Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Testicular Neoplasms

Endocrine Gland Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Endocrine System Diseases

Testicular Diseases

Gonadal Disorders

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

Patients with disseminated testicular cancer

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.

Dexa scan

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.

audiogram

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.

measurement of heart rate variability and baroreflex sensitivity

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.

Glucose tolerance assessment

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).

oral nutrition supplements

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.

Two day food records

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).

Food Frequency Questionnaire

A KL Reyners, MD, PhD

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.

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).

Taste, Smell and Chemotherapy (TASTY)

Taste and Smell Changes in Testicular Cancer Patients Treated With Cisplatin Based Chemotherapy

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.

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.

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.

To assess whether changes in taste and smell are related to the metabolic syndrome.

Tests used: glucose tolerance test and DEXA scan.

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.

University Medical Center Groningen

Mouth and Tooth Diseases

Digestive System Diseases

Ear, Nose, and Throat Diseases

Head and Neck Neoplasms

Xerostomia

Deglutition Disorders

Mucositis

Vickie Baracos, MD

The investigators hope to learn more about how side-effects of RT or RTchemo affect food intake and nutrition status.

Head and neck cancer patients often have difficulty meeting their nutritional needs while undergoing radiation therapy (RT) and/or chemotherapy (RTchemo). Tumor locations and side effects of RT or RTchemo, including dry mouth, mouth sores, difficulty chewing and swallowing, changes in taste and smell, and loss of appetite, lead to poor food intake and weight loss. The investigators hope to learn more about how side-effects of RT or RTchemo affect food intake and nutrition status.

Nutritional Status and Barriers to Dietary Intake in Head and Neck Cancer Patients

Nutritional Status and Barriers to Dietary Intake in Head and Neck Cancer Patients Prior to, on Completion of and Six Weeks After Oncology Treatment

Cross Cancer Institute

AHS Cancer Control Alberta

Nervous System Diseases

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Hearing Loss

Deafness

Hearing Disorders

Laryngeal Diseases

Ear Diseases

Otorhinolaryngologic Diseases

Sensation Disorders

Neurologic Manifestations

Respiratory Tract Diseases

Patients with head and neck conditions affecting hearing, balance, smell, taste, swallowing, voice and speech.

Marcia L Mulquin, R.N.

Joshua Levy, M.D.

Marcia Mulquin, RN, MSN

NIH Clinical Center Office of Patient Recruitment (OPR)

Background:

Many disorders of the head and neck can affect a person s hearing; balance; smell; taste; swallowing; voice; or speech. These disorders include cancers and genetic and inflammatory diseases. To find better ways to diagnose and treat these disorders, researchers need to study tissues and other biological samples from people who have them.

Objective:

To collect biological samples for a repository that will be used for research.

Eligibility:

People of any age with a disorder of the head and neck that requires the taking of biological samples. The conditions may be any that affect hearing; balance; smell; taste; swallowing; voice; or speech.

Design:

Part 1: Participants will give permission for their leftover tissue samples to be used for research. These are tissue samples from the head and neck that were collected in the course of routine tests and care or other research studies. Information on each participant s age, diagnosis, and previous treatments will also be collected.

Part 2: Some participants may be asked for more samples. All those aged 3 years or older will have a physical exam. They will provide blood and saliva samples. A cotton swab or brush will be used to collect cells from the inside of the cheek.

Participants 18 years or older may have additional tests. They may provide nasal secretions: A piece of gelfoam or a sponge will be placed in the nose to soak up secretions for 5 to 10 minutes. They may have biopsies: Small samples of tissue will be cut from the skin and the tissue lining the mouth.

Samples may be used for genetic testing.

Study Description:

National Institute on Deafness and Other Communication Disorders (NIDCD) investigators are studying the natural history and treatment of diverse conditions of the head and neck affecting hearing, balance, smell, taste, swallowing, voice and speech at the National Institutes of Health (NIH). These studies require the collection of biospecimens for research purposes.

Objectives:

Primary:

To create a biorepository of diseased and normal tissue specimens for research purposes. The samples will be obtained:

(Part 1) From surgical waste materials from participants of all ages in NIH protocols who have head and neck disorders.

(Part 2) Participants aged 3 and older may have collection of blood, saliva, and/or oral swabs. Participants aged 18 and older, may undergo oral mucosal biopsies and skin biopsies and nasal secretion collection, taken from subjects with head and neck disorders.

Secondary:

The specimens may be shared with the NCI Frederick Patient-Derived Xenograft (PDX) team, other approved protocols or may be used under this protocol to conduct analysis of cellular, molecular, genetic and genomic biology of normal processes and disorders. These laboratory studies may support development of future protocols that include new therapeutic agents, novel treatment approaches, and new prognostic and diagnostic models for subjects with disorders of the head and neck affecting human communication.

Endpoints:

The primary endpoint of this study is the creation of a head and neck biorepository from both surgical waste material and prospectively collected blood, saliva, oral swabs, oral mucosa biopsy and skin biopsy specimens.

NIDCD Otolaryngology Clinical Protocol Biospecimen Bank

(Part 1) From surgical waste materials from participants of all ages in NIH protocols who have head and neck disorders.(Part 2) Participants aged 3 and older may have collection of blood, saliva, and/or oral swabs. Participants aged 18 and older, may undergo oral mucosal biopsies and skin biopsies and nasal secretion collection, taken from subjects with head and neck disorders.

These laboratory studies may support development of future protocols that include new therapeutic agents, novel treatment approaches, and new prognostic and diagnostic models for subjects with disorders of the head and neck affecting human communication

National Institute on Deafness and Other Communication Disorders (NIDCD)

Patients with bronchial cancer will perform sensory tests before and after a 6-week period of chemotherapy.

Healthy individuals will perform sensory tests before and after a 6-week period without chemotherapy.

Perform sensory tests

The aim of the present study was to evaluate the impact of chemotherapy on sensorial perception in lung cancer patients in comparison to a control group (individuals without lung cancer and chemotherapy treatment). We will use a longitudinal approach whereby 44 patients and 44 controls will be tested for olfactory and gustatory abilities before and after treatment (for patients) and for two sessions separated by the same duration for controls. Primary measure outcome will be to examine the impact of treatment on the perception of hedonic valence of odors. Secondary measure outcome will include odor and taste perceptual changes and questionnaires on eating habits and behaviors, in order to examine the impact of treatment on odor, taste and food perception.

Sensory Approach of Food Modifications Led by Chemotherapy

Fed state This score will be evaluated before and after a 6-week period (i) of chemotherapy for patients with bronchial cancer and (ii) without chemotherapy for control subjects.

Unit of measure: A visual scale is used to collect a score from 1 (very unpleasant) to 9 (very pleasant).

This score will be evaluated before and after a 6-week period (i) of chemotherapy for patients with bronchial cancer and (ii) without chemotherapy for control subjects.

Unit of measure: A visual scale is used to collect a score from 1 (no odor) to 9 (very intense odor).

This score will be evaluated before and after a 6-week period (i) of chemotherapy for patients with bronchial cancer and (ii) without chemotherapy for control subjects.

Unit of measure: A visual scale is used to collect a score from 1 (no taste) to 9 (very intense taste).

This score will be evaluated before and after a 6-week period (i) of chemotherapy for patients with bronchial cancer and (ii) without chemotherapy for control subjects.

Unit of measure: A visual scale is used to collect a score from 1 (unknown odor) to 9 (very known odor).

This score will be evaluated before and after a 6-week period (i) of chemotherapy for patients with bronchial cancer and (ii) without chemotherapy for control subjects.

Unit of measure: A visual scale is used to collect a score from 1 (unknown taste) to 9 (very known taste).

This score will be evaluated before and after a 6-week period (i) of chemotherapy for patients with bronchial cancer and (ii) without chemotherapy for control subjects.

Unit of measure: A visual scale is used to collect a score from 1 (not edible) to 9 (very edible).

This score will be evaluated before and after a 6-week period (i) of chemotherapy for patients with bronchial cancer and (ii) without chemotherapy for control subjects.

Unit of measure: A visual scale is used to collect a score from 1 (not at all pungent) to 9 (very pungent).

This score will be evaluated before and after a 6-week period (i) of chemotherapy for patients with bronchial cancer and (ii) without chemotherapy for control subjects.

Unit of measure: A visual scale is used to collect a score from 1 (not at all warm) to 9 (very warm).

This score will be evaluated before and after a 6-week period (i) of chemotherapy for patients with bronchial cancer and (ii) without chemotherapy for control subjects.

Unit of measure: A visual scale is used to collect a score from 1 (not at all cool) to 9 (very cool).

This score will be evaluated before and after a 6-week period (i) of chemotherapy for patients with bronchial cancer and (ii) without chemotherapy for control subjects.

Unit of measure: A visual scale is used to collect a score from 1 (not at all irritant) to 9 (very irritant).

This score will be evaluated before and after a 6-week period (i) of chemotherapy for patients with bronchial cancer and (ii) without chemotherapy for control subjects.

Unit of measure: A score from 0 (no odor detected) to 16 (all odors detected) is collected.

This score will be evaluated before and after a 6-week period (i) of chemotherapy for patients with bronchial cancer and (ii) without chemotherapy for control subjects.

Unit of measure:A score from 0 (no odor identified) to 16 (all odors identified) is collected.

This score will be evaluated before and after a 6-week period (i) of chemotherapy for patients with bronchial cancer and (ii) without chemotherapy for control subjects.

Unit of measure: A score from 0 (no odor identified) to 8 (all odors identified) is collected.

This score will be evaluated before and after a 6-week period (i) of chemotherapy for patients with bronchial cancer and (ii) without chemotherapy for control subjects.

Unit of measure: a score from 0 (no taste detected) to 4 (all tastes detected) is collected.

This score will be evaluated before and after a 6-week period (i) of chemotherapy for patients with bronchial cancer and (ii) without chemotherapy for control subjects.

Unit of measure: a score from 0 (no taste identified) to 4 (all tastes identified) is collected.

This score will be evaluated before and after a 6-week period (i) of chemotherapy for patients with bronchial cancer and (ii) without chemotherapy for control subjects.

Unit of measure: A visual scale is used to collect a score from 1 (very unpleasant odor) to 9 (very pleasant odor).

This score will be evaluated before and after a 6-week period (i) of chemotherapy for patients with bronchial cancer and (ii) without chemotherapy for control subjects.

Unit of measure: A visual scale is used to collect a score from 1 (very unpleasant taste) to 9 (very pleasant taste).

Practices and food habits will be evaluated before and after the 6-week period. Food odors which appeared less or more agreeable the weeks before the survey will also be evaluated before and after the 6-week period.

Unit of measure: these measures are qualitative; the results will be expressed in percentage of given responses.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Taste, Smell and Chemotherapy (TASTY)	NCT01641172	Testicular Canc...	Dexa scan audiogram measurement of ... Glucose toleran... oral nutrition ... Two day food re... Food Frequency ...	18 Years - 50 Years	University Medical Center Groningen
Taste, Smell and Chemotherapy (TASTY)	NCT01641172	Testicular Canc...	Dexa scan audiogram measurement of ... Glucose toleran... oral nutrition ... Two day food re... Food Frequency ...	18 Years - 50 Years	University Medical Center Groningen
Nutritional Status and Barriers to Dietary Intake in Head and Neck Cancer Patients	NCT00375180	Head and Neck C...		18 Years -	AHS Cancer Control Alberta
NIDCD Otolaryngology Clinical Protocol Biospecimen Bank	NCT06303180	Hearing Loss Head and Neck N... Hearing Disorde... Laryngeal Disea...		3 Years - 99 Years	National Institutes of Health Clinical Center (CC)
NIDCD Otolaryngology Clinical Protocol Biospecimen Bank	NCT06303180	Hearing Loss Head and Neck N... Hearing Disorde... Laryngeal Disea...		3 Years - 99 Years	National Institutes of Health Clinical Center (CC)
Sensory Approach of Food Modifications Led by Chemotherapy	NCT02368509	Cancer	Perform sensory...	18 Years -	Hospices Civils de Lyon
Nutritional Status and Barriers to Dietary Intake in Head and Neck Cancer Patients	NCT00375180	Head and Neck C...		18 Years -	AHS Cancer Control Alberta

Spots Global Cancer Trial Database for taste

Every month we try and update this database with for taste cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for taste

Every month we try and update this database with for taste cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for taste cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.