Change of body composition in breast cancer: All-in Assessment
- Conditions
- Breast cancer10006291
- Registration Number
- NL-OMON44105
- Lead Sponsor
- Wageningen Universiteit
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 600
Breast cancer patients aged 18 or older, with newly diagnosed, incident, non-advanced (I-IIIA,), operable breast cancer in one of the participating hospitals. scheduled for initiating 2nd or 3rd generation adjuvant chemotherapy, no history of cancer or treatment with chemotherapy.
*Healthy* women without breast cancer, who are similar to the patient group as far as age (range, +/- 2 years).
A history of cancer or earlier treatment with chemotherapy, non-Dutch speaking, dementia or another mental condition that makes it impossible to fill out a questionnaire or answer 24hr recalls correctly or to participate in interviews and focus groups. An extra exclusion criteria for premenopausal women is a pregnancy or intention to get pregnant during participation in the study.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Study I focusses on possible determinants of changes in body composition and<br /><br>muscle strength. To assess changes in body composition, DEXA-scans will be made<br /><br>before start, shortly after and a half year after chemotherapy. Moreover,<br /><br>changes in muscle strength will be assessed by measuring hand-grip strength and<br /><br>knee-extensor strength.<br /><br>Study II assesses what the perceptions are of women with breast cancer, of<br /><br>women without breast cancer and of health care workers on potential changes in<br /><br>dietary intake, physical activity and quality of life and on possible<br /><br>interventions to curb those changes. To this end interviews and focus groups<br /><br>will be organised</p><br>
- Secondary Outcome Measures
Name Time Method <p>To assess if changes in body composition and abdominal fat distribution during<br /><br>chemotherapy are associated with body composition, fat distribution and energy<br /><br>balance before chemotherapy.<br /><br>To identify lifestyle and/or physiological markers related to changes in body<br /><br>composition and fat distribution during chemotherapy<br /><br>To assess differences in perceptions between premenopausal women (<40 year)<br /><br>with recently diagnosed breast cancer and premenopausal women without breast<br /><br>cancer and older women from both groups on changes in dietary intake, physical<br /><br>activity and quality of life<br /><br>To assess perceptions between women from another culture living in the<br /><br>Netherlands with recently diagnosed breast cancer and other women on dietary<br /><br>intake, physical activity and quality of life<br /><br>To assess perceptions of taste and smell between women with recently diagnosed<br /><br>breast cancer and other women </p><br>