Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Patients in the study group (N=57), in addition to the usual diet, received nutritional support with the Oral Nutrition Supplement (ONS) Nutridrink Compact Protein in the amount of 2 bottles per day for 14 days prior to surgery and 14 days following surgery. During the hospital stay, additional nutritional support was added to the patient's standard hospital diet. On an outpatient basis, the patient received the required amount of ONS at his/her disposal and took it as a supplement to his/her usual and habitual diet. The ONS was recommended to be taken between main meals

Patients in the control group (N=57) followed the standard hospital diet, and at outpatient basis - their usual habitual diet

Oral Nutritional Supplement, a liquid, ready-to-drink, high protein, high calorie blend. Intended for adult patients (from 18 years of age) with malnutrition or risk of its development. Produced by Nutricia

Nutridrink Compact Protein

Larisa Volf, Dr

The study was aimed to evaluate the impact of perioperative nutritional support with high-protein mixtures on the risk of postoperative complications, postoperative recovery of respiratory functions in patients with lung cancer, nutritional status and quality of life of patients. Possible adverse events were also studied and described.

The study enrolled 114 patients with primary non-small cell lung cancer and nutritional deficiencies or at risk of developing them, admitted for surgical treatment and meeting other inclusion/exclusion criteria. Patients were randomly divided into two groups: the study group of 57 people and the control group of 57 people.

Patients in the study group, in addition to the usual diet, received nutritional support. During the hospital stay, additional nutritional support was added to the patient's standard hospital diet. On an outpatient basis, patients received the required amount at their disposal and will take it as a supplement to his usual and habitual diet.

Patients in the control group followed the standard hospital diet, and at discharge - the usual habitual diet.

The study was conducted using Enrollme.ru electronic platform. In total, the study comprised screening and 5 visits.

The Study of High-protein Nutritional Support Impact on Postoperative Outcomes in Patients With Primary Lung Cancer

Russian Multicenter Comparative Low-intervention Study of the Impact of Perioperative High-protein Nutritional Support on Postoperative Outcomes in the Treatment of Primary Lung Cancer

A test to count walk distance a patient can afford during 6 minutes

A hand strength was measured using hand dynamometer at each visit

Number of lung postoperative complications, e.g. lung infections, atelectasis were registered

Serum total protein was measured at each visit

EORTC QLQ-C30 (The European Organization for Research and Treatment of Cancer core quality of life questionnaire) questionnaire was completed at visits. The questionnaire incorporates five functional scales, three symptom scales, a global health status, and a number of single items assessing additional symptoms commonly reported by cancer patients. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale and global health status represents a high / healthy level of functioning, but a high score for a symptom scale / item represents a high level of symptomatology / problems

Danone Nutricia

Enrollme.ru, LLC

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Behaviors and Mental Disorders

Wasting Syndrome

Cachexia

Body Weight

Weight Loss

Body Weight Changes

Thinness

Quality of Life

NUTRIDRINK Compact Protein Oral nutritional supplement Dietary advice

high-energy, high-protein, oral liquid nutritional supplement; dosage: 2x125 ml per day, 7 days per week for 12 weeks (3 months)

NUTRIDRINK Compact Protein

Sylwia Malgorzewicz, MD, PhD

Determine whether nutritional support with high protein ONS in adult oncologic patients in the first step of cancer cachexia - asymptomatic precachexia, influence on the toxicity of systemic therapy.

Other endpoints:

* to determine whether high protein ONS influence on the nutritional status
* to determine whether high protein ONS influence on the quality of life
* to determine whether high protein ONS influence on the performance status
* to determine high protein ONS tolerability / ONS intake compliance

Chemotherapy-related Toxicity, Nutritional Status and Quality of Life

Chemotherapy-related Toxicity, Nutritional Status and Quality of Life in Precachectic Oncologic Patients With or Without High Protein Nutritional Support. A Prospective, Randomized Study

publication in nutritional and oncological journals, presentation on the congresses

graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 4.0); to determine whether nutritional support with high protein ONS in adult oncologic patients in the first step of cancer cachexia - asymptomatic precachexia, influence on the toxicity of systemic therapy during 3 months observation period (comparison of the results at the baseline and after 12 weeks)

the assessment according to Nutritional Risk Screening 2002 (NRS 2002), Subjective Global Assessment (SGA), body mass, body mass index (BMI), VAS for appetite, albumin, prealbumin, triglycerides, total cholesterol, fasting blood glucose, C-reactive protein (CRP), ferritin, complete blood count.

Body mass (in kg) will measure by the scales (Tanita BC 420). Hight ( in cm) measure by Stadiometer (Tanita)

Body mass index calculation (BMI) on the basis of the following formula:

BMI = body weight / height2 (kg/m2).

VAS for appetite is 100-mm line where 0 mm means "I had no appetite at all" and 100 mm means "My appetite was very good".

Laboratory parameters will measured by routine laboratory methods. All results will be compared between study groups (ONS vs without ONS) at the same time point (eg. baseline group ONS vs baseline group without ONS)

FAACT-ESPEN score Version 4 (Functional Assessment of Anorexia/Cachexia Therapy questionnaire) is a measure of the quality of life and it is completed by a patient, it has a total of 42 questions. Patients mark 0 (none) - 4 (very much) for each question. This tool consists of five subscales: functional well-being (7 items), physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items) and other aspects, including appetite (13 items).

The maximum score is 168. The lower the score, the lower overall quality of life.

To performance status assessment will be used Kornofsky scale and ECOG scale. The Karnofsky score allows to quantify the overall state and quality of life of a patient with neoplastic disease who qualifies to receive chemotherapy. The score has a range from 0 to 100, where 100 represents the ideal state and 0 - death.

The Eastern Cooperative Oncology Group(ECOG) score runs from 0 to 5, with 0 denoting perfect health and 5 death.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The Study of High-protein Nutritional Support Impact on Postoperative Outcomes in Patients With Primary Lung Cancer	NCT05710354	Lung Cancer	Nutridrink Comp...	18 Years - 69 Years	Enrollme.ru, LLC
Chemotherapy-related Toxicity, Nutritional Status and Quality of Life	NCT02848807	Toxicity Due to... Cancer Cachexia Metastatic Colo... Quality of Life Dietary Modific...	NUTRIDRINK Comp...	18 Years -	University Clinical Centre, Gdansk

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