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

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Dietary supplement: Nutridrink Compact Protein

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.

• Study Type: Observational
• Enrollment (Actual): 114

Contacts and Locations

Study Locations

• Russian Federation
  • Omsk, Russian Federation
    • Omsk Clinical Oncology health center
  • Saint Petersburg, Russian Federation
    • Mechnikov Medical University
  • Saint Petersburg, Russian Federation
    • Scientific Medical center Institute of Phthisiopulmonology
  • Smolensk, Russian Federation
    • Smolensk region Clinical Oncology health center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary lung cancer patients were enrolled in the study with or at risk of nutritional malnutrition admitted for surgery and meeting the inclusion/non-inclusion

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Dietary supplement: 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
The Control Group; Patients in the control group (N=57) followed the standard hospital diet, and at outpatient basis - their usual habitual diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	The weight was measured at each visit	during observation up to 6 weeks
Days in hospital	Count of hospital stay after surgery	during observation up to 6 weeks
Six Minute Walk Test	A test to count walk distance a patient can afford during 6 minutes	during observation up to 6 weeks
Hand strength	A hand strength was measured using hand dynamometer at each visit	during observation up to 6 weeks
Lung complications	Number of lung postoperative complications, e.g. lung infections, atelectasis were registered	during hospital stay for about 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum total protein	Serum total protein was measured at each visit	during observation up to 6 weeks
Serum albumin	Serum albumin was measured at each visit	during observation up to 6 weeks
Total lymphocyte count	Serum albumin was measured at each visit	during observation up to 6 weeks
EORTC QLQ-C30	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	during observation up to 6 weeks

Collaborators and Investigators

• Sponsor: Enrollme.ru, LLC
• Collaborators: Danone Nutricia
• Investigators: Study Director: Larisa Volf, Dr, Danone Nutricia

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2022
• Primary Completion (ACTUAL): December 15, 2022
• Study Completion (ACTUAL): December 15, 2022

Study Registration Dates

• First Submitted: January 24, 2023
• First Submitted That Met QC Criteria: January 24, 2023
• First Posted (ACTUAL): February 2, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 2, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: NUTRILUNC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No