Improving Food Pleasure and Intake of Oncology Patients Receiving Chemotherapy

• Conditions: Colon Cancer; Chemotherapeutic Toxicity; Breast Cancer
• Interventions: Drug: Chemotherapy

• Registration Number: NCT04495387
• Lead Sponsor: University of Florence

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-23
• Study First Submitted QC: 2020-07-29
• Study First Posted: 2020-07-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-26
• Last Update Posted: 2021-04-27
• Study Start: 2021-07
• Primary Completion: 2022-01
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with colon cancer	Chemotherapy	-
patients with breast cancer	Chemotherapy	-

Primary Outcome Measures

Name	Time	Method
change of taste chemotherapy-related alterations	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)	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

Secondary Outcome Measures

Name	Time	Method
Emotions elicited by foods	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)	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