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)

NCT07170631 | Not Yet Recruiting

• 1 other identifier: FIS-2025-07
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

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; Peripheral nerve ultrasound

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (before intervention), Immediately post-program (Day 0 after completion)

Secondary Outcomes (6)

• Change in neuropathic pain intensity measured with DN4 questionnaire

  Baseline (before intervention), Immediately post-program (Day 0 after completion)

• Change in hand grip strength from baseline measured with handheld dynamometer (kg)

  Baseline (before intervention), Immediately post-program (Day 0 after completion)

• Change in nerve cross-sectional area measured with high-resolution ultrasound (mm²)

  Baseline (before intervention), Immediately post-program (Day 0 after completion)

• Change in upper limb function measured with QuickDASH questionnaire (score 0-100)

  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)

  Baseline (before intervention), Immediately post-program (Day 0 after completion)

Study Arms (1)

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.

Other: Therapeutic exercise

Interventions

Therapeutic exercise OTHER

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.

Therapeutic exercise

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead
• Consorci Sanitari de Terrassa: collaborator

MeSH Terms

Conditions

Breast Cancer Lymphedema; Breast Neoplasms; Lymphedema; Peripheral Nervous System Diseases

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Aïda Cadellans Arróniz (Principal Investigator), PT, PhD

  Universitat Internacional de Catalunya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aïda Cadellans Arroniz (Principal Investigator), PT, PhD

CONTACT

935-04-20-00; acadellans@uic.es

Silvia Ortega Cebrian, PT, PhD

CONTACT

935 04 20 00; sortega@uic.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Associate Professor

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 12, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: IPD will be shared at the time of publication of the main results and will be available for up to 5 years.
• Access Criteria: Data will be shared with qualified researchers upon reasonable request for scientific purposes, subject to approval by the study team. A data access agreement will be required.