Clinical trial NCT06058312: Individual Food Preferences for the Mediterranean Diet in Cancer Patients
Official title: Evaluation of Changes in Adherence to the Mediterranean Diet in Cancer Patients Undergoing Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neoplasms
Lead sponsor: Centre Antoine Lacassagne
Sponsor class: OTHER
Collaborators: name: University of Lyon
name: University of Firenze and Siena, Napoli, Italy
First posted: 2023-09-28
Enrollment: 442
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is an exploratory study aimed at characterizing adherence to the Mediterranean diet among patients undergoing treatment for cancer, in relation to sensory alterations that occur during treatment.

The primary strength of this project lies in the consideration of a large number of variables that scientific literature has shown to play a significant role in the dietary behavior of patients. The project's multidisciplinary approach, which takes into account both sensory perception and psychological dimensions, can enrich scientific knowledge on the subject, enabling a better understanding of the dietary behaviors of cancer patients undergoing treatment.

One of the main strengths of the project is that taste and smell reactivity will be tested using a combined approach that includes the evaluation of responses to PROP (Propylthiouracil - a bitter compound), selected aromas and odors, responses to model foods belonging to the Mediterranean diet in which the intensities of selected sensory properties are expected to be affected by chemotherapy (e.g., sweetness and freshness).

To date, no study has investigated adherence to the Mediterranean diet in such a wide range of patients. The choice of a Mediterranean diet framework is based on evidence defining this type of diet as a health promoter, improving health and preventing diseases and health complications. The Mediterranean diet includes the food variety present in the specific region chosen for the study, ensuring variety and availability of local products. The selection of the Antoine Lacassagne Center in Nice is based on the need to study the dietary preferences of a Mediterranean population familiar with Mediterranean diet products.

This project could serve as the foundation for a dietary development aspect, in which foods adapted to cancer patients will be created and tested to mitigate issues of malnutrition.

Expected Benefits Addressing the scientific question regarding the impact of sensory and psychological variables on adherence to the Mediterranean Diet and dietary behavior of cancer patients undergoing treatment will help identify individual variables to consider in assisting patients in adopting health-promoting behavior and reducing malnutrition.

Expected Risks The research project does not involve maneuvers or the implementation of care procedures other than those to which patients would be subjected if they were not participating in the study. This research involves no specific risks, except for possible risks of allergies or food intolerances related to the sensory testing session. The dietary models used only include food ingredients normally available in markets.

In order to test the taste sensitivity index, the response to propylthiouracil (PROP) will be evaluated using paper discs previously soaked in a solution composed of water and PROP according to the method of Zhao et al. (2003). This procedure has been safely used in children as well as in several studies (including patients undergoing chemotherapy) approved by ethics committees in multiple institutes from various countries.

Scientific Impact The project will provide information about the variables that impact the dietary behavior of patients undergoing chemotherapy. This knowledge will be useful in developing principles that contribute to reducing malnutrition rates in oncology patients.

Methodology This is an exploratory study aimed at characterizing adherence to the Mediterranean diet among patients with cancer undergoing treatment, who may experience changes in their relationship with food as well as their dietary behavior. Adherence to the Mediterranean diet will be studied in cancer patients at T0 (before the start of treatment) and at T1 (after 9 weeks of treatment). A comparison will be made between patients without sensory alterations and patients with taste and/or smell alterations at T1. The psychological and sensory variables impacting dietary behavior will also be measured and correlated with adherence to the Mediterranean diet and the presence or absence of sensory alterations.


Eligibility criteria: Inclusion Criteria:

* Patient aged 18-70 years old,
* Patient cared for at the Center Antoine Lacassagne (CAL) Day Hospital and needing to start chemotherapy or immunotherapy,
* Patient to return to the Antoine Lacassagne center in their 9th week of therapy,
* Patient who has not received chemotherapy or specific treatment in the 3 months prior to inclusion (wash-out period of 3 months),
* Patient having read the information note and having attested to his non-objection
* Patient not having objected to the use of this data in the context of medical research
* Patient affiliated with a Social Security scheme.

Exclusion Criteria:

* Inability to eat, or patient with enteral/parenteral nutrition,
* Patient who has undergone gastric surgery,
* Patient undergoing radiotherapy at the level of the ENT sphere (due to the possibility of affection of the mouth due to the RTH),
* Patient with cancer of the ENT sphere (upper aerodigestive tract),
* Patient with an allergy or intolerance to one of the foods offered during the sensory test sessions
* Vulnerable persons as defined in article L1121-5 to -8:
* Pregnant women, parturients and breastfeeding mothers,
* Persons deprived of their liberty by a judicial or administrative decision, persons hospitalized without consent under Articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of Article L. 1121-8,
* and persons admitted to a health or social establishment for purposes other than research,
* Adults subject to a legal protection measure or unable to express their consent.

Primary outcomes:
measure: role of sensory alterations
timeFrame: 9 weeks
Secondary outcomes:
measure: Taste perception
timeFrame: 9 weeks
measure: olfactory perception
timeFrame: 9 weeks
measure: Liking for Mediterranean-type
timeFrame: 9 weeks
measure: Perceived intensity of sensations for Mediterranean-type
timeFrame: 9 weeks
measure: Food neophobia
timeFrame: 9 weeks
measure: Dietary Quality of life
timeFrame: 9 weeks
measure: relationships to health and food attitude
timeFrame: 9 weeks
measure: Sensitivity to Reward
timeFrame: 9 weeks
measure: Sensitivity to disgust
timeFrame: 9 weeks
measure: Liking and emotions mediterranean food
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Nice
country: France
facility: Centre Antoine lacassagne
Study officials:
References: