Breast CancerNCT06986005
The Effect of Neoadjuvant Chemotherapy on Physical Functions
An observational study of Breast Cancer and Neoadjuvant Chemotherapy, run by ATİYE KAŞ ÖZDEMİR at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer, Neoadjuvant Chemotherapy, Neoadjuvant Therapy
- How many people
- 67 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jan 2025to 15 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Individuals who are followed up by Pamukkale University Breast Polyclinic
Who may be able to join
- Individuals who are planned to receive neoadjuvant chemotherapy for breast cancer
- Acceptance to participate in the study
Who cannot join
- Previous history of breast cancer
- History of any other cancer
- Refusal to participate in the study
- Refusal to continue working
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Neoadjuvant Chemotherapy on Physical Functions in Women With Breast Cancer
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).
Read the detailed description
As a result of the power analysis made from the reference study; when the effect size d=0.8, it was calculated that 80% power could be obtained at 95% confidence level when at least 42 people were included in the study. Considering that a lower effect size can also be obtained, it is planned to complete the study with at least 46 participants by taking 10% more participants.
The data will be analysed with SPSS 25.0 package programme. Continuous variables will be given as mean ± standard deviation and categorical variables as number and percentage. When parametric test assumptions are met, the Significance Test of the Difference Between Two Means will be used to compare independent group differences; when parametric test assumptions are not met, the Mann-Whitney U test will be used to compare independent group differences. In dependent group comparisons, repeated measures analysis of variance will be used when parametric test assumptions are met; Friedman test will be used when parametric test assumptions are not met. In addition, the relationships between continuous variables will be examined by Spearman or Pearson correlation analyses and the differences between categorical variables will be examined by Chi-square analysis.
- Conditions
- Breast Cancer, Neoadjuvant Chemotherapy, Neoadjuvant Therapy
- Being tested
- No intervention will be performed as part of this study. However, regardless of the study, all participants will receive neoadjuvant chemotherapy.
- Keywords
- physical functions, breast cancer, neoadjuvant chemotherapy, physiotherapy, fatigue, physical activity
- Medical subject headings
- Breast Neoplasms, Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients receiving neoadjuvant chemotherapy | Breast cancer patients who receiving neoadjuvant chemotherapy Receives: Other: No intervention will be performed as part of this study. However, regardless of the study, all participants will receive neoadjuvant chemotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: It is planned to repeat the measurements 2 times: baseline and after the procedure ofneoadjuvant chemotherapy.
Secondary outcomes (4)
Physical activity level
The Global Physical Activity Questionnaire, which is a self-report form consisting of 16 questions prepared by the World Health Organisation (WHO), will be used.
Measured: It is planned to repeat the measurements 2 times: baseline and after the procedure ofneoadjuvant chemotherapy.
Fatigue
The Multidimensional Fatigue Rating Scale will be used to measure the fatigue levels of the participants.
Measured: It is planned to repeat the measurements 2 times: baseline and after the procedure ofneoadjuvant chemotherapy.
Determination of body weight and composition
The weight of the participants will be measured directly with a Tanita device that works with the segmental multi-frequency bioelectrical impedance analysis method. The Tanita Bady Fat Monitor works with the Bioelectrical Impedance Analysis technique. This method analyses the composition of the body. An imperceptible, very weak and body-safe electric current circulates in the fluid inside the muscles. When the current encounters the fat layer, it encounters resistance, the layers showing resistance are evaluated by the device, compared with weight and height and displayed on the digital screen as fat ratio.
Measured: It is planned to repeat the measurements 2 times: baseline and after the procedure ofneoadjuvant chemotherapy.
Tissue dielectric constant measurement
Subdermal fluid measurements by tissue dielectric constant are one of the best methods to diagnose and localise early lymphoedema and also to identify a number of non-lymphoedema patients potentially at risk for later lymphoedema formation. Tissue dielectric constant will be determined by measuring the sub-tissue fluid density of the individuals at defined reference points using a Moisture Meter-D compact (MMDc, Delfin Technologies, Finland).
Measured: It is planned to repeat the measurements 2 times: baseline and after the procedure ofneoadjuvant chemotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start8 Jan 2025
- Primary completion10 Jul 2025
- Study completion15 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- ATİYE KAŞ ÖZDEMİR
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ATİYE KAŞ ÖZDEMİR, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06986005
- Sponsor's protocol ID
- E-60116787-020-642610
- Status last verified
- Feb 2026
- First submitted
- 4 May 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Neoadjuvant Chemotherapy on Physical Functions in Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT06986005
- Acronym / sponsor ID
- E-60116787-020-642610
- Conditions
- Breast Cancer, Neoadjuvant Chemotherapy, Neoadjuvant Therapy
- Keywords
- physical functions, breast cancer, neoadjuvant chemotherapy, physiotherapy, fatigue, physical activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- ATİYE KAŞ ÖZDEMİRUniversity, hospital or other
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 15 Nov 2025 (actual)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
As a result of the power analysis made from the reference study; when the effect size d=0.8, it was calculated that 80% power could be obtained at 95% confidence level when at least 42 people were included in the study. Considering that a lower effect size can also be obtained, it is planned to complete the study with at least 46 participants by taking 10% more participants.
The data will be analysed with SPSS 25.0 package programme. Continuous variables will be given as mean ± standard deviation and categorical variables as number and percentage. When parametric test assumptions are met, the Significance Test of the Difference Between Two Means will be used to compare independent group differences; when parametric test assumptions are not met, the Mann-Whitney U test will be used to compare independent group differences. In dependent group comparisons, repeated measures analysis of variance will be used when parametric test assumptions are met; Friedman test will be used when parametric test assumptions are not met. In addition, the relationships between continuous variables will be examined by Spearman or Pearson correlation analyses and the differences between categorical variables will be examined by Chi-square analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients 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.Breast cancer patients who receiving neoadjuvant chemotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who are followed up by Pamukkale University Breast Polyclinic
Key inclusion criteria (2 listed)
- Individuals who are planned to receive neoadjuvant chemotherapy for breast cancer
- Acceptance to participate in the study
Key exclusion criteria (4 listed)
- Previous history of breast cancer
- History of any other cancer
- Refusal to participate in the study
- Refusal to continue working
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention will be performed as part of this study. However, regardless of the study, all participants will receive neoadjuvant chemotherapy.All participants will receive neoadjuvant chemotherapy appropriate to the characteristics of their breast cancer as part of their standard care. | Other | Breast cancer patients receiving neoadjuvant chemotherapy |
Primary outcome
Upper limb muscle strength
Time frame: It is planned to repeat the measurements 2 times: baseline and after the procedure ofneoadjuvant chemotherapy.
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.
Lower limb muscle strength
Time frame: It is planned to repeat the measurements 2 times: baseline and after the procedure ofneoadjuvant chemotherapy.
Lower extremity muscle strength will be measured with Hand Held Dynamometer.
9 stair ascent and descent test
Time frame: It is planned to repeat the measurements 2 times: baseline and after the procedure ofneoadjuvant chemotherapy.
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.
Balance assessment
Time frame: It is planned to repeat the measurements 2 times: baseline and after the procedure ofneoadjuvant chemotherapy.
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.
Lower Extremity Function
Time frame: It is planned to repeat the measurements 2 times: baseline and after the procedure ofneoadjuvant chemotherapy.
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.
4 secondary outcomes
Physical activity level
Time frame: It is planned to repeat the measurements 2 times: baseline and after the procedure ofneoadjuvant chemotherapy.
Fatigue
Time frame: It is planned to repeat the measurements 2 times: baseline and after the procedure ofneoadjuvant chemotherapy.
Determination of body weight and composition
Time frame: It is planned to repeat the measurements 2 times: baseline and after the procedure ofneoadjuvant chemotherapy.
Tissue dielectric constant measurement
Time frame: It is planned to repeat the measurements 2 times: baseline and after the procedure ofneoadjuvant chemotherapy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Neoadjuvant Chemotherapy, run by ATİYE KAŞ ÖZDEMİR at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper limb muscle strength (time frame: It is planned to repeat the measurements 2 times: baseline and after the procedure ofneoadjuvant chemotherapy.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.