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

NCT ID: NCT05710354

Last Updated: 2023-02-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 114 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2022-12-15

Brief Summary

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.

Detailed Description

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.

Conditions

Lung Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

The Study Group

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

Nutridrink Compact Protein

Intervention Type: DIETARY_SUPPLEMENT

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

The Control Group

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

No interventions assigned to this group

Interventions

Nutridrink Compact Protein

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Presence of morphological verification of non-small cell lung cancer (NSCLC) without distant metastases;
• Appointment of surgical treatment for primary lung cancer with anatomical resection of the lung (lobectomy, bilobectomy or pneumonectomy);
• Nutritional deficiency or risk of its development (≥3 points on the Nutrition Risk Screening 2002 (NRS-2002) scale);
• No history of nutritional support;
• ECOG (Eastern Cooperative Oncology Group Performance Status Scale) score 0 - 2;
• Life expectancy over 3 months;
• Absence of serious diseases of the gastrointestinal tract, disorders of the liver, kidneys, systemic blood diseases and metabolic disorders at the time of inclusion in the study;
• Absence of severe uncontrolled concomitant chronic diseases and acute diseases (including infectious ones);
• Availability of signed informed consent for inclusion in the study and processing of personal data

Exclusion Criteria

• Terminal state of the patient, ECOG (Eastern Cooperative Oncology Group Performance Status Scale) 3-4;
• State of refractory cachexia;
• Bleeding, serious injury or blood transfusions in the previous 6 months;
• Decay / abscess in the area of the tumor lesion;
• Presence at the same time of a tumor process of another localization, metastatic lesion of the lungs;
• The presence of concomitant diseases in the stage of decompensation;
• Pregnancy or lactation;
• Allergy to or intolerance to any of the components of Nutridrink Compact Protein, galactosemia, allergy to cow's milk proteins;
• The presence of contraindications to the use of enteral nutrition
• Participation in another study currently or in the past 30 days;
• Any other medical or non-medical reason that, in the physician's opinion, may prevent the patient from participating in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Danone Nutricia

INDUSTRY

Sponsor Role: collaborator

Enrollme.ru, LLC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Larisa Volf, Dr

Role: STUDY_DIRECTOR

Danone Nutricia

Locations

Omsk Clinical Oncology health center

Omsk, , Russia

Mechnikov Medical University

Saint Petersburg, , Russia

Scientific Medical center Institute of Phthisiopulmonology

Saint Petersburg, , Russia

Smolensk region Clinical Oncology health center

Smolensk, , Russia

Countries

Russia

Other Identifiers

NUTRILUNC

Identifier Type: -

Identifier Source: org_study_id