Taste, Smell and Chemotherapy (TASTY)
Condition: Testicular Cancer
MeSH terms: Testicular Neoplasms
Study type: Interventional
Phase: Phase 4

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. 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.
    

Detailed description: 
      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).
    

Intervention name(s): Dexa scan; audiogram; measurement of heart rate variability and baroreflex sensitivity; Glucose tolerance assessment; oral nutrition supplements; Two day food records; Food Frequency Questionnaire
Intervention type(s): Procedure; Procedure; Procedure; Procedure; Dietary Supplement; Behavioral; Behavioral
Intervention description(s): the DEXA scan to measure bone and fat will be performed one time in the healthy controls and the patients participating in the cross sectional part of the study.
The patients in the longitudinal part of the study will have a DEXA scan at baseline, 1 month after the end of chemotherapy and after 1 year.; the audiogram will be performed one time in the healthy controls and the patients participating in the cross sectional part of the study.
The patients in the longitudinal part of the study will have an audiogram at baseline, 1 month after the end of chemotherapy and after 1 year.; the measurements (continuous assessment of heart rate and blood pressure using an non-invasive Finapress device) during 30 minutes will be performed one time in the healthy controls and the patients participating in the cross sectional part of the study.
The patients in the longitudinal part of the study will have those measurements taken at baseline, 1 month after the end of chemotherapy and after 1 year.; Glucose tolerance will be assessed by drinking glucose water and measuring glucose at baseline and 2 hours later. It will be performed one time in the healthy controls and the patients participating in the cross sectional part of the study.
The patients in the longitudinal part of the study will have an assessment at baseline, 1 month after the end of chemotherapy and after 1 year.; 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).
Other intervention name(s): Dual-energy X-ray absorptiometry; HRV; BRS; FFQ
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: taste; smell; cancer; nutrition