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Completed

NCT Number: NCT05027490

CAncer, NUtrition and Taste 2

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Breast, Gynecological or Bronchial Cancer Treated With Intravenous Chemotherapy Bronchial Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Gynecologic Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Louis Pradel, Service gynécologie, Bron, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CANUT support

Other

CANUT support includes delivery of the CANUT guide (food guide developed by Paul Bocuse Institute from previous results) ; it will be given to patient with explanations about the use of the guide. This also includes 2 calls from a dietician, performed between the 1st and the 3rd chemotherapy cycle to help patient personally with their food side effects.

Anthropometric measures

Other

These measures include weight, waist size, hip size and brachial circumference

Prehension strength measurement

Other

Prehension strength will be assessed thanks to a hand grip device, that makes it possible to measure strength of all fingers, hands, wrists and forearms muscles

QVA Questionnaire

Behavioral

Food quality of life questionnaire

QLQ C30 Questionnaire

Behavioral

Quality of Life questionnaire Core 30

Scratch & Snif Test

Behavioral

The Scratch & Snif Test is used to assess olfactory capacities : patient has to scratch a box on a card, smell it and recognize the scent amongst a list of propositions

Taste Strip Test

Behavioral

The Taste Strip Test is used to assess taste capacities : strips impregnated with different concentrations of the 5 basic taste qualities (sweet, sour, acid, bitter, umami) are successively placed on patient's tongue ; patient has to identify the taste bit by bit.

24 H feed back questionnaire

Behavioral

This questionnaire describes patient's food and drink intakes during the last 24 ours

Condiment questionnaire

Behavioral

This questionnaire used to assess condiments consumption

Tobacco questionnaire

Behavioral

This questionnaire used to assess tobacco consumption

Nutrition interview

Other

This interview will be conducted by a dietician

Primary outcomes

  1. QVA questionnaire score difference between the 2 arms

    Time frame: At the end of study follow-up, up to 12 weeks

    The main endpoint of CANUT-2 is the comparison of the overall score of the food quality of life questionnaire (Qualité de Vie Alimentaire QVA) between patients who received CANUT support and those who did not receive the CANUT support. The comparison is performed at the time of V2 i.e. after 4 cycles of chemotherapy treatment, corresponding with the end of study follow-up.

Secondary outcomes

  1. QVA questionnaire score

    Time frame: At the end of study follow-up, up to 12 weeks

    Food questionnaire score QVA will be compared for each subsection between the 2 groups and between V1 (inclusion) and V2 (after 4 cycles of chemotherapy), according to the type of cancer.

  2. QLQ-C30 score

    Time frame: At the end of study follow-up, up to 12 weeks

    Quality of life questionnaire score QLQ-C30 will be compared between the 2 arms and between V1 and V2, according to the type of cancer

  3. Weight

    Time frame: At the end of study follow-up, up to 12 weeks

    Anthropometric parameters (weight, waist size, hip size and brachial circumference) associated with 24 H feedback questionnaire score and prehension strength, will make it possible to assess evolution of nutritional status between the 2 arms and between V1 and V2, according to the type of cancer.

  4. waist size

    Time frame: At the end of study follow-up, up to 12 weeks

    Anthropometric parameters (weight, waist size, hip size and brachial circumference) associated with 24 H feedback questionnaire score and prehension strength, will make it possible to assess evolution of nutritional status between the 2 arms and between V1 and V2, according to the type of cancer.

  5. hip size

    Time frame: At the end of study follow-up, up to 12 weeks

    Anthropometric parameters (weight, waist size, hip size and brachial circumference) associated with 24 H feedback questionnaire score and prehension strength, will make it possible to assess evolution of nutritional status between the 2 arms and between V1 and V2, according to the type of cancer.

  6. brachial circumference

    Time frame: At the end of study follow-up, up to 12 weeks

    Anthropometric parameters (weight, waist size, hip size and brachial circumference) associated with 24 H feedback questionnaire score and prehension strength, will make it possible to assess evolution of nutritional status between the 2 arms and between V1 and V2, according to the type of cancer.

  7. Prehension strength

    Time frame: At the end of study follow-up, up to 12 weeks

    This parameter, associated with anthropometric parameters and 24 H feedback questionnaire score, will make it possible to assess evolution of nutritional status between the 2 arms and between V1 and V2, according to the type of cancer

  8. 24 H feedback questionnaire score

    Time frame: At the end of study follow-up, up to 12 weeks

    This parameter, associated with anthropometric parameters and prehension strength, will make it possible to assess evolution of nutritional status between the 2 arms and between V1 and V2, according to the type of cancer

  9. Olfactory capacities

    Time frame: At the end of study follow-up, up to 12 weeks

    Olfactory capacities will be assessed thanks to the Scratch & Snif Test

  10. Taste capacities

    Time frame: At the end of study follow-up, up to 12 weeks

    Taste capacities will be assessed thanks to the Taste Strip Test

  11. Trigeminal sensitivity

    Time frame: At the end of study follow-up, up to 12 weeks

    Trigeminal sensitivity will be assessed thanks to a trigeminal sensitivity test

  12. Use of CANUT guide

    Time frame: At the end of study follow-up, up to 12 weeks

    Changes in the frequency of use of the CANUT guide

  13. Patient typology

    Time frame: At the end of study follow-up, up to 12 weeks

    Determining patient typology according to CITAS (Chemotherapy-induced Taste Alteration Scale) scale

  14. Patient satisfaction

    Time frame: At the end of study follow-up, up to 12 weeks

    Determining patient satisfaction using a satisfaction questionnaire

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study 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

Acronym: CANUT-2

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 30, 2021
Registry last updated
Oct 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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