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Improving Food Pleasure and Intake of Oncology Patients Receiving Chemotherapy

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ClinicalTrials.gov Identifier: NCT04495387
Recruitment Status : Not yet recruiting
First Posted : July 31, 2020
Last Update Posted : July 31, 2020
Sponsor:
Information provided by (Responsible Party):
Giandomenico Roviello, 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.


Condition or disease Intervention/treatment
Colon Cancer Breast Cancer Chemotherapeutic Toxicity Drug: Chemotherapy

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improving Food Pleasure and Intake of Oncology Patients Receiving Chemotherapy
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
patients with colon cancer Drug: Chemotherapy
standard adjuvat chemotherapy for reast and colo cancer

patients with breast cancer Drug: Chemotherapy
standard adjuvat chemotherapy for reast and colo cancer




Primary Outcome Measures :
  1. change of taste chemotherapy-related alterations [ Time Frame: 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 :
  1. Emotions elicited by foods [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
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Responsible Party: Giandomenico Roviello, Assistant professor, md, phd, University of Florence
ClinicalTrials.gov Identifier: NCT04495387    
Other Study ID Numbers: ALTERTASTE
First Posted: July 31, 2020    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases