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

NCT05710354 | Completed

• 1 other identifier: NUTRILUNC
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 4

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Serum total protein

  during observation up to 6 weeks

• Serum albumin

  during observation up to 6 weeks

• Total lymphocyte count

  during observation up to 6 weeks

• EORTC QLQ-C30

  during observation up to 6 weeks

Study Arms (2)

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

The Control Group

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

Interventions

Nutridrink Compact Protein 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 Study Group

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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 severe uncontrolled concomitant chronic diseases and acute diseases (including infectious ones);

You may not qualify if:

• 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

Sponsors & Collaborators

• Enrollme.ru, LLC: lead
• Danone Nutricia: collaborator

Study Sites (4)

Omsk Clinical Oncology health center

Omsk, Russia

Location

Mechnikov Medical University

Saint Petersburg, Russia

Location

Scientific Medical center Institute of Phthisiopulmonology

Saint Petersburg, Russia

Location

Smolensk region Clinical Oncology health center

Smolensk, Russia

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Larisa Volf, Dr

  Danone Nutricia

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 2, 2023
• Study Start: June 1, 2022
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: February 6, 2023

Record last verified: 2023-02

Locations

RU (4)