Breast Cancer-Related LymphedemaNCT07014657
Effect of Digital Combined Decongestive Therapy in Patients With Breast Cancer-related Lymphedema: a Follow-up Study
A study testing Digital Combined Decongestive Therapy in people with Breast Cancer-Related Lymphedema, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
This study investigated the short- and long-term effects of digital combined decongestive therapy in breast cancer-related lymphedema. Limb volume and quality of life (Lymph-ICF) were assessed at baseline, post-treatment, and 12-week follow-up. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer-Related Lymphedema
- What is being tested?
- Digital Combined Decongestive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2018to 20 Jun 2024
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed with breast cancer-related lymphedema (BCRL) within the last 6 to 60 months.
- Voluntarily agreed to participate in the study.
Who cannot join
- Presence of active infection.
- History of bilateral breast surgery.
- Severe breast cancer-related lymphedema.
Trial locations and contacts
1 site in 1 country.
About this study
This study investigated the short- and long-term effects of digital combined decongestive therapy in breast cancer-related lymphedema. Limb volume and quality of life (Lymph-ICF) were assessed at baseline, post-treatment, and 12-week follow-up.
Read the detailed description
This study evaluated the feasibility and effectiveness of a digital combined decongestive therapy (CDT) program in patients with breast cancer-related lymphedema. After an initial face-to-face training session on self-bandaging, self-manual lymphatic drainage, breathing exercises, and skin care, patients followed a 4-week digital CDT program with remote guidance. Compression garments were used during the maintenance phase. Limb volume was measured using circumference method. Quality of life was assessed with the Lymph-ICF questionnaire. Assessments were repeated post-treatment and at 12-week follow-up.
- Conditions
- Breast Cancer-Related Lymphedema
- Being tested
- Digital Combined Decongestive Therapy
- Keywords
- Breast cancer-related lymphedema, Combined decongestive therapy, Digital therapy
- 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.
Digital Combined Decongestive TherapyBehavioural
Participants received digital combined decongestive therapy, which included an initial face-to-face session where skin care and risk reduction training were provided. Self-bandaging and self-manual lymphatic drainage techniques were demonstrated and practiced under supervision. Additionally, decongestive and breathing exercises were taught to both patients and caregivers. Following this, the intensive treatment phase was conducted remotely using electronic communication technologies over a period of 4 weeks to monitor and guide the therapy. After the intensive phase, participants continued with maintenance therapy, which involved the use of compression stockings. The therapy aimed to reduce limb volume and improve symptoms related to breast cancer-related lymphedema.
| Study group | Role | What they receive |
|---|---|---|
| Digital Combined Decongestive Therapy Group | Experimental | Participants received digital combined decongestive therapy including self-bandaging, self-manual lymphatic drainage, decongestive and breathing exercises, supervised remotely through telecommunication technologies for 4 weeks, followed by maintenance therapy with compression stockings. Receives: Behavioral: Digital Combined Decongestive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Limb Volume
Limb volume was assessed by measuring the circumference of the affected arm at 4-cm intervals from the ulnar styloid to the axillary region using a standard tape measure. These measurements were used to calculate the total limb volume to evaluate changes after the intervention and at follow-up.
Measured: At baseline, at week 4 (end of treatment), and at week 12 (follow-up)
Secondary outcomes (1)
Change in Quality of Life
Quality of life was assessed using the Turkish validated and reliable lymphedema-specific questionnaire, Lymph-ICF. The questionnaire consists of 29 items including 7 questions about arm symptoms and 22 questions related to functional impairments in daily activities. It covers five subscales: physical function, mental status, household activities, mobility activities, and social life. Patients rated their complaints on a 0 to 100 mm visual analog scale (VAS), where 0 indicates no complaints and 100 indicates the worst complaints. Higher scores represent worse quality of life.
Measured: At baseline, at week 4 (end of treatment), and at week 12 (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start10 Jan 2018
- Primary completion5 Jan 2024
- Study completion20 Jun 2024
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 Breast Cancer-Related LymphedemaStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selva Otsay, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014657
- Sponsor's protocol ID
- Lenfödemüst2025
- Status last verified
- Jan 2018
- First submitted
- 3 Jun 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Borman P, Yaman A, Yasrebi S, Pinar Inanli A, Arikan Donmez A. Combined Complete Decongestive Therapy Reduces Volume and Improves Quality of Life and Functional Status in Patients With Breast Cancer-Related Lymphedema. Clin Breast Cancer. 2022 Apr;22(3):e270-e277. doi: 10.1016/j.clbc.2021.08.005. Epub 2021 Aug 19.
PubMed 34535391
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Digital Combined Decongestive Therapy in Patients With Breast Cancer-related Lymphedema: a Follow-up Study
- ClinicalTrials.gov ID
- NCT07014657
- Acronym / sponsor ID
- Lenfödemüst2025
- Conditions
- Breast Cancer-Related Lymphedema
- Keywords
- Breast cancer-related lymphedema, Combined decongestive therapy, Digital therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 11 Jun 2025 (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 investigated the short- and long-term effects of digital combined decongestive therapy in breast cancer-related lymphedema. Limb volume and quality of life (Lymph-ICF) were assessed at baseline, post-treatment, and 12-week follow-up.
Detailed description
This study evaluated the feasibility and effectiveness of a digital combined decongestive therapy (CDT) program in patients with breast cancer-related lymphedema. After an initial face-to-face training session on self-bandaging, self-manual lymphatic drainage, breathing exercises, and skin care, patients followed a 4-week digital CDT program with remote guidance. Compression garments were used during the maintenance phase. Limb volume was measured using circumference method. Quality of life was assessed with the Lymph-ICF questionnaire. Assessments were repeated post-treatment and at 12-week follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital Combined Decongestive Therapy Group | Experimental | Behavioral: Digital Combined Decongestive TherapyParticipants received digital combined decongestive therapy including self-bandaging, self-manual lymphatic drainage, decongestive and breathing exercises, supervised remotely through telecommunication technologies for 4 weeks, followed by maintenance therapy with compression stockings. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with breast cancer-related lymphedema (BCRL) within the last 6 to 60 months.
- Voluntarily agreed to participate in the study.
Key exclusion criteria (3 listed)
- Presence of active infection.
- History of bilateral breast surgery.
- Severe breast cancer-related lymphedema.
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 |
|---|---|---|
| Digital Combined Decongestive TherapyParticipants received digital combined decongestive therapy, which included an initial face-to-face session where skin care and risk reduction training were provided. Self-bandaging and self-manual lymphatic drainage techniques were demonstrated and practiced under supervision. Additionally, decongestive and breathing exercises were taught to both patients and caregivers. Following this, the intensive treatment phase was conducted remotely using electronic communication technologies over a period of 4 weeks to monitor and guide the therapy. After the intensive phase, participants continued with maintenance therapy, which involved the use of compression stockings. The therapy aimed to reduce limb volume and improve symptoms related to breast cancer-related lymphedema. | Behavioural | Digital Combined Decongestive Therapy Group |
Primary outcome
Change in Limb Volume
Time frame: At baseline, at week 4 (end of treatment), and at week 12 (follow-up)
Limb volume was assessed by measuring the circumference of the affected arm at 4-cm intervals from the ulnar styloid to the axillary region using a standard tape measure. These measurements were used to calculate the total limb volume to evaluate changes after the intervention and at follow-up.
1 secondary outcome
Change in Quality of Life
Time frame: At baseline, at week 4 (end of treatment), and at week 12 (follow-up)
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 11 Jun 2025.
- Background: PubMed 34535391Borman P, Yaman A, Yasrebi S, Pinar Inanli A, Arikan Donmez A. Combined Complete Decongestive Therapy Reduces Volume and Improves Quality of Life and Functional Status in Patients With Breast Cancer-Related Lymphedema. Clin Breast Cancer. 2022 Apr;22(3):e270-e277. doi: 10.1016/j.clbc.2021.08.005. Epub 2021 Aug 19.
- 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?
A study testing Digital Combined Decongestive Therapy in people with Breast Cancer-Related Lymphedema, run by Bezmialem Vakif 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 3 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 11 Jun 2025. 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?
Change in Limb Volume (time frame: At baseline, at week 4 (end of treatment), and at week 12 (follow-up)). 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 NCT07014657, 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 11 Jun 2025.