The Effect of Neoadjuvant Chemotherapy on Physical Functions

NCT06986005 | Completed

• 1 other identifier: E-60116787-020-642610
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this observational study was to investigate the effect of neoadjuvant chemotherapy on physical functioning in individuals with breast cancer. The main question that the study aims to answer is how the physical functions of individuals are after neoadjuvant chemotherapy. Demographic information of the participants will be recorded and their physical status will be evaluated by determining body weight and composition, 30-second sit-and-stand test, 9-step stair ascent and descent test, one-leg stand test, upper extremity muscle strength test, lower extremity muscle strength test, tissue dielectric constant measurement, Lower Extremity Functional Scale, Global Physical Activity Questionnaire and Multidimensional Fatigue Rating Scale. In these patients who are planned to receive neoadjuvant chemotherapy for breast cancer, measurements will be made before chemotherapy (T1) and after chemotherapy (T2).

Conditions

Breast Cancer; Neoadjuvant Chemotherapy; Neoadjuvant Therapy

Keywords

physical functions; breast cancer; neoadjuvant chemotherapy; physiotherapy; fatigue; physical activity

Outcome Measures

Primary Outcomes (5)

• Upper limb muscle strength

  Since hand grip strength is correlated with upper extremity muscle strength as well as general body muscle strength and pulmonary muscle strength, upper extremity muscle strength will be evaluated by hand dynamometer.

  It is planned to repeat the measurements 2 times: baseline and after the procedure ofneoadjuvant chemotherapy.

• Lower limb muscle strength

  Lower extremity muscle strength will be measured with Hand Held Dynamometer.

  It is planned to repeat the measurements 2 times: baseline and after the procedure ofneoadjuvant chemotherapy.

• 9 stair ascent and descent test

  A 9-step stair ascent and descent test will be used to assess the patient's stair ascent and descent activity, dynamic balance and lower extremity strength.

  It is planned to repeat the measurements 2 times: baseline and after the procedure ofneoadjuvant chemotherapy.

• Balance assessment

  Balance will be assessed in two stages: static and dynamic balance. Standing on one leg test will be used as static balance assessment and 30 seconds sit-and-stay test will be used for dynamic balance assessment.

  It is planned to repeat the measurements 2 times: baseline and after the procedure ofneoadjuvant chemotherapy.

• Lower Extremity Function

  The Lower Extremity Functional Scale developed by Binkley et al. (1999) to evaluate lower extremity function, activity limitations of individuals, lower extremity functions and abilities in patients with musculoskeletal disorders will be used.

  It is planned to repeat the measurements 2 times: baseline and after the procedure ofneoadjuvant chemotherapy.

Secondary Outcomes (4)

• Physical activity level

  It is planned to repeat the measurements 2 times: baseline and after the procedure ofneoadjuvant chemotherapy.

• Fatigue

  It is planned to repeat the measurements 2 times: baseline and after the procedure ofneoadjuvant chemotherapy.

• Determination of body weight and composition

  It is planned to repeat the measurements 2 times: baseline and after the procedure ofneoadjuvant chemotherapy.

• Tissue dielectric constant measurement

  It is planned to repeat the measurements 2 times: baseline and after the procedure ofneoadjuvant chemotherapy.

Study Arms (1)

Breast cancer patients receiving neoadjuvant chemotherapy

Breast cancer patients who receiving neoadjuvant chemotherapy

Other: No intervention will be performed as part of this study. However, regardless of the study, all participants will receive neoadjuvant chemotherapy.

Interventions

No intervention will be performed as part of this study. However, regardless of the study, all participants will receive neoadjuvant chemotherapy. OTHER

All participants will receive neoadjuvant chemotherapy appropriate to the characteristics of their breast cancer as part of their standard care.

Breast cancer patients receiving neoadjuvant chemotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals who are followed up by Pamukkale University Breast Polyclinic

You may qualify if:

• Individuals who are planned to receive neoadjuvant chemotherapy for breast cancer
• Acceptance to participate in the study

You may not qualify if:

• Previous history of breast cancer
• History of any other cancer
• Refusal to participate in the study
• Refusal to continue working

Sponsors & Collaborators

• ATİYE KAŞ ÖZDEMİR: lead

Study Sites (1)

Pamukkale University

Denizli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms; Fatigue; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer PhD.

Study Record Dates

• First Submitted: May 4, 2025
• First Posted: May 22, 2025
• Study Start: January 8, 2025
• Primary Completion: July 10, 2025
• Study Completion: November 15, 2025
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)