NCT06859593

Brief Summary

Breast cancer is one of the most common cancers among women worldwide, with an incidence rate of up to 16%. Although survival can be improved with early diagnosis and more effective therapies, physical complications such as lymphedema, upper extremity dysfunction and chronic pain are common during and/or after breast cancer treatments. In addition, lymphedema can cause symptoms such as decreased muscle strength and range of motion of the upper extremity, pain and fatigue, resulting in activity limitations and decreased functional level of the upper extremity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

July 9, 2025

Status Verified

July 1, 2025

Enrollment Period

2 months

First QC Date

February 28, 2025

Last Update Submit

July 8, 2025

Conditions

Keywords

breast cancerupper extremity6-minute pegboard and ring testexercise capacity

Outcome Measures

Primary Outcomes (1)

  • Upper Extremity Exercise Capacity

    6-Minute Pegboard and Ring Test

    One Year

Secondary Outcomes (3)

  • Evaluation of Upper Extremity Functionality

    One Year

  • Lymphedema Evaluation

    One Year

  • Measurement of arm length, arm and forearm circumference

    One Year

Study Arms (2)

Breast Cancer Group

Inclusion criteria were to be between 18-65 years of age, to volunteer to participate in the study, to have Stage I-III breast cancer, to have at least 15 months after breast cancer surgery, to have six months after active breast cancer treatment (i.e. surgery/chemotherapy), to have no problems in reading and/or understanding the scales and to be able to cooperate with the tests. Exclusion criteria were the presence of active infection, musculoskeletal and neurologic disease that may affect exercise performance, symptomatic heart disease, neurologic disease or other clinical diagnosis that may affect cognitive status.

Diagnostic Test: Upper Extremity Exercise Capacity, 6-Minute Pegboard And Ring Test

Control Group

The inclusion criteria were to be between 18-65 years of age, to be willing to participate in the study, to have no problems in reading and/or understanding the scales and to be able to cooperate with the tests. Exclusion criteria were having any orthopedic or neuromuscular condition that would interfere with walking or exercise performance, having any chronic disease, or having psychiatric disorders or mental disorders that might interfere with cooperation or compliance with exercise tests.

Diagnostic Test: Upper Extremity Exercise Capacity, 6-Minute Pegboard And Ring Test

Interventions

Upper Extremity Exercise Capacity

Breast Cancer GroupControl Group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients between the ages of 18-65 years who are diagnosed with breast cancer at Hacettepe University Hospital, Department of Internal Medicine, Division of Medical Oncology, and who volunteer to participate in the study will be included in the study. For healthy groups, age and gender appropriate volunteers will be recruited for the study

You may qualify if:

  • Breast Cancer Group:
  • Being between 18-65 years of age,
  • Volunteering to participate in the research,
  • Stage I-III breast cancer,
  • At least 15 months after breast cancer surgery,
  • Six months after active breast cancer treatment (i.e. surgery/chemotherapy),
  • No problems in reading and/or understanding the scales and being able to cooperate with the tests,
  • Healthy group:
  • Age between 18-65 years,
  • Volunteering to participate in the research,
  • No problems in reading and/or understanding the scales and being able to cooperate with the tests.

You may not qualify if:

  • Breast Cancer Group:
  • Presence of active infection,
  • Musculoskeletal and neurological diseases that may affect exercise performance, symptomatic heart disease,
  • Having a neurological disease or other clinical diagnosis that may affect cognitive status.
  • Healthy group:
  • Having any orthopedic or neuromuscular condition that would interfere with walking or exercise performance,
  • Having any chronic disease or psychiatric disorders or mental impairments that may interfere with cooperation or compliance with exercise tests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hcettepe University, Ankara, State 06100

Ankara, State, 06100, Turkey (Türkiye)

Location

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

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 28, 2025

First Posted

March 5, 2025

Study Start

March 1, 2025

Primary Completion

May 1, 2025

Study Completion

June 1, 2025

Last Updated

July 9, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations