Clinical trial NCT06986005: The Effect of Neoadjuvant Chemotherapy on Physical Functions
Official title: Investigation of the Effect of Neoadjuvant Chemotherapy on Physical Functions in Women With Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Neoadjuvant Chemotherapy
Neoadjuvant Therapy
Keywords: physical functions
breast cancer
neoadjuvant chemotherapy
physiotherapy
fatigue
physical activity
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who are followed up by Pamukkale University Breast Polyclinic

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).

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Upper limb muscle strength
timeFrame: It is planned to repeat the measurements 2 times: baseline and after the procedure ofneoadjuvant chemotherapy.
measure: Lower limb muscle strength
timeFrame: It is planned to repeat the measurements 2 times: baseline and after the procedure ofneoadjuvant chemotherapy.
measure: 9 stair ascent and descent test
timeFrame: It is planned to repeat the measurements 2 times: baseline and after the procedure ofneoadjuvant chemotherapy.
measure: Balance assessment
timeFrame: It is planned to repeat the measurements 2 times: baseline and after the procedure ofneoadjuvant chemotherapy.
measure: Lower Extremity Function
timeFrame: It is planned to repeat the measurements 2 times: baseline and after the procedure ofneoadjuvant chemotherapy.
Secondary outcomes:
measure: Physical activity level
timeFrame: It is planned to repeat the measurements 2 times: baseline and after the procedure ofneoadjuvant chemotherapy.
measure: Fatigue
timeFrame: It is planned to repeat the measurements 2 times: baseline and after the procedure ofneoadjuvant chemotherapy.
measure: Determination of body weight and composition
timeFrame: It is planned to repeat the measurements 2 times: baseline and after the procedure ofneoadjuvant chemotherapy.
measure: Tissue dielectric constant measurement
timeFrame: It is planned to repeat the measurements 2 times: baseline and after the procedure ofneoadjuvant chemotherapy.
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
References: