Trial Information

Taste and Smell Changes in Testicular Cancer Patients Treated With Cisplatin Based Chemotherapy

Rationale: 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. Objective: The primary objective is to investigate the nature,
prevalence, and duration of taste and smell changes in patients with disseminated testicular
cancer treated with cisplatin based chemotherapy. Secondary objectives are to explore the
short- and long-term consequences of these chemosensory changes for (medical) food
preference, dietary intake and quality of life, and to investigate the appreciation of
medical food products in these testicular cancer patients. Furthermore, it will be assessed
whether changes in taste and smell are related to the metabolic syndrome, and whether
chemotherapy induced neurotoxicity is related to changes in taste and smell. 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 population: Patients with disseminated testicular cancer treated with cisplatin based
chemotherapy. This group is selected, because of the young age at diagnosis, the emetogenic
chemotherapy treatment, the high survival rate, the increase in body mass index (BMI) and
risk of cardiovascular disease in the long-term.

Intervention: Gustatory function will be tested using filter-paper taste strips to measure
recognition thresholds for sweet, salty, sour and bitter taste. Olfactory function will be
tested using Sniffin' Sticks to measure odor threshold, discrimination and recognition.

Besides, patients have to fill out questionnaires to assess taste and smell subjectively and
to assess QoL. Food preference will be investigated by showing standardized photographs of
sweet and savory food products, varying in fat and protein content. In addition, a set of 10
Oral Nutrition Supplements (ONS) will be offered combined with a questionnaire to measure
appreciation and preference for these food products. All these tests and questionnaires will
be performed longitudinally (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 cross-sectional (1, 3, 5 and 7 years after chemotherapy). Two day food
records will be used to investigate the actual dietary intake before the first and second
course, during (on day 5 and 6) first and 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. A Food Frequency Questionnaire (FFQ) will be used to investigate the usual
dietary intake before the start of the first course, before and after the second course, 1
month after start of the last course, seven months after the start of chemotherapy, and 1
year after the start of chemotherapy (longitudinal), and 1, 3, 5 and 7 years after
chemotherapy (cross-sectional).

A Dual Energy X-ray Absortiometrys (DEXA) scan will be used to get insight in possible
changes in bone and fat mass during and after chemotherapy. To detect a possible cause of
taste and smell changes, audiogram will be performed (to measure cisplatin induced
neurotoxicity), and the baroreflex sensitivity (BRS) (to measure the quality of shortterm
blood pressure maintenance), the blood glucose tolerance, insulin resistance, and DNA for
SNP analysis will be collected. The DEXA scan, audiogram, BRS test, and blood glucose
tolerance test will be performed before the first course of chemotherapy, one month after
start of the last course, 1 year after the start of chemotherapy (longitudinal part), and 1,
3, 5 and 7 years after chemotherapy (cross-sectional part). A blood sample for DNA analysis
will be taken at the start of the chemotherapy (longitudinal part), and 1, 3, 5 and 7 years
after chemotherapy (cross-sectional part).