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Completed

NCT Number: NCT05710354

The Study of High-protein Nutritional Support Impact on Postoperative Outcomes in Patients With 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.

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Key information

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Omsk Clinical Oncology health center, Omsk, Russia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Weight

    Time frame: during observation up to 6 weeks

    The weight was measured at each visit

  2. Days in hospital

    Time frame: during observation up to 6 weeks

    Count of hospital stay after surgery

  3. Six Minute Walk Test

    Time frame: during observation up to 6 weeks

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

  4. Hand strength

    Time frame: during observation up to 6 weeks

    A hand strength was measured using hand dynamometer at each visit

  5. Lung complications

    Time frame: during hospital stay for about 2 weeks

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

Secondary outcomes

  1. Serum total protein

    Time frame: during observation up to 6 weeks

    Serum total protein was measured at each visit

  2. Serum albumin

    Time frame: during observation up to 6 weeks

    Serum albumin was measured at each visit

  3. Total lymphocyte count

    Time frame: during observation up to 6 weeks

    Serum albumin was measured at each visit

  4. EORTC QLQ-C30

    Time frame: during observation up to 6 weeks

    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

Sponsors and collaborators

Lead sponsor

Enrollme.ru, LLC

Network

Collaborators

  • Danone Nutricia

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 2, 2023
Registry last updated
Feb 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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