessed using relevant statistical methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer related lymphedema | – | Other: Complete Decongestion TherapyAll patients were included in the complete decongestive therapy programme. This therapy includes patient education, skin care, exercises, manual lymphatic drainage (self), and compression bandage therapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients between 18-70 years old with a history of mastectomy or breast conserving surgery and lymphedema * Having a certain diagnosis of lymphedema
Key inclusion criteria (2 listed)
- Having had mastectomy or breast conserving surgery
- Having a certain diagnosis of lymphedema with a difference in arm circumferences more than 1 cm
Key exclusion criteria (1 listed)
- The subjects with active infection or cancer with metastases, the ones who didn't accept the complete decongestive therapy, patients with vascular disease, rheumatic disease, upper limb deformity, any upper limb surgery history, bilateral lymphedema or a history of transplantation were excluded
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 Decongestion TherapyIt is given in two phases. First phase includes intensive therapy which aims to reduce the volume of the extremity. Second phase aims to preserve these reductions of volume. All patients were prescribed lymphedema specific exercises and were advised to walk (for 30 minutes everyday) daywhile taking complete decongestive therapy. They were specifically informed that exercise does not aggravate the severity of their lymphedema. Short stretch bandages were applied to the patients with self manual lymphatic drainage. Intensive phase was given 5 days a week, and short stretch bandages applied for 23 hours a day with 1 hour interval. To increase the local pressure on the areas required, foams were added. Patients were screened with arm circumferential measurements once a week. After gaining a plateau in the volumes, patients were prescribed compression garments. | Other | Breast cancer related lymphedema |
Primary outcome
Hand grip strength
Time frame: 3 weeks
Hand grip strength: Hand grip strength was measured using JAMAR® hand dynamometer. It has been used to assess hand grip strength in many studies over half a century. Patients were 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 was recorded. Patients' measurements were taken for both affected and unaffected arm, and recorded as kgf.
Extremity volume
Time frame: 3 weeks
Volume measurements were 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 was calculated and recorded before and after the treatment for both arms. All patients' measurements were taken by the same researcher.
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 10 May 2019.
- Individual participant dataSharing planned: No
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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?
An observational study of Lymphedema Arm and Lymphedema; Surgical, 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 2 inclusion and 1 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 10 May 2019. 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?
Hand grip strength (time frame: 3 weeks). The study lists 2 primary outcomes in all. 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 10 May 2019.