Clinical Trials Logo

Clinical Trial Summary

Nutritional therapy is key to helping cancer patients get the nutrients they need to maintain body weight, strength, tissue and organ integrity, and face likely infections. Some cancer treatments work best when the patient is well nourished and has enough calories and macronutrients from food. According to the latest consensus, the first step in nutritional intervention is nutritional recommendations or dietary advice. These recommendations must be realized if the patient is capable of ingesting at least 75% of the nutritional requirements that correspond to them and, if there is no approach to an upcoming risk therapy. As long as the oral route is not damaged, in dietary advice this should always be the first option. Increasingly, laboratories specialized in nutritional products prepare and improve the composition of supplements. They are complete, specific and perfect to meet the dietary needs of patients who require it. But, to fulfill their function, they have to be ingested by people and for that they have to have good organoleptic characteristics, a very important nuance that is sometimes not taken into account in the manufacture of these products. It is the object of Adventia Pharma, S.L. develop new Oral Nutritional Supplements specific for cancer patients and that meet optimal organoleptic characteristics. For this reason, a pilot study will be carried out that will evaluate different sensory and organoleptic aspects of the prototypes of supplements developed by the company to determine the consumer's reaction to the products developed and subsequently be able to select the one with the greatest acceptance.


Clinical Trial Description

In cancer patients there is great difficulty in maintaining and/or improving their nutritional status if early nutritional support or surveillance measures are not taken, which can prevent progressive deterioration. The act of eating in a traditional way influences the perception of normality or illness in patients. Nutrition not only represents an essential parameter in the development of cancer, but it can also be a fundamental factor in its treatment. In the case of cancer, both the disease and the treatment have a direct impact on nutrition and generate bodily changes that gradually appear as a consequence of them. Cancer produces a direct decrease in intake, due to the disease, the metabolic alteration induced by the tumor, the physiological changes produced, the effects of cancer treatment and the presence of symptoms (depression, anorexia, vomiting, diarrhoea, pain , etc.); mechanically interfering with the normal transit of the digestive tube, or indirectly through the secretion of substances that act on peripheral receptors or on the hypothalamus. The patient may therefore be faced with a tumor cachexia syndrome characterized by weight loss, reduced fat and muscle mass, anorexia with reduced intake, early satiety, hypoalbuminemia, anemia, and progressive weakness, among others. others. This malnutrition aggravates the problem of immunosuppression that the patient already has due to his cancer, and has a great impact on functional capacity, with an increase in complications, the rate of infections, decreases tolerance to cancer treatment, the patient's quality of life and thus their chances of survival. Oral nutritional support consists of the administration of nutrients and other necessary adjuvant therapeutic substances, with the purpose of improving or maintaining the nutritional status of a patient. This support is indicated for patients who are in different clinical situations such as limitation of intake, swallowing, transit, digestion, absorption and/or metabolism of nutrients, or who have special energy and/or nutrient requirements that cannot be covered with natural food. Therefore, the main objectives of nutritional supplementation in cancer patients are the following: - Prevent or correct nutritional deficiencies. - Minimize the side effects of anti-neoplastic treatment. - Improve tolerance to anti-neoplastic treatment. - Improve Life Quality. - Help achieve optimal body weight. - Educate the patient/family about special nutritional needs. In conclusion, the choice of a nutritional supplement if it is indicated for a specific nutritional treatment should be based on its composition, its physical characteristics (taste, smell, texture...) and the underlying disease. It should also be adjusted as far as possible to the patient's tastes. There are different types of formulas, some designed with specific nutrients for certain diseases, disorders or conditions (oncology, pressure ulcers, constipation, diarrhea, etc.) and others that are intended for patients without specific needs. Increasingly, laboratories specialized in nutritional products prepare and improve the composition of supplements. They are complete, specific and perfect to meet the dietary needs of patients who require it. But, to fulfill their function, they have to be ingested by people and for that they have to have good organoleptic characteristics, a very important nuance that is sometimes not taken into account in the manufacture of these products. For this reason, a randomized, cross-sectional and double-blind pilot study was performed to evaluate different organoleptic properties of 5 oral nutritional prototype of supplements. The investigators included 30 patients. Each volunteer tasted the 5 different prototypes the same day in a different order. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05488184
Study type Interventional
Source Instituto de Investigación Hospital Universitario La Paz
Contact
Status Completed
Phase N/A
Start date June 26, 2019
Completion date June 30, 2020

See also
  Status Clinical Trial Phase
Recruiting NCT05346796 - Survivorship Plan HEalth REcord (SPHERE) Implementation Trial N/A
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Completed NCT04867850 - Effect of Behavioral Nudges on Serious Illness Conversation Documentation N/A
Enrolling by invitation NCT04086251 - Remote Electronic Patient Monitoring in Oncology Patients N/A
Completed NCT01285037 - A Study of LY2801653 in Advanced Cancer Phase 1
Completed NCT00680992 - Study of Denosumab in Subjects With Giant Cell Tumor of Bone Phase 2
Completed NCT00062842 - Study of Irinotecan on a Weekly Schedule in Children Phase 1
Active, not recruiting NCT04548063 - Consent Forms in Cancer Research: Examining the Effect of Length on Readability N/A
Completed NCT04337203 - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship N/A
Recruiting NCT04349293 - Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways N/A
Terminated NCT02866851 - Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy N/A
Active, not recruiting NCT05304988 - Development and Validation of the EFT for Adolescents With Cancer
Completed NCT00340522 - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Completed NCT03109041 - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source Phase 1
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Recruiting NCT06206785 - Resting Energy Expenditure in Palliative Cancer Patients
Recruiting NCT05318196 - Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases