NCT01641172

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2012

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 16, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

3.6 years

First QC Date

January 25, 2012

Last Update Submit

April 17, 2024

Conditions

Testicular Cancer

Keywords

tastesmellcancernutrition

Outcome Measures

Primary Outcomes (1)

  • 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.

    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 Outcomes (4)

  • explore the short- and long-term consequences of taste and smell changes

    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.

  • investigate the appreciation of medical food products

    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.

  • Are changes related to metabolic syndrome?

    baseline, 1 month after start of last course, 1 year after start study; 1, 3, 5 and 7 years after chemotherapy.

  • Is chemotherapy induced neurotoxicity related to changes?

    baseline, 1 month after start of last course, 1 year after start study; 1, 3, 5 and 7 years after chemotherapy.

Study Arms (2)

Patients

ACTIVE COMPARATOR

Patients with disseminated testicular cancer

Procedure: Dexa scanProcedure: audiogramProcedure: measurement of heart rate variability and baroreflex sensitivityProcedure: Glucose tolerance assessmentDietary Supplement: oral nutrition supplementsBehavioral: Two day food recordsBehavioral: Food Frequency Questionnaire

Healthy volunteers

PLACEBO COMPARATOR

Healthy men, age 18-50 years old

Procedure: Dexa scanProcedure: audiogramProcedure: measurement of heart rate variability and baroreflex sensitivityProcedure: Glucose tolerance assessmentDietary Supplement: oral nutrition supplementsBehavioral: Two day food recordsBehavioral: Food Frequency Questionnaire

Interventions

Dexa scanPROCEDURE

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.

Also known as: Dual-energy X-ray absorptiometry
Healthy volunteersPatients
audiogramPROCEDURE

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.

Healthy volunteersPatients
measurement of heart rate variability and baroreflex sensitivityPROCEDURE

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.

Also known as: HRV, BRS
Healthy volunteersPatients
Glucose tolerance assessmentPROCEDURE

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.

Healthy volunteersPatients
oral nutrition supplementsDIETARY_SUPPLEMENT

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).

Healthy volunteersPatients
Two day food recordsBEHAVIORAL

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.

Healthy volunteersPatients
Food Frequency QuestionnaireBEHAVIORAL

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).

Also known as: FFQ
Healthy volunteersPatients

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

MeSH Terms

Conditions

Testicular NeoplasmsAnosmiaNeoplasms

Interventions

Absorptiometry, PhotonHearing

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesEndocrine System DiseasesTesticular DiseasesGonadal DisordersOlfaction DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometryChemistry Techniques, AnalyticalInvestigative TechniquesVestibulocochlear Physiological PhenomenaPhysiological PhenomenaSensationNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • A KL Reyners, MD, PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2012

First Posted

July 16, 2012

Study Start

June 1, 2012

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

April 19, 2024

Record last verified: 2024-04

Locations

NL(1)