Taste, Smell and Chemotherapy (TASTY) - Full Text View

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 variablility and barorefelx 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:

MedlinePlus related topics: Cancer Dietary Supplements Nuclear Scans Taste and Smell Disorders Testicular Cancer

Drug Information available for: Dextrose

U.S. FDA Resources

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 2014
Estimated Primary Completion Date:	January 2014 (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 variablility and barorefelx 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 variablility and barorefelx 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

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 variablility and barorefelx 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 variablility and barorefelx 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

Show Detailed Description

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

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:	April 5, 2013
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by University Medical Centre Groningen:

tast
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 May 23, 2013