Improving Food Pleasure and Intake of Oncology Patients Receiving Chemotherapy

Study Overview
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Brief Summary
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The global cancer burden is estimated to have risen to 18.1 million new cases in 2018 (WHO), with a trend of ongoing growth. This very frequent illness exerts tremendous physical, emotional and financial strain on individuals, families, communities and health systems. Malnutrition (under- or over-nutrition) is highly prevalent in cancer patients receiving chemotherapy and is an important predictor of morbidity, mortality, treatment response and toxicity. Alterations in taste and smell are frequently reported as side effect of chemotherapy and may contribute strongly to malnutrition and to a worsen quality of life and wellbeing social, emotional, and role functioning. There are evidences that chemotherapy influences food liking and appetite with implications for food behaviours, including food enjoyment, food preference and dietary intake. A linkage between alterations in taste and /or smell and food behaviours has been reported by some studies but not all, suggesting that there is a need for more research using common standardised methodologies and larger sample size to gain a further insight into this topic.

Official Title
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Improving Food Pleasure and Intake of Oncology Patients Receiving Chemotherapy

Conditions
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Colon Cancer, Breast Cancer, Chemotherapeutic Toxicity

Intervention / Treatment
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* Drug: Chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pathological diagnosis of colorectal or breast cacer indication to adjuvant chemotherapy for colon cancer according local guide lines indication to (neo)-adjuvant chemotherapy for reast cancer according local guide lines possiility to sign an informed consent Exclusion Criteria: patients aged <18 years patients aged >80 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with colon cancer<br> | Drug: Chemotherapy<br>* standard adjuvat chemotherapy for reast and colo cancer<br>|
| patients with breast cancer<br> | Drug: Chemotherapy<br>* standard adjuvat chemotherapy for reast and colo cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of taste chemotherapy-related alterations | To better understand alteration of taste/smell and food behaviours by the self-report responses, using an adapted version of a questionnaire set up to measure taste changes due to COVID-19 | the variables will be measured at four time points: before chemotherapy (T0), after 4 cycles (T1, each cycle is 21 days), at the end of chemotherapy (T2, 6 months from T0) and three months after the conclusion of the therapy (T3, 9 months from T0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emotions elicited by foods | Emotions elicited by foods will be measured on a selection of foods through an EmoSemio questionnaire, a self-report measure of emotion developed based on preliminary interviews | the variables will be measured at four time points: before chemotherapy (T0), after 4 cycles (T1, each cycle is 21 days), at the end of chemotherapy (T2, 6 months from T0) and three months after the conclusion of the therapy (T3, 9 months from T0) |