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

Yearly, more than 60% of the 13,000 Dutch women diagnosed with breast cancer
will receive adjuvant chemotherapy (CT) of which weight gain can be an
important side-effect. American studies suggest that this weight gain consists
of increases in fat mass with loss or no change in muscle mass leading to
sarcopenic obesity. Moreover, muscle strength may weaken, leading to dynapenic
obesity. Changes in body composition and muscle strength affect quality of life
and increase the risk of disease recurrence, cardiovascular disease and
diabetes.
It is not clear whether changes are indeed treatment-related as only few
studies compared changes during CT with changes *normally* occurring over time.

The aims of this project are to:
1. Assess what percentage of breast cancer patients experience accelerated
gain in fat mass, loss of muscle mass and muscle strength as induced during
chemotherapy
2. Assess whether changes in energy intake, protein intake and physical
activity are associated with accelerated changes in body composition and muscle
strength
3. Assess perceptions of women with breast cancer, women without breast
cancer and health care workers on why potential changes in dietary intake,
physical activity and quality of life occur
4. Assess how taste and odour perception changes during chemotherapy.

In order to plan and design a future intervention to reduce the occurrence of
changes in body composition, the study also aims to:
1. Identify subgroups of women especially susceptible for changes in body
composition and muscle strength
2. Assess perceptions of women with breast cancer, women without breast
cancer and health care workers on possible interventions to curb changes in
dietary intake, physical activity and quality of life

The COBRA-study consist of 2 parts with different study techniques. A
quantitative part and a qualitative part.

the quantitative part is an observational study among breast cancer patients
(n=300) and among a comparison group of women without breast cancer (n=300)
matched on age (range, +/- 2years). There are four moments of measurement in
this study. For women with breast cancer this moments are: before start of the
chemotherapy (CT), during CT, at the end of CT (1-3 weeks after the last cycle)
and 6 months after CT. For women without breast cancer these moments are: at
baseline, 3 months, 6 months and after 1 year.

We ask women who participate in this study to fill-out different questionnaires
about, lifestyle, food intake, physical activity, fatigue, depression and
quality of life. In addition, blood samples will be drawn and we will perform
different measurements. Participants are asked to underwent three times
bio-impadance spectrometry and a DEXA-scan. Muscle strength will be assessed
three times by hand grip strength, Sit-to-stand test and knee extensor
strength. physical activity will be measured in two ways, with questionnaires
and with accelerometers. The accelerometer has to be worn during a week at each
moment of measurement. In addition, participants will complete four times a 24
hour recall about their food intake during a (telephone) interview.

Women in the comparison group (without breast cancer), will have the same
questionnaires and measurements.

A sub group of 30 patients and 30 controls will be asked to participate in four
extra measurements regarding taste and smell perception as well as food
preference tests.

During the qualitative part of this study women with and without breast cancer
will be interviewed four and two times, respectively followed by one or more
focus groups. the number of interviews and focus groups is dependent on
saturation. In addition, health care workers will be interviewed once, followed
by one or more focus groups. Women from not-western culture with breast cancer
will also be interviewed followed by one or more focus groups.

Participants for study 2 will mainly be sampled from the study population of
study 1. This will enable combining parts of the results of the qualitative
study with the measurements of the quantitative study (mixed methods approach).

This table shows the measurements taking place during each moment of
measurement.

Before CT During CT At end of
CT 6 months after CT

Study I:
questionnaires 1 22
3 4
blood sample 1 2
3 4
body measurements 1
3 4
physical activity 1
2 3 4
24 h recall(tel) 22

Taste and smell test 1
2 3 4
Food preference test 1
2 3 4


Study II:
Interviews 1
2 3 4
Focus groups after the interviews

The burden for patients and women of the comparison group fluctuates over time
and depends also on whether or not subjects participate in the subgroups or
study 2. Upon recruitment patients and women in the comparison group have to
fill out several questionnaires, donate a blood sample. Moreover DEXA-scans
will be performed, muscle strength will be assessed. In addition, the subjects
will be asked to wear an accelerometer (which will be sent to them by mail) for
7 consecutive days, During chemotherapy, (or at 3 months for the comparison
group), subjects will be asked about dietary intake with telephone based
24h-recalls: to this end, a dietician will call the subjects and will collect
information during an interview of maximal 30 minutes. Moreover, the subjects
will be asked to wear an accelerometer again. Shortly after the end of
chemotherapy and 6 months after the end of chemotherapy (or at 6 and 12 months
for the comparison group)*, they will again be asked to fill out several
questionnaires and to donate a blood sample. Moreover DEXA-scans will be
performed and muscle strength will be assessed and the subjects will be asked
to wear an accelerometer.


Women who participate in extra test sessions for taste and smell will be
visited four time at their home. During these sessions they will complete
taste, smell and food preference tests.

Participants of study 2 will (predominantly) be selected from the study
population of study 1. This will enable combining results of the qualitative
study with measurements of the quantitative study. Participants of study 2 will
be asked for an interview, which will take place at their home, and for focus
groups, which will take place at a central place. Participants who take part in
study 2 will not be asked for subgroups of study 1.

* from june 2016 onwards, the measurements of Dexa-scan and muscle strength are
omitted for the comparison group.