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

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Breast Neoplasms

Weight Loss

Body Weight

Breast Diseases

Skin Diseases

Body Weight Changes

subjects participate diet, exercise and mindfulness programs

subjects participate diet and exercise programs

Participants will attend 8-week online dietary course. In addition to weekly classes, participants are required to photograph each meal.

Dietary program

Everyday walking steps more than 4000 steps. To accurately track participants' daily step counts, the research team provided quailfied pedometers.

Exercise program

Participants will attend 8-week online mindfulness course. In addition to weekly classes, participants practiced mindfulness individually for 5 minutes each day and maintained a mindfulness diary.

Mindfulness program

I-Ching Hou

Yi-Fung Lin

Associate Professor

The study addresses the pressing issue of overweight and obesity among breast cancer patients, which exacerbates recurrence rates and mortality risks. Its primary objective is to assess the efficacy of two intervention models, the Diet, Exercise, and Mindfulness (DEM) model and the Diet and Exercise (DE) model, in facilitating weight loss, enhancing self-efficacy, mindfulness, and quality of life. The anticipated outcomes include long-term engagement in online self-learning, overcoming the limitations of ineffective self-management learning, and empowering healthcare professionals with scenario-based teaching materials. Through online platforms, patients can learn and review without constraints, ultimately achieving a holistic balance among physical, mental, and spiritual health.

\[Research Background\] Breast cancer ranks first among cancers in women worldwide, with overweight and obesity being one of the high-risk factors for breast cancer. Moreover, overweight individuals within the breast cancer patient population also face higher recurrence rates and mortality risks. Assisting overweight or obese breast cancer women in weight loss to promote their well-being was the initial idea behind this study. The most common weight loss strategies include dietary management and regular exercise. In recent years, more studies have shown that effective weight loss also requires psychological interventions. Therefore, this study will combine dietary, exercise, and mindfulness-related interventions to assist breast cancer patients in more effective weight management.

\[Research Objectives\] To compare the effectiveness of two intervention measures, the Diet, Exercise, and Mindfulness (DEM) model and the Diet and Exercise (DE) model, on weight loss, self-efficacy, mindfulness tendency, and quality of life.

\[Research Method\] The study will involve a quantitative study, which plans to carry out a randomized controlled trial (RCT). This trial will compare the effects of two intervention measures, the DEM model and the DE model, on weight loss, self-efficacy, mindfulness tendency, and quality of life.

\[Expected Results\] Through the intervention provided by this study, patients can engage in long-term online self-learning and supplementary learning after returning home, reducing the limitations of ineffective self-management learning caused by negative emotions, treatment side effects, and sequelae in the early stages of cancer. Healthcare professionals can also use scenario-based teaching materials produced by this study to guide breast cancer survivors with ineffective weight self-management skills in practicing the necessary skills. Additionally, through online learning, patients can learn and review without pressure, saving time on transportation, easing carbon foot print and relearning effective weight management skills; even if they have faced major life threats in the past, they can turn adversity into blessings, achieving a balance among physical, mental, and spiritual health.

Effectiveness of a Combined Diet and Mindfulness Program on Weight Loss in Breast Cancer Survivors

Effectiveness of a Combined Diet and Mindfulness Program on Weight Loss in Breast Cancer Survivors: A Randomized Controlled Trial

BMI in kg/m2 (weight in kilograms divided by height in meters squared)

The minimum value is 1 and maximum value is 6, and higher scores mean a better outcome.

The minimum value is 0 and maximum value is 10, and higher scores mean a better outcome.

1. Item 1 to 28 the minimum value is 1 and maximum value is 4, and lower scores mean a better outcome.
2. Item 29 to 30 the minimum value is 1 and maximum value is 7, and higher scores mean a better outcome.

The minimum value is 1 and maximum value is 4, and lower scores mean a better outcome.

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
Effectiveness of a Combined Diet and Mindfulness Program on Weight Loss in Breast Cancer Survivors	NCT06427473	Breast Cancer Weight Loss	Dietary program Exercise progra... Mindfulness pro...	20 Years - 65 Years	National Yang Ming Chiao Tung University

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