An observational study in Lung Cancer, sponsored by Enrollme.ru, LLC. Completed at 4 sites in Russian Federation. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2023-02-06.
Sponsored by Enrollme.ru, LLC · Observational
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.
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 114 is below the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Enrollme.ru, LLC is the lead sponsor of 4 studies on the registry; none are open to participants now.
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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
Exclusion Criteria:
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
Patients in the control group (N=57) followed the standard hospital diet, and at outpatient basis - their usual habitual diet
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
Weight
The weight was measured at each visit
Time frame: during observation up to 6 weeks
Days in hospital
Count of hospital stay after surgery
Time frame: during observation up to 6 weeks
Six Minute Walk Test
A test to count walk distance a patient can afford during 6 minutes
Time frame: during observation up to 6 weeks
Hand strength
A hand strength was measured using hand dynamometer at each visit
Time frame: during observation up to 6 weeks
Lung complications
Number of lung postoperative complications, e.g. lung infections, atelectasis were registered
Time frame: during hospital stay for about 2 weeks
Serum total protein
Serum total protein was measured at each visit
Time frame: during observation up to 6 weeks
Serum albumin
Serum albumin was measured at each visit
Time frame: during observation up to 6 weeks
Total lymphocyte count
Serum albumin was measured at each visit
Time frame: 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
Time frame: during observation up to 6 weeks
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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