Improving Food Pleasure and Intake of Oncology Patients Receiving Chemotherapy

NCT04495387 | Unknown

• 1 other identifier: ALTERTASTE
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colon Cancer; Breast Cancer; Chemotherapeutic Toxicity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (2)

patients with colon cancer

Drug: Chemotherapy

patients with breast cancer

Drug: Chemotherapy

Interventions

Chemotherapy DRUG

standard adjuvat chemotherapy for reast and colo cancer

patients with breast cancer; patients with colon cancer

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• patients aged \<18 years
• patients aged \>80 years

Sponsors & Collaborators

• University of Florence: lead

Related Publications (1)

• 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.

  PMID: 33858202 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms; Breast Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor, md, phd

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: July 31, 2020
• Study Start: July 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR