Lung CancerNCT05710354
The Study of High-protein Nutritional Support Impact on Postoperative Outcomes in Patients With Primary Lung Cancer
An observational study of Lung Cancer, run by Enrollme.ru, LLC at 4 sites in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Nutridrink Compact Protein
- Type of treatment
- Pill or oral medicine
- How many people
- 114 participants
- Where
- 4 sitesRussia
- Study dates
- 1 Jun 2022to 15 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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;
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- 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
Who cannot join
- 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;
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- 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
Trial locations and contacts
4 sites in 1 country.
Russia4 sites
Omsk Clinical Oncology health center
Omsk
Mechnikov Medical University
Saint Petersburg
Scientific Medical center Institute of Phthisiopulmonology
Saint Petersburg
Smolensk region Clinical Oncology health center
Smolensk
About this study
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
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.
Read the detailed 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.
- Conditions
- Lung Cancer
- Being tested
- Nutridrink Compact Protein
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutridrink Compact ProteinDietary 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
The weight was measured at each visit
Measured: during observation up to 6 weeks
Days in hospital
Count of hospital stay after surgery
Measured: during observation up to 6 weeks
Six Minute Walk Test
A test to count walk distance a patient can afford during 6 minutes
Measured: during observation up to 6 weeks
Hand strength
A hand strength was measured using hand dynamometer at each visit
Measured: during observation up to 6 weeks
Lung complications
Number of lung postoperative complications, e.g. lung infections, atelectasis were registered
Measured: during hospital stay for about 2 weeks
Secondary outcomes (4)
Serum total protein
Serum total protein was measured at each visit
Measured: during observation up to 6 weeks
Serum albumin
Serum albumin was measured at each visit
Measured: during observation up to 6 weeks
Total lymphocyte count
Serum albumin was measured at each visit
Measured: 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
Measured: during observation up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start1 Jun 2022
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enrollme.ru, LLC
- Sponsor type
- Research network
- Collaborators
- Danone Nutricia
- Responsible party
- Sponsor
- Investigators
- Larisa Volf, Dr, Study director, Danone Nutricia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710354
- Sponsor's protocol ID
- NUTRILUNC
- Status last verified
- Feb 2023
- First submitted
- 24 Jan 2023
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05710354
- Acronym / sponsor ID
- NUTRILUNC
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Enrollme.ru, LLCResearch network
- Collaborators
- Danone Nutricia
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Study Group | – | Dietary Supplement: Nutridrink Compact ProteinPatients 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 |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutridrink Compact ProteinOral 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 | Dietary supplement | The Study Group |
Primary outcome
Weight
Time frame: during observation up to 6 weeks
The weight was measured at each visit
Days in hospital
Time frame: during observation up to 6 weeks
Count of hospital stay after surgery
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
Hand strength
Time frame: during observation up to 6 weeks
A hand strength was measured using hand dynamometer at each visit
Lung complications
Time frame: during hospital stay for about 2 weeks
Number of lung postoperative complications, e.g. lung infections, atelectasis were registered
4 secondary outcomes
Serum total protein
Time frame: during observation up to 6 weeks
Serum albumin
Time frame: during observation up to 6 weeks
Total lymphocyte count
Time frame: during observation up to 6 weeks
EORTC QLQ-C30
Time frame: during observation up to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larisa Volf, Dr study director
Danone Nutricia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Enrollme.ru, LLC at 4 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: during observation up to 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.