Change of body composition in breast cancer: All-in Assessment

Change of body composition in breast cancer: All-in Assessment - COBRA-study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON44105

Enrollment

600

Registered

2012-12-14

Start date

2013-05-15

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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).

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Study I focusses on possible determinants of changes in body composition and muscle strength. To assess changes in body composition, DEXA-scans will be made before start, shortly after and a half year after chemotherapy. Moreover, changes in muscle strength will be assessed by measuring hand-grip strength and knee-extensor strength. Study II assesses what the perceptions are of women with breast cancer, of women without breast cancer and of health care workers on potential changes in dietary intake, physical activity and quality of life and on possible interventions to curb those changes. To this end interviews and focus groups will be organised	—

Measure

Time frame

Study I focusses on possible determinants of changes in body composition and muscle strength. To assess changes in body composition, DEXA-scans will be made before start, shortly after and a half year after chemotherapy. Moreover, changes in muscle strength will be assessed by measuring hand-grip strength and knee-extensor strength. Study II assesses what the perceptions are of women with breast cancer, of women without breast cancer and of health care workers on potential changes in dietary intake, physical activity and quality of life and on possible interventions to curb those changes. To this end interviews and focus groups will be organised

—

Secondary

Measure	Time frame
To assess if changes in body composition and abdominal fat distribution during chemotherapy are associated with body composition, fat distribution and energy balance before chemotherapy. To identify lifestyle and/or physiological markers related to changes in body composition and fat distribution during chemotherapy To assess differences in perceptions between premenopausal women (	—

Countries

Netherlands

Outcome results