Lymphedema ArmLYNMANCT07170631
Effectiveness of a Therapeutic Exercise Program With Specific Upper Limb Exercises to Reduce Lymphedema and Neuropathy in Breast Cancer Patients: A Pre-post Study (LYNMA)
A study testing Therapeutic exercise in people with Lymphedema Arm and Lymphedema Due to Radiation, run by Universitat Internacional de Catalunya.
Trial summary
This study aims to evaluate the effectiveness of a therapeutic exercise program designed specifically for women with breast cancer. The program includes general exercises along with specific movements for the upper limb to help reduce common side effects of cancer treatment such as lymphedema (swelling of the arm) and… Read more about this study
- Who is it for?
- Ages 35 to 70 years, women only
- Conditions the study is for
- Lymphedema Arm, Lymphedema Due to Radiation, Lymphedema, Breast Cancer
- What is being tested?
- Therapeutic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients receiving treatment for breast carcinoma.reatments include surgical procedures (breast-conserving surgery or mastectomy), axillary lymph node dissection, sentinel lymph node biopsy, radiotherapy, chemotherapy, and hormone therapy.
- Participants must provide authorization from their primary care physician and/or oncologist to perform therapeutic exercise.
- Diagnosis of lymphedema associated with stage I or II breast cancer (Stage 1 or mild: circumference difference less than 4 cm [volume difference 10-25%] compared to the healthy arm; Stage 2 or moderate: circumference difference between 4 and 6 cm [volume difference 25-50%] compared to the healthy arm).
- A score of 4 or higher on the DN4 questionnaire (neuropathic pain)
Who cannot join
- Lack of medical authorization.
- Pre-existing cardiac pathology prior to cancer diagnosis.
- Exacerbation of comorbidities.
- Travel time exceeding 45 minutes to the location where the therapeutic exercise program is conducted.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of a General Therapeutic Exercise Program Including Specific Upper Limb Exercises to Reduce Lymphedema and Peripheral Neuropathy Secondary to Oncological Treatment in Patients With Breast Cancer: A Pre-post Intervention Study (LYNMA)
This study aims to evaluate the effectiveness of a therapeutic exercise program designed specifically for women with breast cancer. The program includes general exercises along with specific movements for the upper limb to help reduce common side effects of cancer treatment such as lymphedema (swelling of the arm) and neuropathy (nerve pain or numbness). Participants will undergo the exercise program and be assessed before and after to determine improvements in their symptoms and overall quality of life. The goal is to provide evidence that targeted physical therapy can improve recovery and well-being in breast cancer survivors.
Read the detailed description
This pre-post intervention study aims to assess the effectiveness of a comprehensive therapeutic exercise program tailored for breast cancer patients experiencing lymphedema and neuropathy secondary to cancer treatment. The program combines general physical exercises with specific upper limb movements targeting symptom reduction and functional improvement. Participants will be evaluated before and after the intervention to measure changes in arm swelling, nerve symptoms, physical function, and quality of life. The study will contribute valuable data on non-pharmacological rehabilitation strategies that could enhance recovery and reduce long-term complications in breast cancer survivors.
- Conditions
- Lymphedema Arm, Lymphedema Due to Radiation, Lymphedema, Breast Cancer, Peripheral Neuropathy Due to Chemotherapy, Peripheral Neuropathy in Breast Cancer Patient
- Being tested
- Therapeutic exercise
- Keywords
- Therapeutic exercise, Breast cancer, Lymphedema, Peripheral neuropathy, Upper limb exercises, Oncology physiotherapy, Neural mobilization, Neurodynamic techniques, Peripheral nerve ultrasound
- Medical subject headings
- Breast Cancer Lymphedema, Breast Neoplasms, Lymphedema, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic exerciseOther
Participants will follow a 3-month therapeutic exercise program combining general exercises with specific upper limb exercises, including hand proprioception and neurodynamic techniques. Two group sessions per week (1 to 1.15 hours each) will be conducted, with at least 24 hours between sessions. Each session includes warm-up, three progressive work blocks with strength, mobility, and balance exercises, and a cool-down. Strength training uses body weight and equipment, with intensity guided by the Rate of Perceived Exertion (RPE) scale, progressing safely from moderate to higher levels. Mobility and balance exercises target trunk, upper and lower limbs, and postural control. Neurodynamic techniques focus on median, radial, and ulnar nerves using neural sliding and intermittent tension, stopping exercises if pain exceeds 4/10. Supervised by experienced physiotherapists, the program aims to reduce lymphedema and neuropathy symptoms in breast cancer patients undergoing cancer treatment.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic exercise | Experimental | Participants will undergo a general therapeutic exercise program including specific upper limb exercises designed to reduce lymphedema and neuropathy secondary to cancer treatment. The program consists of supervised sessions two times per week over 12 weeks, led by a specialized physiotherapist. Exercises include mobility, strength, and neurodynamic techniques. Receives: Other: Therapeutic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excess limb volume (%) compared to the unaffected limb
Excess volume of the affected limb (percentage compared to the unaffected limb). The volume of each limb will be measured manually using a measuring tape by taking circumferences every 4 centimeters from the wrist to the axilla. Limb volume will be calculated using the Kuhnke formula: Volume equals the sum of the squares of the circumferences (C1 squared plus C2 squared plus ... plus Cn squared) divided by pi, where C1, C2, … Cn are the circumferences measured at different points along the limb.
Measured: Baseline (before intervention), Immediately post-program (Day 0 after completion)
Secondary outcomes (6)
Change in neuropathic pain intensity measured with DN4 questionnaire
Will be assessed using the DN4 questionnaire, designed to help identify neuropathic pain. It is a simple, quick, and highly reliable tool widely used in clinical practice and research. The questionnaire consists of 10 items divided into two parts: a patient interview and a physical examination performed by the healthcare professional. Each item is scored as "yes" or "no," with each positive answer receiving 1 point. A total score of 4 or more is interpreted as indicative of neuropathic pain
Measured: Baseline (before intervention), Immediately post-program (Day 0 after completion)
Change in hand grip strength from baseline measured with handheld dynamometer (kg)
Hand grip strength will be assessed using a digital hand dynamometer (BIMS). This test is an indicator of overall muscle strength and has been previously used as a marker of clinical and nutritional status, as well as a predictor of decreased functional capacity in breast cancer patients
Measured: Baseline (before intervention), Immediately post-program (Day 0 after completion)
Change in nerve cross-sectional area measured with high-resolution ultrasound (mm²)
Will be assessed using musculoskeletal ultrasound, a useful technique to evaluate possible signs of inflammation, entrapment, or neuropathy. Observed changes can provide relevant information about the presence of inflammation or compression. One common indicator is an increased cross-sectional area of the nerve (measured in mm), which may indicate intraneural edema or an inflammatory process. We will complement the assessment by comparing the affected nerve with the contralateral healthy side to detect differences that may be considered pathological.
Measured: Baseline (before intervention), Immediately post-program (Day 0 after completion)
Change in upper limb function measured with QuickDASH questionnaire (score 0-100)
Upper limb function will be measured with the DASH (Disabilities of the Arm, Shoulder, and Hand) questionnaire. This tool assesses the function of the arm, shoulder, and hand in patients with disorders or injuries in these areas. Responses are scored on a scale from 0 to 4, where 0 means no difficulty or pain, and 4 indicates severe difficulty or unbearable pain. The total score is calculated by summing responses and normalizing to a 0-100 scale, where 0 indicates no disability (perfect function) and 100 indicates maximum disability or total loss of function.
Measured: Baseline (before intervention), Immediately post-program (Day 0 after completion)
Change in range of motion of shoulder rotations, elbow and wrist flexion-extension measured with goniometer (degrees)
Range of motion (shoulder rotations, elbow and wrist flexion-extension) will be measured using a manual goniometer, a clinical, physiotherapeutic, and biomechanical tool used to assess joint angles. Shoulder rotation movements will be evaluated, as well as flexion and extension for the elbow and wrist.
Measured: Baseline (before intervention), Immediately post-program (Day 0 after completion)
Change in quality of life from baseline measured with EORTC QLQ-C30 questionnaire (score 0-100)
Quality of life will be assessed with the EORTC Breast Cancer-Specific Questionnaire (QLQ-BR23), a specific version of the EORTC QLQ-C30 designed to evaluate quality of life in women diagnosed with breast cancer. This questionnaire complements the EORTC QLQ-C30 by adding questions focused on symptoms and concerns specific to breast cancer patients, as well as side effects related to treatments. Each item is scored on a scale from 0 to 4, where a higher score indicates better quality of life.
Measured: Baseline (before intervention), Immediately post-program (Day 0 after completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study startJan 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionOct 2026 (estimated)
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.
- 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Collaborators
- Consorci Sanitari de Terrassa
- Responsible party
- Principal investigator, Aïda Cadellans-Arróniz, Universitat Internacional de Catalunya
- Investigators
- Aïda Cadellans Arróniz (Principal Investigator), PT, PhD, Principal investigator, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07170631
- Sponsor's protocol ID
- FIS-2025-07
- Acronym
- LYNMA
- Status last verified
- Sep 2025
- First submitted
- 5 Sep 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified individual participant data (IPD) will be made available to qualified researchers upon reasonable request, following publication of the primary results. Data will be shared via institutional repository or secure data-sharing platform.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a General Therapeutic Exercise Program Including Specific Upper Limb Exercises to Reduce Lymphedema and Peripheral Neuropathy Secondary to Oncological Treatment in Patients With Breast Cancer: A Pre-post Intervention Study (LYNMA)
- ClinicalTrials.gov ID
- NCT07170631
- Acronym / sponsor ID
- LYNMA / FIS-2025-07
- Conditions
- Lymphedema Arm, Lymphedema Due to Radiation, Lymphedema, Breast Cancer, Peripheral Neuropathy Due to Chemotherapy, Peripheral Neuropathy in Breast Cancer Patient
- Keywords
- Therapeutic exercise, Breast cancer, Lymphedema, Peripheral neuropathy, Upper limb exercises, Oncology physiotherapy, Neural mobilization, Neurodynamic techniques
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Collaborators
- Consorci Sanitari de Terrassa
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 12 Sep 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 aims to evaluate the effectiveness of a therapeutic exercise program designed specifically for women with breast cancer. The program includes general exercises along with specific movements for the upper limb to help reduce common side effects of cancer treatment such as lymphedema (swelling of the arm) and neuropathy (nerve pain or numbness). Participants will undergo the exercise program and be assessed before and after to determine improvements in their symptoms and overall quality of life. The goal is to provide evidence that targeted physical therapy can improve recovery and well-being in breast cancer survivors.
Detailed description
This pre-post intervention study aims to assess the effectiveness of a comprehensive therapeutic exercise program tailored for breast cancer patients experiencing lymphedema and neuropathy secondary to cancer treatment. The program combines general physical exercises with specific upper limb movements targeting symptom reduction and functional improvement. Participants will be evaluated before and after the intervention to measure changes in arm swelling, nerve symptoms, physical function, and quality of life. The study will contribute valuable data on non-pharmacological rehabilitation strategies that could enhance recovery and reduce long-term complications in breast cancer survivors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Therapeutic exercise | Experimental | Other: Therapeutic exerciseParticipants will undergo a general therapeutic exercise program including specific upper limb exercises designed to reduce lymphedema and neuropathy secondary to cancer treatment. The program consists of supervised sessions two times per week over 12 weeks, led by a specialized physiotherapist. Exercises include mobility, strength, and neurodynamic techniques. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients receiving treatment for breast carcinoma.reatments include surgical procedures (breast-conserving surgery or mastectomy), axillary lymph node dissection, sentinel lymph node biopsy, radiotherapy, chemotherapy, and hormone therapy.
- Participants must provide authorization from their primary care physician and/or oncologist to perform therapeutic exercise.
- Diagnosis of lymphedema associated with stage I or II breast cancer (Stage 1 or mild: circumference difference less than 4 cm [volume difference 10-25%] compared to the healthy arm; Stage 2 or moderate: circumference difference between 4 and 6 cm [volume difference 25-50%] compared to the healthy arm).
- A score of 4 or higher on the DN4 questionnaire (neuropathic pain)
Key exclusion criteria (4 listed)
- Lack of medical authorization.
- Pre-existing cardiac pathology prior to cancer diagnosis.
- Exacerbation of comorbidities.
- Travel time exceeding 45 minutes to the location where the therapeutic exercise program is conducted.
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 |
|---|---|---|
| Therapeutic exerciseParticipants will follow a 3-month therapeutic exercise program combining general exercises with specific upper limb exercises, including hand proprioception and neurodynamic techniques. Two group sessions per week (1 to 1.15 hours each) will be conducted, with at least 24 hours between sessions. Each session includes warm-up, three progressive work blocks with strength, mobility, and balance exercises, and a cool-down. Strength training uses body weight and equipment, with intensity guided by the Rate of Perceived Exertion (RPE) scale, progressing safely from moderate to higher levels. Mobility and balance exercises target trunk, upper and lower limbs, and postural control. Neurodynamic techniques focus on median, radial, and ulnar nerves using neural sliding and intermittent tension, stopping exercises if pain exceeds 4/10. Supervised by experienced physiotherapists, the program aims to reduce lymphedema and neuropathy symptoms in breast cancer patients undergoing cancer treatment. | Other | Therapeutic exercise |
Primary outcome
Excess limb volume (%) compared to the unaffected limb
Time frame: Baseline (before intervention), Immediately post-program (Day 0 after completion)
Excess volume of the affected limb (percentage compared to the unaffected limb). The volume of each limb will be measured manually using a measuring tape by taking circumferences every 4 centimeters from the wrist to the axilla. Limb volume will be calculated using the Kuhnke formula: Volume equals the sum of the squares of the circumferences (C1 squared plus C2 squared plus ... plus Cn squared) divided by pi, where C1, C2, … Cn are the circumferences measured at different points along the limb.
6 secondary outcomes
Change in neuropathic pain intensity measured with DN4 questionnaire
Time frame: Baseline (before intervention), Immediately post-program (Day 0 after completion)
Change in hand grip strength from baseline measured with handheld dynamometer (kg)
Time frame: Baseline (before intervention), Immediately post-program (Day 0 after completion)
Change in nerve cross-sectional area measured with high-resolution ultrasound (mm²)
Time frame: Baseline (before intervention), Immediately post-program (Day 0 after completion)
Change in upper limb function measured with QuickDASH questionnaire (score 0-100)
Time frame: Baseline (before intervention), Immediately post-program (Day 0 after completion)
Change in range of motion of shoulder rotations, elbow and wrist flexion-extension measured with goniometer (degrees)
Time frame: Baseline (before intervention), Immediately post-program (Day 0 after completion)
Change in quality of life from baseline measured with EORTC QLQ-C30 questionnaire (score 0-100)
Time frame: Baseline (before intervention), Immediately post-program (Day 0 after completion)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: Yes. The de-identified individual participant data (IPD) will be made available to qualified researchers upon reasonable request, following publication of the primary results. Data will be shared via institutional repository or secure data-sharing platform.
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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.
Aïda Cadellans Arróniz (Principal Investigator), PT, PhD principal investigator
Universitat Internacional de Catalunya
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic exercise in people with Lymphedema Arm and Lymphedema Due to Radiation, run by Universitat Internacional de Catalunya.
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 4 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: opening soon, as of the sponsor's last update on 18 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aïda Cadellans Arroniz (Principal Investigator), PT, PhD (935-04-20-00, acadellans@uic.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Excess limb volume (%) compared to the unaffected limb (time frame: Baseline (before intervention), Immediately post-program (Day 0 after completion)). 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 18 Sep 2025.