Taste, Smell and Chemotherapy (TASTY)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University Medical Centre Groningen
Sponsor:
Information provided by (Responsible Party):
A.K.L. Reyners, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01641172
First received: January 25, 2012
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Testicular Cancer
Procedure: Dexa scan
Procedure: audiogram
Procedure: measurement of heart rate variability and baroreflex sensitivity
Procedure: Glucose tolerance assessment
Dietary Supplement: oral nutrition supplements
Behavioral: Two day food records
Behavioral: Food Frequency Questionnaire
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Taste and Smell Changes in Testicular Cancer Patients Treated With Cisplatin Based Chemotherapy

Resource links provided by NLM:


Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • investigate the nature, prevalence, and duration of taste and smell changes [ 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. ] [ Designated as safety issue: No ]

    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 [ 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. ] [ Designated as safety issue: No ]
    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 [ 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. ] [ Designated as safety issue: No ]

    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? [ Time Frame: baseline, 1 month after start of last course, 1 year after start study; 1, 3, 5 and 7 years after chemotherapy. ] [ Designated as safety issue: No ]

    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? [ Time Frame: baseline, 1 month after start of last course, 1 year after start study; 1, 3, 5 and 7 years after chemotherapy. ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 140
Study Start Date: June 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Patients
Patients with disseminated testicular cancer
Procedure: Dexa scan

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.

Other Name: Dual-energy X-ray absorptiometry
Procedure: audiogram

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.

Procedure: measurement of heart rate variability and baroreflex sensitivity

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.

Other Names:
  • HRV
  • BRS
Procedure: Glucose tolerance assessment

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.

Dietary Supplement: oral nutrition supplements
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).
Behavioral: Two day food records
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.
Behavioral: Food Frequency Questionnaire
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 Name: FFQ
Placebo Comparator: Healthy volunteers
Healthy men, age 18-50 years old
Procedure: Dexa scan

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.

Other Name: Dual-energy X-ray absorptiometry
Procedure: audiogram

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.

Procedure: measurement of heart rate variability and baroreflex sensitivity

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.

Other Names:
  • HRV
  • BRS
Procedure: Glucose tolerance assessment

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.

Dietary Supplement: oral nutrition supplements
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).
Behavioral: Two day food records
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.
Behavioral: Food Frequency Questionnaire
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 Name: FFQ

  Hide Detailed Description

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).

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01641172

Contacts
Contact: A KL Reyners, MD, PhD +31 50 361 6161 a.k.l.reyners@umcg.nl
Contact: E GE de Vries, MD, PhD +31 50 361 6161 e.g.e.de.vries@umcg.nl

Locations
Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9713 GZ
Contact: A. KL Reyners, MD, PhD    +31 50 361 6161    a.k.l.reyners@umcg.nl   
Contact: E. GE de Vries, MD, PhD    +31 50 361 6161    e.g.e.de.vries@umcg.nl   
Principal Investigator: A. KL Reyners, MD, PhD         
Sponsors and Collaborators
University Medical Centre Groningen
Investigators
Principal Investigator: A KL Reyners, MD, PhD University Medical Centre Groningen
  More Information

No publications provided

Responsible Party: A.K.L. Reyners, MD, PhD, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01641172     History of Changes
Other Study ID Numbers: TASTY-01, NL38757.042.11
Study First Received: January 25, 2012
Last Updated: June 2, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by University Medical Centre Groningen:
taste
smell
cancer
nutrition

Additional relevant MeSH terms:
Testicular Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on July 20, 2014