Breast Cancer, Hormonal Therapy
Conditions
Keywords
Body composition
Brief summary
This cross-sectional study of pathophysiology will bring additional informations on body composition of patients treated by adjuvant hormonal therapy for breast cancer. This is a complementary study of Metaca study (AU882).
Interventions
DXA, impedance
Sponsors
Centre Jean Perrin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* postmenopausal women * patients requiring hormonal treatment * WHO performance status 0-2 * patients initially included in MetaCa (AU882) protocol * Affiliation to a social security scheme (or be the beneficiary of such a plan) * patients who signed the informed consent form
Exclusion criteria
* patients witg relapse, with metastases or other cancer * concurrent treatment with a drug test, or participation in a clinical trial within \< 30 days * patients carrying an electronic medical device (eg pacemaker) * patients who refused to sign the consent form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure of body composition | After more than a year of hormonal therapy | To obtain additional data to those of Metaca study (AU882) to assess changes in body composition (fat mass, lean body mass in Kg) in women with breast cancer and treated with adjuvant hormonal therapy following chemotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the distribution of abdominal fat by measuring the waist and hip circumference | After more than a year of hormonal therapy | — |
| Assessment of anxiety and depression scores measured by Questionnaire HAD | After more than a year of hormonal therapy | Questionnaire HAD |
| Evaluation of quality of life measured by Questionnaire (QLQ-C30) | After more than a year of hormonal therapy | Questionnaire (QLQ-C30) |
| Evaluation of the time sitting measured by Questionnaire IPAQ | After more than a year of hormonal therapy | Questionnaire IPAQ |
| Evaluate the change in body composition longitudinally from the data of the study Metaca | Between after 1 and 6 months after chemotherapy and after more than a year of hormonal therapy | — |
Countries
France
Outcome results
None listed