Primary Objective: To investigate the nature, prevalence, and duration of taste and smell changes in patients with disseminated testicular cancer treated with cisplatin based chemotherapy (BEP or EP).Secondary Objective(s): -To explore the short-…
ID
Source
Brief title
Condition
- Other condition
- Reproductive neoplasms male malignant and unspecified
Synonym
Health condition
smaak- en geurfunctie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Scores of gustatory and olfactory function of patients with disseminated
testicular cancer treated with cisplatin based chemotherapy will be
investigated using physiological tests (taste strips and *Sniffin* Sticks*) and
using a questionnaire on taste and smell function to investigate the subjective
perception of taste and smell function among these patients. During the
chemotherapeutic treatment the measurements will be re-assessed several times
to investigate possible changes in gustatory and olfactory function before,
during and after chemotherapy. Measurements will also be carried out 1, 3, 5
and 7 years after chemotherapy to investigate possible changes in gustatory and
olfactory function in the long-term.
Secondary outcome
The secondary parameters are food preference, dietary intake, quality of life,
BMI, body composition (bone and fat mass), audiograms, BRS, blood glucose level
and DNA. We will focus on changes in these parameters due to changes in
gustatory and olfactory function as a consequence of chemotherapy.
Background summary
Taste and smell abnormalities are common in cancer patients undergoing
chemotherapy, with a prevalence ranging from 46% to 77% for taste changes, and
35% to 75% for smell changes. These chemosensory changes are distressing for
patients and can lead to changes in appetite, food choice, and nutrient intake.
These changes can result in malnutrition and weight loss. Possibly, also
unhealthy eating patterns can be developed due to these taste and smell
changes, given the high prevalence of obesity among survivors of certain cancer
types.
Study objective
Primary Objective:
To investigate the nature, prevalence, and duration of taste and smell changes
in patients with disseminated testicular cancer treated with cisplatin based
chemotherapy (BEP or EP).
Secondary Objective(s):
-To explore the short- and long-term consequences of taste and smell changes in
relation to food preference, dietary intake, and quality of life in patients
with disseminated testicular cancer treated with cisplatin based chemotherapy.
-To investigate the appreciation of (medical) food products in patients with
disseminated testicular cancer treated with cisplatin based chemotherapy.
Study design
The present study will have a longitudinal (with measurements before the first
chemotherapy, on day 7 of the first course, before the second course, on day 7
of the second course, 1 month after start of the last course, 7 months after
the start of chemotherapy, and 1 year after the start of chemotherapy) and a
cross-sectional (with measurements 1, 3, 5 and 7 years after chemotherapy)
design. Patients can start participation in this study before the start of
their chemotherapy, which will result in longitudinal data of these patients or
they can start participation years after treatment, resulting in
cross-sectional data.
Study burden and risks
Performing the measurements, and filling out the questionnaires is considered
as a minimal burden for the testicular cancer patients. With this study we hope
to get insight into the nature, prevalence, and duration of taste and smell
changes and their significance for food preference, dietary intake and quality
of life. With knowledge regarding taste and smell changes, a better prediction
on food acceptance can be given at the start, during, and after chemotherapy to
maintain a healthy eating pattern or, if necessary, improve the diet. Besides,
this research will yield valuable information for industry with regard to
further research and development in (medical) food products.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
Cancer patients:
- Testicular cancer patients treated with cisplatin based chemotherapy
- Age range 18-50
- Ability to comprehend Dutch (both reading and writing)
- Signed informed consent;Healthy controls:
- Healthy males
- Age 18-50 years
- Ability to comprehend Dutch (both reading and writing)
- Signed informed consent
Exclusion criteria
Cancer patients
- Mental disability
-Smoking (cross-sectional part);Healthy controls:
- Mental disability
- Ever diagnosed with cancer
- History of taste and smell abnormalities
- Smoking (cross-sectional part)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL38757.042.11 |