Breast Cancer-Related Arm LymphedemaNCT07301580
Prehabilitation of Breast Cancer-Related Lymphedema
A study testing Prehabilitation Exercise Group in people with Breast Cancer-Related Arm Lymphedema and Quality of Life Impairment, run by University of Health Sciences Balikesir Hospital Eduation and Research at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer-Related Arm Lymphedema, Quality of Life Impairment, Fatigue Syndrome, Chronic
- What is being tested?
- Prehabilitation Exercise Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 5 Oct 2025
- Phase
- Interventional
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
UHS Balikesir Ataturk Health and Application Center
Balıkesir
About this study
Official title: Physical 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.
Read the detailed description
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.
- Conditions
- Breast Cancer-Related Arm Lymphedema, Quality of Life Impairment, Fatigue Syndrome, Chronic, Prehabilitation
- Being tested
- Prehabilitation Exercise Group
- Keywords
- Breast cancer-related lymphedema, prehabilitation, pre-irradiation, pre-surgery
- Medical subject headings
- Breast Cancer Lymphedema, Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation Exercise GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation Exercise Group | Other | Behavioral Intervention Receives: Behavioral: Prehabilitation Exercise Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline; 3, 6, and 12 months postoperatively
Secondary outcomes (2)
Upper Extremity Function
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.
Measured: Baseline; 1, 3, 6, and 12 months postoperatively
Exercise Adherence
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.
Measured: Throughout the 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start1 Oct 2024
- Primary completion5 Oct 2025
- Study completion5 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer-Related Arm LymphedemaStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Balikesir Hospital Eduation and Research
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mustafa Akin, University of Health Sciences Balikesir Hospital Eduation and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301580
- Sponsor's protocol ID
- UHSBalikesirRadiationOnc
- Status last verified
- Oct 2025
- First submitted
- 27 Nov 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36269525Del 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.
PubMed 38642726