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Taste, Smell and Chemotherapy (TASTY) (TASTY)

Primary Purpose

Testicular Cancer

Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Dexa scan
audiogram
measurement of heart rate variability and baroreflex sensitivity
Glucose tolerance assessment
oral nutrition supplements
Two day food records
Food Frequency Questionnaire
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Testicular Cancer focused on measuring taste, smell, cancer, nutrition

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with disseminated testicular cancer undergoing first line cisplatin based chemotherapy (BEP or EP).
  • Age 18-50 years at start of treatment.
  • Signed informed consent.
  • Ability to comprehend Dutch (both reading and writing).
  • Complete remission after cisplatin based chemotherapy (BEP or EP) with or without adjunctive surgery and in active follow-up (only for crosssectional part of the study).

Exclusion Criteria:

  • Mental disability
  • Patients with co-morbidities that affect gustatory or olfactory function, such as rhinosinusitis, liver or renal problems, hyperactivity or hypoactivity of the thyroid gland, diabetes, or neurologic disorders (only for crosssectional part of the study).

Sites / Locations

  • University Medical Center Groningen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Patients

Healthy volunteers

Arm Description

Patients with disseminated testicular cancer

Healthy men, age 18-50 years old

Outcomes

Primary Outcome Measures

investigate the nature, prevalence, and duration of taste and smell changes
To investigate the nature, prevalence, and duration of taste and smell changes in patients with disseminated testicular cancer treated with cisplatin based chemotherapy (BEP (Bleomycin, Etoposide, cisPlatin) or EP (Etoposide, cisPlatin)). Tests used are: 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.

Secondary Outcome Measures

explore the short- and long-term consequences of taste and smell changes
To explore the short- and long-term consequences of taste and smell changes in relation to food preference, dietary intake, and quality of life. Tests used: QoL questionnaires (EORTC QLQ-C30). 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.
investigate the appreciation of medical food products
To investigate the appreciation of medical food products in patients with disseminated testicular cancer treated with cisplatin based chemotherapy. A set of 10 Oral Nutrition Supplements (ONS) will be offered combined with a questionnaire to measure appreciation and preference for these food products. Food preference will be investigated by showing standardized photographs of sweet and savory food products, varying in fat and protein content.
Are changes related to metabolic syndrome?
To assess whether changes in taste and smell are related to the metabolic syndrome. Tests used: glucose tolerance test and DEXA scan.
Is chemotherapy induced neurotoxicity related to changes?
To assess whether chemotherapy induced neurotoxicity is related to changes in taste and smell. TEsts used: audiogram, assessment of heart rate variability and baroreflex sensitivity.

Full Information

First Posted
January 25, 2012
Last Updated
April 14, 2016
Sponsor
University Medical Center Groningen
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1. Study Identification

Unique Protocol Identification Number
NCT01641172
Brief Title
Taste, Smell and Chemotherapy (TASTY)
Acronym
TASTY
Official Title
Taste and Smell Changes in Testicular Cancer Patients Treated With Cisplatin Based Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Testicular Cancer
Keywords
taste, smell, cancer, nutrition

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Active Comparator
Arm Description
Patients with disseminated testicular cancer
Arm Title
Healthy volunteers
Arm Type
Placebo Comparator
Arm Description
Healthy men, age 18-50 years old
Intervention Type
Procedure
Intervention Name(s)
Dexa scan
Other Intervention Name(s)
Dual-energy X-ray absorptiometry
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
audiogram
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
measurement of heart rate variability and baroreflex sensitivity
Other Intervention Name(s)
HRV, BRS
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Glucose tolerance assessment
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
oral nutrition supplements
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Two day food records
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Food Frequency Questionnaire
Other Intervention Name(s)
FFQ
Intervention Description
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).
Primary Outcome Measure Information:
Title
investigate the nature, prevalence, and duration of taste and smell changes
Description
To investigate the nature, prevalence, and duration of taste and smell changes in patients with disseminated testicular cancer treated with cisplatin based chemotherapy (BEP (Bleomycin, Etoposide, cisPlatin) or EP (Etoposide, cisPlatin)). Tests used are: 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.
Time Frame
baseline, day 7 of first course, before 2nd course, day 7 2nd course, 1 month after start of last course, 7 months after start of chemotherapy, 1 year after start study; 1, 3, 5 and 7 years after chemotherapy.
Secondary Outcome Measure Information:
Title
explore the short- and long-term consequences of taste and smell changes
Description
To explore the short- and long-term consequences of taste and smell changes in relation to food preference, dietary intake, and quality of life. Tests used: QoL questionnaires (EORTC QLQ-C30). 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.
Time Frame
baseline, day 7 of first course, before 2nd course, day 7 2nd course, 1 month after start of last course, 7 months after start of chemotherapy, 1 year after start study; 1, 3, 5 and 7 years after chemotherapy.
Title
investigate the appreciation of medical food products
Description
To investigate the appreciation of medical food products in patients with disseminated testicular cancer treated with cisplatin based chemotherapy. A set of 10 Oral Nutrition Supplements (ONS) will be offered combined with a questionnaire to measure appreciation and preference for these food products. Food preference will be investigated by showing standardized photographs of sweet and savory food products, varying in fat and protein content.
Time Frame
baseline, day 7 of first course, before 2nd course, day 7 2nd course, 1 month after start of last course, 7 months after start of chemotherapy, 1 year after start study; 1, 3, 5 and 7 years after chemotherapy.
Title
Are changes related to metabolic syndrome?
Description
To assess whether changes in taste and smell are related to the metabolic syndrome. Tests used: glucose tolerance test and DEXA scan.
Time Frame
baseline, 1 month after start of last course, 1 year after start study; 1, 3, 5 and 7 years after chemotherapy.
Title
Is chemotherapy induced neurotoxicity related to changes?
Description
To assess whether chemotherapy induced neurotoxicity is related to changes in taste and smell. TEsts used: audiogram, assessment of heart rate variability and baroreflex sensitivity.
Time Frame
baseline, 1 month after start of last course, 1 year after start study; 1, 3, 5 and 7 years after chemotherapy.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with disseminated testicular cancer undergoing first line cisplatin based chemotherapy (BEP or EP). Age 18-50 years at start of treatment. Signed informed consent. Ability to comprehend Dutch (both reading and writing). Complete remission after cisplatin based chemotherapy (BEP or EP) with or without adjunctive surgery and in active follow-up (only for crosssectional part of the study). Exclusion Criteria: Mental disability Patients with co-morbidities that affect gustatory or olfactory function, such as rhinosinusitis, liver or renal problems, hyperactivity or hypoactivity of the thyroid gland, diabetes, or neurologic disorders (only for crosssectional part of the study).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A KL Reyners, MD, PhD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands

12. IPD Sharing Statement

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Taste, Smell and Chemotherapy (TASTY)

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