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| Name | Class |
|---|---|
| Danone Nutricia | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| The Control Group | Patients in the control group (N=57) followed the standard hospital diet, and at outpatient basis - their usual habitual diet |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Larisa Volf, Dr | Danone Nutricia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Omsk Clinical Oncology health center | Omsk | Russia | ||||
| Mechnikov Medical University |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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 |
| Saint Petersburg |
| Russia |
| Scientific Medical center Institute of Phthisiopulmonology | Saint Petersburg | Russia |
| Smolensk region Clinical Oncology health center | Smolensk | Russia |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |