Improving Food Pleasure and Intake of Oncology Patients Receiving Chemotherapy

Breast Cancer Clinical Trial

Official title:

Improving Food Pleasure and Intake of Oncology Patients Receiving Chemotherapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04495387
• Other study ID #: ALTERTASTE
• Status: Not yet recruiting
• Start date: July 2021
• Est. completion date: December 2022

Study information

• Verified date: April 2021
• Source: University of Florence
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Chemotherapeutic Toxicity
• Colon Cancer
• Colonic Neoplasms

Intervention

Drug:
• Chemotherapy
standard adjuvat chemotherapy for reast and colo cancer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Florence

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)