Breast Cancer Related LymphedemaNCT06065423
Evaluation of Home Program and Telerehabilitation for the Treatment Process in Patients With Breast Cancer-Related Lymphedema
A study testing Manuel Lymphatic Drainage(MLD), Exercises in people with Breast Cancer Related Lymphedema and Telerehabilitation, run by Marmara University at 2 sites in Turkey (Türkiye).
Trial summary
During the Covid-19 pandemic, rehabilitation services for all patients were affected, and a term that was previously in use but gained popularity during the pandemic entered our vocabulary: 'Telerehabilitation'. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Related Lymphedema, Telerehabilitation
- What is being tested?
- Manuel Lymphatic Drainage(MLD), Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 1 Jun 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 18 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who had undergone breast surgery at least 3 months ago
- Had stage 1-2 lymphedema
- Had upper extremity lymphedema associated with breast cancer
Who cannot join
- Signs of infection such as lymphangitis, cellulitis, fungal infections
- Those with documented lymph node metastases
- Those with bilateral lymphedema
- Those with other diseases affecting upper extremity functions
- Those with a history of previous surgery related to the upper extremity
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Canan Şanal-Toprak
Istanbul, 34899
Marmara University School of Medicine, Pendik Education and Research Hospital, Department of Physical Medicine and Rehabilitation
Istanbul
About this study
During the Covid-19 pandemic, rehabilitation services for all patients were affected, and a term that was previously in use but gained popularity during the pandemic entered our vocabulary: 'Telerehabilitation'. The purpose of our study is to evaluate the treatment process and adherence of patients undergoing telerehabilitation.
Read the detailed description
Our study is a randomized single-blind prospective study. Patients aged 18 to 75 years with stage 1-2 lymphedema associated with breast cancer and upper extremity lymphedema, who had undergone breast surgery at least 3 months prior, were included in the study. Group 1: Patients were given a brochure explaining the massage and exercises they should perform. They were periodically contacted by a physiotherapist and clinician to remind them of their tasks. Group 2: Patients underwent telerehabilitation exercises and massages three times a week guided by a physiotherapist and clinician, and on the remaining days, they continued their self-administered tasks. Patients were evaluated three times: before treatment, at weeks 5 and 8 after treatment. During each visit, patients' inter-limb volume difference, Quick DASH and Life Impact Scale scores, pain, tension, stiffness, and heaviness sensations were assessed.
- Being tested
- Manuel Lymphatic Drainage(MLD), Exercises
- Medical subject headings
- Breast Cancer Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manuel Lymphatic Drainage(MLD), ExercisesOther
MLD:It is a unique massage technique that uses specific hand movements to provide a gentle pumping effect on the skin.
Massage movements follow the direction of lymph flow and produce rapid results. The aim of this method is to achieve maximum skin tightening effect with minimum pressure.
Exercise, on the other hand, increases physical performance, improves body composition, and provides an increase in quality of life by providing acute and chronic reductions in fatigue. Both aerobic exercises and strengthening exercises have been found effective on physical performance. It shows that a mixed program consisting of components such as aerobics, strengthening, coordination and stretching can positively affect flexibility, pain and energy expenditure in breast cancer patients.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation Group | Experimental | patients received exercises and massages through TR three times a week, conducted by a physiotherapist and a clinician. They were encouraged to perform their exercises and wear compression garments on the remaining days. Prior to the program, patients or their relatives received training from physiotherapists regarding exercises and Manual Lymphatic Drainage (MLD). Patients or their relatives were informed about the Zoom program and were instructed to acquire the application online. Two physiotherapists and groups of five patients each were organized based on rehabilitation days and hours, and access to the Zoom link was provided. Receives: Other: Manuel Lymphatic Drainage(MLD), Exercises |
| Home- Exercise Group | Active comparator | patients were provided with a brochure explaining the massages and exercises they needed to perform. Additionally, they were contacted three times a week by a physiotherapist and a clinician to remind them of the treatments, assess the continuity and accuracy of the treatments, encourage them to perform the treatments correctly and consistently, and promote the wearing of compression garments. Receives: Other: Manuel Lymphatic Drainage(MLD), Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume Measurements
Arm measurement was measured with a tape measure at 4 cm intervals and calculated using the cone method in cm3
Measured: Time Frame: Day 0
Volume Measurements
Arm measurement was measured with a tape measure at 4 cm intervals and calculated using the cone method in cm3
Measured: Time Frame: 5 weeks
Volume Measurements
Arm measurement was measured with a tape measure at 4 cm intervals and calculated using the cone method in cm3
Measured: Time Frame: 8 weeks
Symptom Severity
Shoulder pain, tightness, sensation of heaviness, and stiffness were evaluated using a numerical scale (1 to 10 points)
Measured: Time Frame: Day 0
Symptom Severity
Shoulder pain, tightness, sensation of heaviness, and stiffness were evaluated using a numerical scale (1 to 10 points)
Measured: Time Frame: 5 weeks
Symptom Severity
Shoulder pain, tightness, sensation of heaviness, and stiffness were evaluated using a numerical scale (1 to 10 points)
Measured: Time Frame: 8 weeks
Functionality
Ouick Disabilities of the Arm, Shoulder and Hand (Quick DASH) questionnaire
Measured: Time Frame: Day 0
Functionality
Ouick Disabilities of the Arm, Shoulder and Hand (Quick DASH) questionnaire
Measured: Time Frame: 5 weeks
Functionality
Ouick Disabilities of the Arm, Shoulder and Hand (Quick DASH) questionnaire
Measured: Time Frame: 8 weeks
Efficacity
Lymphedema Quality of Life Impact Scale
Measured: Time Frame: Day 0
Efficacity
Lymphedema Quality of Life Impact Scale
Measured: Time Frame: 5 weeks
Efficacity
Lymphedema Quality of Life Impact Scale
Measured: Time Frame: 8 weeks
Secondary outcomes (4)
Patient satisfaction with the treatment
Responses were gathered on a scale of very satisfied - satisfied - somewhat satisfied - unsatisfied
Measured: Time Frame: 5 weeks
Patient satisfaction with the treatment
Responses were gathered on a scale of very satisfied - satisfied - somewhat satisfied - unsatisfied
Measured: Time Frame: 8 weeks
patients were asked to compare their hand functionality to before the injury
Responses were gathered on a scale of 'much better - somewhat better - same - somewhat worse - much worse
Measured: Time Frame: 5 weeks
patients were asked to compare their hand functionality to before the injury
Responses were gathered on a scale of 'much better - somewhat better - same - somewhat worse - much worse
Measured: Time Frame: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start1 Sep 2021
- Primary completion1 Sep 2022
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Related LymphedemaStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CANAN ŞANAL TOPRAK, Study director, Marmara University School of Medicine, Pendik Education and Research Hospital, Department of Physical Medicine and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065423
- Sponsor's protocol ID
- 09.2021.131
- Status last verified
- Sep 2023
- First submitted
- 26 Sep 2023
- Last updated
- 3 Oct 2023
- 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 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Home Program and Telerehabilitation for the Treatment Process in Patients With Breast Cancer-Related Lymphedema
- ClinicalTrials.gov ID
- NCT06065423
- Acronym / sponsor ID
- 09.2021.131
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 3 Oct 2023 (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.
During the Covid-19 pandemic, rehabilitation services for all patients were affected, and a term that was previously in use but gained popularity during the pandemic entered our vocabulary: 'Telerehabilitation'. The purpose of our study is to evaluate the treatment process and adherence of patients undergoing telerehabilitation.
Detailed description
Our study is a randomized single-blind prospective study. Patients aged 18 to 75 years with stage 1-2 lymphedema associated with breast cancer and upper extremity lymphedema, who had undergone breast surgery at least 3 months prior, were included in the study. Group 1: Patients were given a brochure explaining the massage and exercises they should perform. They were periodically contacted by a physiotherapist and clinician to remind them of their tasks. Group 2: Patients underwent telerehabilitation exercises and massages three times a week guided by a physiotherapist and clinician, and on the remaining days, they continued their self-administered tasks. Patients were evaluated three times: before treatment, at weeks 5 and 8 after treatment. During each visit, patients' inter-limb volume difference, Quick DASH and Life Impact Scale scores, pain, tension, stiffness, and heaviness sensations were assessed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation Group | Experimental | Other: Manuel Lymphatic Drainage(MLD), Exercisespatients received exercises and massages through TR three times a week, conducted by a physiotherapist and a clinician. They were encouraged to perform their exercises and wear compression garments on the remaining days. Prior to the program, patients or their relatives received training from physiotherapists regarding exercises and Manual Lymphatic Drainage (MLD). Patients or their relatives were informed about the Zoom program and were instructed to acquire the application online. Two physiotherapists and groups of five patients each were organized based on rehabilitation days and hours, and access to the Zoom link was provided. |
| Home- Exercise Group | Active comparator | Other: Manuel Lymphatic Drainage(MLD), Exercisespatients were provided with a brochure explaining the massages and exercises they needed to perform. Additionally, they were contacted three times a week by a physiotherapist and a clinician to remind them of the treatments, assess the continuity and accuracy of the treatments, encourage them to perform the treatments correctly and consistently, and promote the wearing of compression garments. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who had undergone breast surgery at least 3 months ago
- Had stage 1-2 lymphedema
- Had upper extremity lymphedema associated with breast cancer
Key exclusion criteria (5 listed)
- Signs of infection such as lymphangitis, cellulitis, fungal infections
- Those with documented lymph node metastases
- Those with bilateral lymphedema
- Those with other diseases affecting upper extremity functions
- Those with a history of previous surgery related to the upper extremity
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 |
|---|---|---|
| Manuel Lymphatic Drainage(MLD), ExercisesMLD:It is a unique massage technique that uses specific hand movements to provide a gentle pumping effect on the skin. Massage movements follow the direction of lymph flow and produce rapid results. The aim of this method is to achieve maximum skin tightening effect with minimum pressure. Exercise, on the other hand, increases physical performance, improves body composition, and provides an increase in quality of life by providing acute and chronic reductions in fatigue. Both aerobic exercises and strengthening exercises have been found effective on physical performance. It shows that a mixed program consisting of components such as aerobics, strengthening, coordination and stretching can positively affect flexibility, pain and energy expenditure in breast cancer patients. | Other | Home- Exercise Group, Telerehabilitation Group |
Primary outcome
Volume Measurements
Time frame: Time Frame: Day 0
Arm measurement was measured with a tape measure at 4 cm intervals and calculated using the cone method in cm3
Volume Measurements
Time frame: Time Frame: 5 weeks
Arm measurement was measured with a tape measure at 4 cm intervals and calculated using the cone method in cm3
Volume Measurements
Time frame: Time Frame: 8 weeks
Arm measurement was measured with a tape measure at 4 cm intervals and calculated using the cone method in cm3
Symptom Severity
Time frame: Time Frame: Day 0
Shoulder pain, tightness, sensation of heaviness, and stiffness were evaluated using a numerical scale (1 to 10 points)
Symptom Severity
Time frame: Time Frame: 5 weeks
Shoulder pain, tightness, sensation of heaviness, and stiffness were evaluated using a numerical scale (1 to 10 points)
Symptom Severity
Time frame: Time Frame: 8 weeks
Shoulder pain, tightness, sensation of heaviness, and stiffness were evaluated using a numerical scale (1 to 10 points)
Functionality
Time frame: Time Frame: Day 0
Ouick Disabilities of the Arm, Shoulder and Hand (Quick DASH) questionnaire
Functionality
Time frame: Time Frame: 5 weeks
Ouick Disabilities of the Arm, Shoulder and Hand (Quick DASH) questionnaire
Functionality
Time frame: Time Frame: 8 weeks
Ouick Disabilities of the Arm, Shoulder and Hand (Quick DASH) questionnaire
Efficacity
Time frame: Time Frame: Day 0
Lymphedema Quality of Life Impact Scale
Efficacity
Time frame: Time Frame: 5 weeks
Lymphedema Quality of Life Impact Scale
Efficacity
Time frame: Time Frame: 8 weeks
Lymphedema Quality of Life Impact Scale
4 secondary outcomes
Patient satisfaction with the treatment
Time frame: Time Frame: 5 weeks
Patient satisfaction with the treatment
Time frame: Time Frame: 8 weeks
patients were asked to compare their hand functionality to before the injury
Time frame: Time Frame: 5 weeks
patients were asked to compare their hand functionality to before the injury
Time frame: Time Frame: 8 weeks
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 3 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer Related Lymphedema
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The LYMPH Trial - Microsurgical Versus Conservative Treatment of Chronic Breast Cancer Associated Lymphedema
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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.
CANAN ŞANAL TOPRAK study director
Marmara University School of Medicine, Pendik Education and Research Hospital, Department of Physical Medicine and Rehabilitation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manuel Lymphatic Drainage(MLD), Exercises in people with Breast Cancer Related Lymphedema and Telerehabilitation, run by Marmara University at 2 sites 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 3 inclusion and 5 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 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Volume Measurements (time frame: Time Frame: Day 0). The study lists 12 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 3 Oct 2023.