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NCT Number: NCT07301580

Prehabilitation of Breast Cancer-Related Lymphedema

This prospective prehabilitation study aims to evaluate the effects of an individualized exercise program initiated before breast cancer surgery and continued for 12 months postoperatively. The intervention focuses on incidence of breast cancer-related lymphedema, improving functional outcomes, range of motion, pain, and patient-reported measures throughout the surgical and recovery phases. Participants receive structured, personalized exercise instructions and are monitored regularly during follow-up.

The study assesses the trajectory of extremity volume difference, early postoperative pain, the recovery pattern of shoulder range of motion and changes in functional status across the first postoperative year. Additionally, it examines the incidence of lymphedema and explores demographic and clinical determinants affecting patient outcomes. The findings are expected to provide evidence for the integration of prehabilitation into standard breast cancer care pathways.

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Key information

Conditions

Breast Cancer-Related Arm Lymphedema Breast Cancer Lymphedema Chronic Disease Disease Attributes Encephalomyelitis Fatigue Syndrome, Chronic Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Prehabilitation Quality of Life Impairment

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UHS Balikesir Ataturk Health and Application Center

Balıkesir, Turkey (Türkiye)

About this study

This prospective prehabilitation study investigates the effectiveness of an individualized exercise program initiated before breast cancer surgery and radiation therapy maintained for 12 months postoperatively. The intervention was designed to optimize physical readiness for surgery, support early postoperative recovery, and promote long-term functional improvement. Participants received structured exercise instructions delivered through visual and written materials, and adherence was reinforced through regular follow-up contacts.

The primary focus of the study is to characterize postoperative functional trajectories, including pain intensity, shoulder range of motion (ROM), upper-extremity function, and patient-reported outcomes. Particular emphasis is placed on the early postoperative period, during which pain typically increases and functional limitations become more pronounced. Longitudinal assessments allow observation of recovery patterns across all ROM planes, with anticipated improvements in flexion and abduction by the third postoperative month and further recovery in internal and external rotation by the sixth month.

A secondary objective is to monitor the development of lymphedema, defined by limb volume differences and physical signs of edema. The study also explores demographic and clinical determinants that may influence treatment outcomes, aiming to identify subgroups that benefit most from prehabilitation. By evaluating functional, symptomatic, and quality-of-life outcomes across a 12-month period, this study provides evidence to support the incorporation of preoperative exercise interventions into standard breast cancer care pathways.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women aged 18 years or older
  • Diagnosed with breast cancer and scheduled for surgical treatment
  • Able to perform prescribed upper-extremity exercises
  • Able to provide informed consent and complete follow-up assessments.

Exclusion criteria

  • Presence of metastatic disease at baseline
  • Neurological, orthopedic, or systemic conditions limiting upper-extremity mobility
  • Prior breast or axillary surgery on the same side
  • Planned neoadjuvant chemotherapy that would delay the initiation of the exercise program
  • Inability to comply with the exercise instruction or follow-up schedule

Treatment and study plan

Prehabilitation Exercise Group

Behavioral

A personalized upper-extremity exercise program initiated before surgery and continued for 12 months postoperatively. The program includes mobility, stretching, strengthening, and functional exercises tailored to individual needs. Instruction is provided through written and visual materials, with follow-up contacts to reinforce adherence.

Primary outcomes

  1. Incidence of Lymphedema Development

    Time frame: Baseline; 1, 3, 6, and 12 months postoperatively

    Lymphedema is determined by volume differences between extremities and physical signs of edema.

    Physical examination consists of inspection of the patient for swelling, rash, dermal ulcerations, hyperkeratosis, vascular signs continuing with palpation for pitting and Stemmer's sign. Limb circumferences were measured using a constant-tension tape beginning from the ulnar styloid process in the upper extremity with 4 cm intervals up to 32 cm. Afterwards limb volume was estimated via calculator model.

    Calculation results are compared by opposite limb and volume difference of 200 ml or 5-10% is considered as Lymphedema. Clinical severity was graded according to the International Society of Lymphology (ISL) staging system (Stages 0-III), based on presence of swelling, reversibility, pitting, and tissue fibrosis.

  2. Pain Intensity

    Time frame: Baseline; 1, 3, 6, and 12 months postoperatively

    The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). It is performed by asking the patient to rate their current level of pain by placing a mark on the line.

  3. Quality of Life Impairment

    Time frame: Baseline; 3, 6, and 12 months postoperatively

    Quality of life is assessed with standardized patient-reported questionnaires. The EORTC Core Quality of Life(QoL) questionnaire (EORTC QLQ-C30) is designed to measure cancer patients' physical, psychological and social functions. The questionnaire is composed of multi-item scales and single items.

    EORTC-QLQ-C30 gives information about how affected the patients are about physical, emotional, social and financial aspects because of the disease and treatments. Form includes twenty-eight questions answered as from one to four Likert scale, reflecting grades of agree to disagree respectively. Final two questions necessitate giving value on a seven point scale, to the quality of life and global health of the last week. Global health score and physical functioning score reflects better QoL in higher values while symptom scale results worser in high values.

Secondary outcomes

  1. Upper Extremity Function

    Time frame: Baseline; 1, 3, 6, and 12 months postoperatively

    Upper extremity functional index-15 (UEFI-15) iss used to assess the functional status of the upper extremity by 15-items based on activities of daily living. Sum of the item scores are converted to final score between 0-100 points means the higher score is better functional capacity.

  2. Exercise Adherence

    Time frame: Throughout the 12-month follow-up

    Compliance with the prescribed home-based exercise program is questioned if they are performing the exercises properly according to the template they are given at every visit with physician and overlooked if patient requires. Percentage of patients performing regular exercise will be interpreted after 12-months follow-up.

Sponsors and collaborators

Lead sponsor

University of Health Sciences Balikesir Hospital Eduation and Research

Other Gov

Registry information

Official study title

Physical Prehabilitation of Breast Cancer-Related Lymphedema

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 24, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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