The Effect of Neoadjuvant Chemotherapy on Physical Functions

ATİYE KAŞ ÖZDEMİR

Status: Enrolling

Conditions: Breast Cancer; Neoadjuvant Chemotherapy; Neoadjuvant Therapy

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

Study type: Observational

Funder types: Other

Identifiers

NCT06986005

E-60116787-020-642610

Details and patient eligibility

About

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).

Full 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.

Enrollment: 46 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

46 participants in 1 patient group

Breast cancer patients receiving neoadjuvant chemotherapy

Description:

Breast cancer patients who receiving neoadjuvant chemotherapy

Treatment:

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