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

Lung Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05710354
• Other study ID #: NUTRILUNC
• Status: Completed
• Start date: June 1, 2022
• Est. completion date: December 15, 2022

Study information

• Verified date: February 2023
• Source: Enrollme.ru, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: December 15, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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

Locations

Country	Name	City	State
Russian Federation	Omsk Clinical Oncology health center	Omsk
Russian Federation	Mechnikov Medical University	Saint Petersburg
Russian Federation	Scientific Medical center Institute of Phthisiopulmonology	Saint Petersburg
Russian Federation	Smolensk region Clinical Oncology health center	Smolensk

Sponsors (2)

Lead Sponsor	Collaborator
Enrollme.ru, LLC	Danone Nutricia

Country where clinical trial is conducted

Russian Federation, 

Outcome

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