Clinical trial NCT05027490: CAncer, NUtrition and Taste 2
Official title: Impact of a Nutritional, Sensory and Culinary Support on the Improvement of the Quality of Life Related to Meals in Patients With Cancer Cancer Patients Treated With Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Gynecologic Cancer
Bronchial Cancer
Breast, Gynecological or Bronchial Cancer Treated With Intravenous Chemotherapy
Keywords: cancer
nutrition
food perceptions alterations
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Although it has been established that the perception of food and eating and cooking habits change during cancer and its treatment, quality of life related to meals, which is an indicator of the psychobiological and physiological well-being of patients in their relationship to food, has been little studied in the pathological context, and particularly in patients undergoing chemotherapy.

Beyond its biological role, food plays a significant psychobiological and social role, as shown by a series of qualitative studies based on interviews with patients. Following a cancer diagnosis, loss of appetite, difficulty in sharing a meal with the family, and reduced pleasure in eating disrupt the patient's relationship with his or her food.

Thus, side effects such as fatigue, nausea and vomiting, and alterations in taste and smell induced by chemotherapy will affect patients' eating behavior, increasing the risk of deteriorating their quality of life with food. As these side effects are less known and therefore less expected by patients, they often lack the information and tools necessary to understand them.

The present study proposes a support for cancer patients treated by chemotherapy in order to improve their quality of life related to meals, and thus keep the pleasure of eating and reduce the risks of malnutrition. This support will consist of a guide provided to patients, in which they will have information on the functioning of the sensory systems involved in the eating experience, advice and culinary tips to adapt foods to their sensory disorders, and recipes that can be adapted in mild (for patients with hypersensitivity to tastes/smells), accentuated (for patients with hypersensitivity to tastes/smells) and enriched (for patients at risk of denutrition) versions. In addition, their sensory abilities will be assessed at the beginning of the study by psychophysical tests, then between each chemotherapy via a telephone interview (self-reported sensory abilities), and they will benefit from orientation according to the test results.

This work will be a first action to improve the quality of life related to the meal by information, follow-up, and adaptation of the meals to the sensory performances of each patient.


Eligibility criteria: Inclusion Criteria:

* Major patient with one of the following 3 types of cancer:

  * Stage 4 lung cancer (TNM 7 or 8). The indication for immunotherapy in addition to first line chemotherapy will not be a criterion for non-inclusion patients
  * histologically or cytologically proven localized breast cancer cytologically proven
  * Gynecological cancer (ovarian cancer or uterine cancer) stage III-IV without functional digestive signs related to the tumor disease
* Patient with a body mass index (BMI) between 18 Kg/m² and 35 Kg/m².
* Patient for whom the indication for treatment with a first line of intravenous chemotherapy (+/- targeted therapy) has been accepted by multidisciplinary meeting.
* Patient naive to previous chemotherapy.
* Life expectancy \> 3 months.
* Patient with written informed consent
* Patient affiliated to a French social security system.

Exclusion Criteria:

* Patient under 18 years
* Patient who had another malignancy within the last 3 years years, with the exception of carcinoma in situ of the cervix or cervical carcinoma in situ or adequately treated squamous cell carcinoma of the skin adequately treated, or basal cell skin cancer.This cancer must be adequately controlled.
* Patients with symptomatic brain and/or meningeal metastases.
* Patients with symptomatic mucositis.
* Patients suffering or having suffered from an ear, nose and throat disease or oeso-gastro intestinal pathology interfering with the food intake.
* Patients suffering from digestive disorders such as nausea prior to any cancer treatment.
* Indication of concomitant radiotherapy or immunotherapy treatment alone.
* Patients with a known food allergy or intolerance
* Patient with diagnosed partial or total ageusia.
* Patient with diagnosed partial or total anosmia.
* Patient having used artificial feeding in the 2 months prior to inclusion.
* Patient who has lost more than 10% of baseline weight in the 2 months prior to inclusion.
* Patient unable to be regularly followed for any reason (geographical, family, social, psychological,...).
* Patient deprived of liberty or placed under guardianship or legal protection.
* Pregnant or breastfeeding woman

Primary outcomes:
measure: QVA questionnaire score difference between the 2 arms
timeFrame: At the end of study follow-up, up to 12 weeks
Secondary outcomes:
measure: QVA questionnaire score
timeFrame: At the end of study follow-up, up to 12 weeks
measure: QLQ-C30 score
timeFrame: At the end of study follow-up, up to 12 weeks
measure: Weight
timeFrame: At the end of study follow-up, up to 12 weeks
measure: waist size
timeFrame: At the end of study follow-up, up to 12 weeks
measure: hip size
timeFrame: At the end of study follow-up, up to 12 weeks
measure: brachial circumference
timeFrame: At the end of study follow-up, up to 12 weeks
measure: Prehension strength
timeFrame: At the end of study follow-up, up to 12 weeks
measure: 24 H feedback questionnaire score
timeFrame: At the end of study follow-up, up to 12 weeks
measure: Olfactory capacities
timeFrame: At the end of study follow-up, up to 12 weeks
measure: Taste capacities
timeFrame: At the end of study follow-up, up to 12 weeks
measure: Trigeminal sensitivity
timeFrame: At the end of study follow-up, up to 12 weeks
measure: Use of CANUT guide
timeFrame: At the end of study follow-up, up to 12 weeks
measure: Patient typology
timeFrame: At the end of study follow-up, up to 12 weeks
measure: Patient satisfaction
timeFrame: At the end of study follow-up, up to 12 weeks
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Louis Pradel, Service gynécologie
city: Bron
country: France
facility: Hôpital Louis Pradel, Service pneumologie
city: Caluire-et-Cuire
country: France
facility: Infirmerie Protestante
city: Lyon
country: France
facility: Hôpital de la Croix Rousse, service pneumologie
city: Lyon
country: France
facility: Centre Léon Bérard, service gynécologie
city: Lyon
country: France
facility: Centre Léon Bérard, service pneumologie
city: Pierre-Bénite
country: France
facility: Centre hospitalo-universitaire de Lyon Sud, service Oncologie médicale
city: Pierre-Bénite
country: France
facility: Centre hospitalo-universitaire de Lyon Sud, service pneumologie
city: Saint-Étienne
country: France
facility: CHU St Etienne,
city: Valence
country: France
facility: CH de Valence
Study officials:
References: