Clinical trial NCT04495387: Improving Food Pleasure and Intake of Oncology Patients Receiving Chemotherapy
Official title: Improving Food Pleasure and Intake of Oncology Patients Receiving Chemotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colon Cancer
Breast Cancer
Chemotherapeutic Toxicity
Lead sponsor: University of Florence
Sponsor class: OTHER
First posted: 2020-07-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data will be collected on patients that are receiving chemotherapy for breast (n=50) and colorectal cancer (n=50) as adjuvant or neo-adjuvant therapy.

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.


Eligibility criteria: 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

Primary outcomes:
measure: change of taste chemotherapy-related alterations
timeFrame: 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 outcomes:
measure: Emotions elicited by foods
timeFrame: 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)
Other outcomes:
Locations:
Study officials:
References:
citation: Spinelli S, Mini E, Monteleone E, Angiolini C, Roviello G. ALTERTASTE: improving food pleasure and intake of oncology patients receiving chemotherapy. Future Oncol. 2021 Jul;17(20):2573-2579. doi: 10.2217/fon-2020-0871. Epub 2021 Apr 16.