Prehabilitation of Breast Cancer-Related Lymphedema

NCT07301580 | Completed

• 1 other identifier: UHSBalikesirRadiationOnc
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer-Related Arm Lymphedema; Prehabilitation; Quality of Life Impairment; Fatigue Syndrome, Chronic

Keywords

Breast cancer-related lymphedema; prehabilitation; pre-irradiation; pre-surgery

Outcome Measures

Primary Outcomes (3)

• Incidence of Lymphedema Development

  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.

  Baseline; 1, 3, 6, and 12 months postoperatively

• Pain Intensity

  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.

  Baseline; 1, 3, 6, and 12 months postoperatively

• Quality of Life Impairment

  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.

  Baseline; 3, 6, and 12 months postoperatively

Secondary Outcomes (2)

• Upper Extremity Function

  Baseline; 1, 3, 6, and 12 months postoperatively

• Exercise Adherence

  Throughout the 12-month follow-up

Study Arms (1)

Prehabilitation Exercise Group

OTHER

Behavioral Intervention

Behavioral: Prehabilitation Exercise Group

Interventions

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.

Prehabilitation Exercise Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: female breast cancer survivors
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Health Sciences Balikesir Hospital Eduation and Research: lead

Study Sites (1)

UHS Balikesir Ataturk Health and Application Center

Balıkesir, Turkey (Türkiye)

Location

Related Publications (2)

• Toohey K, Hunter M, McKinnon K, Casey T, Turner M, Taylor S, Paterson C. A systematic review of multimodal prehabilitation in breast cancer. Breast Cancer Res Treat. 2023 Jan;197(1):1-37. doi: 10.1007/s10549-022-06759-1. Epub 2022 Oct 21.

  PMID: 36269525 RESULT

• Del Bianco N, Borsati A, Toniolo L, Ciurnielli C, Belluomini L, Insolda J, Sposito M, Milella M, Schena F, Pilotto S, Avancini A. What is the role of physical exercise in the era of cancer prehabilitation? A systematic review. Crit Rev Oncol Hematol. 2024 Jun;198:104350. doi: 10.1016/j.critrevonc.2024.104350. Epub 2024 Apr 18.

  PMID: 38642726 RESULT

MeSH Terms

Conditions

Breast Cancer Lymphedema; Fatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 24, 2025
• Study Start: October 1, 2024
• Primary Completion: October 5, 2025
• Study Completion: October 5, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-10

Locations

TU (1)