Nutritional and Metabolic Diseases

All Conditions

Malnutrition

Nutrition Disorders

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Benzocaine

Tannic Acid

nutritional intervention with dietician at each cycle of chemotherapy in 6 first cycles to maintain 30 kcal/kg/d and 1.2 protein/kg/d

nutritional intervention with dietician plus usual nutritional care

usual nutritional care

Isabelle BOURDEL MARCHASSON, Pr.

Geneviève CHENE, Pr.

Older patients with cancer are poorly treated or not treated at all. A previous study in the south west of France (364 patients) showed that patients receiving chemotherapy had short survival times which strongly depended on nutritional status. In this study, the researchers would like to evaluate if individual dietician follow-up at each cycle of chemotherapy increases survival of patients at risk of undernutrition.

Undernutrition in patients with cancer also called tumour cachexia concerns about 50% of this population during tumour progression. It's well established that loss of weight is poor prognosis factor in patients treated by chemotherapy in digestive cancers. Small number of studies assessing undernutrition, its management and consequences on prognosis were published. Previous study lead by our team in oncogeriatry in Aquitaine accrued 364 patients more than 70 years old and treated by chemotherapy for cancer. Median follow-up at 13 months for intermediary analysis about 155 first patients revealed at first geriatric evaluation, 28 pts (18.7%) were malnourished (MNA\<17) and 72 pts (48.0%) at risk of malnutrition (MNA 17 to 23.5). At one year median follow-up major mortality was observed in 20 (71.4%) undernourished patients, 34 (47.2%) patients at risk of undernutrition and 13 (26.0%) patients without nutritional problem. According to consensus undernourished patients received nutritional support. Management of patients at risk of malnutrition is not clear. Our hypothesis is that nutritional support in patients at risk of undernutrition detected during geriatric evaluation could increase survival, safety, functional status and quality of life of patients. We construct an open multicentric two group randomized trial comparing usual nutritional management versus usual nutritional management plus nutritional intervention with dietician at each cycle of chemotherapy in 6 first cycles to maintain 30 kcal/kg/d and 1.2 protein/kg/d. Principal objective is to increase survival at 1 year with 10%. According to O'Brien and Fleming method we have to include 410 pts in each group, about 1640 pts will be evaluated by MNA test.

Nutritional Intervention in Geriatric Oncology

Nutritional Intervention in Geriatric Oncology in Patients at Risk of Undernutrition

Ministry of Health, France

Ligue contre le cancer, France

University Hospital, Bordeaux

Neoplasms

Blood and Lymph Conditions

Nervous System Diseases

Symptoms and General Pathology

Hematologic Neoplasms

Taste Disorders

Hematologic Diseases

Sensation Disorders

Neurologic Manifestations

All the patients complete the CANUT-QVA questionnaire

Evaluation of the contribution of a new questionnaire by patients with solid or hematological cancer according to 9 dimensions:

1. Making food
2. Place where the meals are eaten
3. Eating and drinking: Nutrition
4. Eating and drinking: The pleasure of tasting, chewing
5. Eating and drinking: Satiated, well being
6. Food preparation: Supply, choice, presentation
7. Eating and drinking: Feelings
8. After eating: heaviness, discomfort, hunger
9. Taste/Odour Problems to confirm the number and structure of factors obtained at the end of the pre-study and to remove redundant questions.

Evaluation of the 9 dimensions of the CANUT-QVA questionnaire

Cancer patients are at high risk of undernutrition, which is generally more pronounced for solid tumours (upper digestive tract, Ear Nose and Throat (ENT), bronchial tubes). This undernutrition leads to major weight loss and cachexia, and may represent the first sign of a call for a diagnosis of cancer. Cancer-related undernutrition is multi-factorial origins and has multiple consequences.

Chemotherapy treatments can induce various adverse effects in patients, including sensory disturbances at the beginning of treatment in addition to disturbances that may already be present before any treatment. The alteration of taste and odour, observed in 86% of patients, can induce a change in food preferences, promote the development of aversions, and therefore, lead to a significant reduction in the pleasure of eating. Loss of appetite, decreased food intake and the development of aversions to certain foods are situations experienced by a large proportion of patients treated with chemotherapy.

The assessment of taste disorders in patients treated with chemotherapy is established through the use of questionnaires, interviews and taste tests.

Changes in the perception and identification of salty, sweet, bitter and sour flavours are common in patients treated with chemotherapy.

As regards food products, patients report developing olfactory hypersensitivity mainly for food of animal origin, in particular for odours of fish, frying, cheese and eggs.

The CANUT project aims to study the effect of pathology and chemotherapy on gustatory and olfactory mechanisms, and in particular on interindividual differences in the perception and appreciation of food.

In order to monitor the evolution of patients' eating habits over time, the diet-related quality of life questionnaire (CANUT-QVA) was constructed from items selected from the Well-being related to Food questionnaire (WELLBFQ) after eliminating questions that were too general or expressed in terms of importance to use perception-related responses as a priority.

After this part, an evaluation of the 9 dimensions of the CANUT-QVA questionnaire will be performed.

CAncer, NUtrition and Taste - Validation of the CANUT-QVA Questionnaire on Eating Habits in Cancer Patients

The main evaluation criterion will be the adequacy between the responses to the food quality of life questionnaire by patients and the structure of the 9 dimensions as presented in the context (relevance of the questions for each dimension).

Hospices Civils de Lyon

Head and Neck Neoplasms

Omega 3 Fatty Acid

To assess a multimodal nutrition therapy (primary nutrition intervention+ adjuvant nutrition therapy) with features adapted for patients with cancers of the head and neck receiving chemo-radiotherapy treatment, to maintain oral dietary intake during treatment. The regimen consists of 2 medical foods, each taken on an unrestricted basis (as and when preferred by each patient).

Resource® Support Plus, a nutritionally complete Medical Food specifically for the dietary management of oncology patients with (risk of) malnutrition.

BOOST® Soothe, a Medical Food formulated as a clear oral nutritional supplement for cancer patients with sensory alterations or oral discomfort due to cancer treatments, in particular chemo- and/or radiotherapy.

In this setting patients rely on oral dietary intake. Ordinary, commercially available ingredients and food products are consumed. The standard of care includes weekly consultation with specialist oncology Registered Dietitian.

Nestlé Resource Support Plus® is a high energy- and protein-density Medical Food enriched with omega 3 polyunsaturated fatty acids. This is a nutritionally complete formula, in an easy to swallow, palatable, concentrated low volume, available in 2 flavours optimized for cancer patients undergoing chemotherapy and/or radiation in taste tests. It provides in a 125 mL serving: 250 kcal, 11.5 g protein and 0.95g of omega-3 fatty acid (eicosapentaenoic acid, EPA).

Resource® Support Plus

Vickie Baracos

The purpose of this study is to determine whether multimodal nutrition therapy (primary nutrition intervention + adjuvant nutrition therapy) will support patients to optimize their total caloric intake during cancer treatment by measuring the difference in mean cumulative energy intake between the intervention and control group over the duration of cancer treatment.

This will be an randomized, open label, parallel assignment study during cancer treatment (Baseline - Week 7 for Primary endpoint) comparing multimodal oral nutrition therapy versus standard care. Starting at Week 8, all patients receive the intervention arm until study ends at Week 14. Patients in the intervention arm continue the intervention, patients on the standard care arm cross over to the intervention (deferred nutrition intervention).

The primary objective is to assess a multimodal nutrition therapy with two Medical Foods (primary nutrition intervention+ adjuvant nutrition therapy) with features adapted for patients with cancers of the head and neck receiving chemo-radiotherapy treatment, to maintain oral dietary intake during treatment.

Randomized (multimodal oral nutrition therapy versus standard care), open label, parallel assignment, during cancer treatment (Baseline - Week 7 for Primary endpoint). Starting at Week 8, all patients receive the intervention arm until study ends at Week 14. Patients in the intervention arm continue the intervention, patients on the standard care arm cross over to the intervention (deferred nutrition intervention).

Nutritional Supplementation in Head and Neck Cancers

A Randomized Open Label Trial of Multimodal Oral Nutritional Supplementation Versus Standard Care, to Prevent / Attenuate Malnutrition in Patients With Cancers of the Head and Neck Receiving (Chemo)-Radiotherapy Treatment.

Energy intake is calculated from a one-day diet record in which the patient lists the identity and quantity of all foods and beverages consumed in the designated 24 hour time period at the end of each week (Baseline - Week 14).

Energy intake is calculated from a one-day diet record in which the patient lists the identity and quantity of all foods and beverages consumed in the designated 24 hour time period at the end of each week (Baseline - Week 14)

Change in weight (kg) from the previous week.

A sample of blood will be collected for albumin, absolute neutrophil count, lymphocyte count, C-reactive protein, standard complete blood count-differential White Blood cell count and to measure serum CRP and albumin

A survey tool for HNC patient self-assessment of the presence and degree of interference with eating, over the past 3 days, of 17 symptoms known to impact dietary intake. Scores range from 34 to 170 pts, where higher scores reflect a greater presence and interference with eating. Completed at weeks 0, 4, 7, 11, 14

A survey tool for patient self-assessment of the presence, characterization and severity of taste and smell alterations. This tool yields a 'chemosensory complaint score' of up to 16 (greatest severity of taste and smell alterations). Completed at weeks 0, 4, 7, 11, 14.

Use of pain medication will be captured weekly by a one- day pain medication log.

The volume (mL) of study products consumed will be determined from the weekly one-day diet record.

A product evaluation form for the Medical Nutrition products will be used to evaluate product overall sensory assessment, including acceptance and perception of characteristic product attributes that influence overall sensory acceptance. Medical Nutrition sensory acceptance will be evaluated by "overall liking" on the 9-point hedonic scale (1= dislike extremely; 9 = like extremely). Completed at weeks 0, 2, 4, 6, 8, 10, 12, 14.

The FAACT is a validated Quality of Life Scale to capture patient experience of cancer related cachexia - anorexia. Completed at weeks 0, 4, 7,11, 14

Protein intake is calculated from a one-day diet record in which the patient lists the identity and quantity of all foods and beverages consumed in the designated 24 hour time period at the end of each week (Baseline - Week 14)

Imaging for body composition (muscle, fat)

Review of patient medical records for instances of hospitalization with date(s) of admission falling between baseline and week 14 of study.

AHS Cancer Control Alberta

Digestive System Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

the intervention, specific to the study, is to take samples on patients with advanced gastrointestinal cancer

the intervention, specific to the study, is to take samples on non-undernourished patients supported for adjuvant chemotherapy as part of colorectal cancer

Blood samples, muscle biopsy and sample of hair

Samples

Thierry LECOMTE, MD-PhD

Undernutrition associated with cancer, or cancer cachexia results from a deterioration of the energy balance that leads to a gradual mobilization of energy reserves in the body and to increasing deterioration of the nutritional status of patients. This will thus significantly reduce quality of life and survival of patients with a lower tolerance to cancer treatments. Despite undeniable progress in knowledge, many pathophysiological mechanisms remain few or not explored, which could explain that there is still no satisfactory therapeutic solution to halt the gradual deterioration of the nutritional status of patients. In this sense, apart from preclinical data obtained in animal models, there is currently no clinical study on the functioning of skeletal muscle energy metabolism in undernourished patients suffering of cancer.

Skeletal Muscle Energy Metabolism in Undernourished Patients With Gastrointestinal Cancer

Study of Alterations in Skeletal Muscle Energy Metabolism in Undernourished Patients With Gastrointestinal Cancer

Measurement of muscle mitochondrial bioenergetics by high resolution oxygraphy

Quantification of muscle lipid droplets by electron microscopy

Analysis of the expression of target genes and proteins involved in 1/ mitochondrial metabolism 2/ lipid metabolism 3/ the regulation of energy metabolism and 4/ muscle proteolysis by RTqPCR with SYBR Green and by Western Blot

Determination of body composition ( fat mass / lean mass ) by an imaging method scannographic

Determining the isotopic composition of nitrogen hair spectrometry .

Inserm U1069 - Team Nutrition, Growth and Cancer

University Hospital, Tours

Our study population consists of oncogeriatric patients aged 70 and over, hospitalized in the oncogeriatric follow-up and referral unit (USSROG), with a diagnosis of moderate or severe undernutrition and undergoing cancer treatment. Patients will be recruited between January 1, 2022 and December 31, 2023.

We anticipate a sample size of between 100 and 120 patients over this period.

KOUADJO Blé Evelyne

PIOT-BOISSIER Claude, Dr

In France, undernutrition affects almost three million people, a third of whom are over 70 (Diagnosing undernutrition earlier in the elderly aged 70 and over, n.d.). In fact, 30 to 70% of hospitalized elderly patients suffer from protein-energy undernutrition (denutrition_personne_agee_2007_-_recommandations.pdf, n.d.).

The Nutricancer 2 study published in 2014, demonstrated that undernutrition is common among cancer patients. Indeed, 39% of patients suffer from undernutrition and its prevalence depends on the type of cancer, with a predominance of esophagus, stomach and pancreas (60% to 66%), colon/rectum, ovary/uterus and lung (39% to 45%), hematological malignancies (34%), as well as prostate and breast (13% to 20%) (Hébuterne et al., 2014). Moreover, over the past 30 years, undernutrition has been observed in 30% to 50% of the population at the time of diagnosis and before the start of cancer treatment (Boranian et al., n. d.).

Undernutrition is often associated with several terms such as malnutrition, anorexia, sarcopenia or cachexia, which refer to geriatric or metabolic syndromes of multifactorial origin that sometimes overlap, and are often observed in cancer patients. Cancer cachexia is a metabolic syndrome associated with undernutrition of multifactorial origin (Boranian et al., n.d.). Its prevalence is around 50% to 80% in cancer patients and is an independent indicator of morbidity and mortality in this population (Nicolini et al., 2013).

Undernutrition is a major health issue in elderly cancer patients. It is therefore crucial to diagnose it early, given its high prevalence in this population and the serious complications it can lead to. In 2021, the HAS updated its recommendations on the diagnosis of undernutrition in the elderly. The diagnosis of severe undernutrition is based on several criteria, including serum albumin levels. This is a commonly used marker of nutritional status, especially in patients with involuntary weight loss. However, it is important to note that hypoalbuminemia can be observed in many pathological conditions, including inflammatory syndromes common in cancer. Therefore, interpretation of albuminemia results must take into account the patient's inflammatory status, assessed by C-reactive protein. This analysis makes it possible to distinguish undernutrition due to insufficient food intake from that associated with an inflammatory syndrome and hypercatabolism (Patry \& Raynaud-Simon, 2010).

Management of Malnutrition in Oncogeriatrics

Does Targeted Management of Undernutrition in Oncogeriatric Patients Aged 70 and Over, Undergoing Cancer Treatment and Hospitalized From January 2022 to December 2023, Improve Their Nutritional and Functional Status?

the variation in albumin values associated with CRP values will be collected on admission and after the first month, at 2 months and then at 3 months of hospitalization.

These values will then be analyzed using statistical analysis software, to determine whether the results obtained are relevant and favor an improvement in albumin levels, and consequently in the patient's nutritional status.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nutritional Intervention in Geriatric Oncology	NCT00459589	Cancer Undernutrition Aging	nutritional int... usual nutrition...	70 Years -	University Hospital, Bordeaux
CAncer, NUtrition and Taste - Validation of the CANUT-QVA Questionnaire on Eating Habits in Cancer Patients	NCT04235153	Hematologic Can... Undernutrition Chemotherapy Ef... Taste Disorders Chemotherapy-In... Olfactory Disor...	Evaluation of t...	18 Years -	Hospices Civils de Lyon
Nutritional Supplementation in Head and Neck Cancers	NCT05379712	Malnourishment Nutritional Def... Undernutrition	Resource® Suppo...	18 Years -	AHS Cancer Control Alberta
Skeletal Muscle Energy Metabolism in Undernourished Patients With Gastrointestinal Cancer	NCT02573974	Undernutrition Gastrointestina...	Samples	18 Years - 80 Years	University Hospital, Tours
Nutritional Intervention in Geriatric Oncology	NCT00459589	Cancer Undernutrition Aging	nutritional int... usual nutrition...	70 Years -	University Hospital, Bordeaux
Management of Malnutrition in Oncogeriatrics	NCT06425315	Undernutrition Cancer		70 Years -	Hospices Civils de Lyon

Spots Global Cancer Trial Database for undernutrition