NCT07070778

Brief Summary

The aim of this study was to evaluate vascular toxicity induced by anthracyclines and other anticancer drugs and to measure arterial stiffness in women with breast cancer and, in addition, to evaluate the acute and chronic arterial stiffness responses of upper extremity aerobic exercise training.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
6mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Jul 2025Dec 2026

Study Start

First participant enrolled

July 8, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 9, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 17, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

1.3 years

First QC Date

July 9, 2025

Last Update Submit

December 25, 2025

Conditions

Keywords

breast cancerAerobic exercise trainingArterial Stiffness

Outcome Measures

Primary Outcomes (1)

  • Arterial Stiffness

    Arterial stiffness will be assessed noninvasively using the pulse wave velocity (PWV) technique with the Mobil-O-GRAPH (TG) (I.E.M., Stolberg, Germany), an oscillometer-based device. Pulse wave velocity, augmentation pressure, reflection magnitude, agumentation index parameters will be recorded.

    one years

Secondary Outcomes (3)

  • Comorbidity Assessment

    one year

  • Maximal Arm Exercise Capacity

    one year

  • Cardiovascular Disease Risk Scoring

    one year

Study Arms (1)

Upper Extremity Aerobic Exercise

OTHER

Participants will only receive a 12-week upper extremity aerobic exercise training program.

Other: Upper Extremity Aerobic Exercise Training Program

Interventions

12 weeks of supervised upper limb aerobic exercise training, 3 sessions per week, 25 minutes per session.

Upper Extremity Aerobic Exercise

Eligibility Criteria

Age40 Years - 69 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be between the ages of 40-69,
  • Baseline left ventricular ejection fraction (LVEF) \>50%,
  • Absence of coronary artery disease and haemodynamically significant valvular heart disease,
  • Absence of carotid atherosclerotic plaques,
  • Volunteering to participate in the research,
  • At least 15 months after breast cancer surgery,
  • No problems in reading and/or understanding the scales and being able to co-operate with the tests.
  • Physically inactive (60 minutes of structured exercise per week \<).

You may not qualify if:

  • Presence of active infection,
  • Presence of bilateral breast cancer,
  • History of surgical, neurological or orthopaedic problems that may affect upper extremity functionality other than breast cancer surgery,
  • Having a neurological disease or other clinical diagnosis that may affect cognitive status,
  • Left ventricular dysfunction and severe liver and kidney dysfunction before starting chemotherapy
  • Musculoskeletal and neurological disease that may affect exercise performance, symptomatic heart disease, previous lung surgery and malignant disease.
  • Presence of unstable hypertension or diabetes mellitus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, State, 06100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Melda Saglam, PhD

    Hacettepe University

    STUDY CHAIR
  • Ebru Calik Kutukcu, PhD

    Hacettepe University

    STUDY DIRECTOR

Central Study Contacts

Ebru Calik Kutukcu, PhD

CONTACT

Naciye Vardar-Yagli, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The study consists of one group: this group performs upper extremity aerobic exercise training.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 9, 2025

First Posted

July 17, 2025

Study Start

July 8, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

December 29, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations