Non-Small Cell Lung CancerNCT07035444
Enteral Nutrition With L-Carnitine for Cachexia in Non-Small Cell Lung Cancer
A study testing L-Carnitine 4g and Enteral Nutrition in people with Non-Small Cell Lung Cancer and Cachexia, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
This is a multicenter, double-blind randomized controlled clinical study designed to evaluate the efficacy and safety of oral nutritional supplements (ONS) containing levocarnitine for cachexia in lung cancer patients scheduled for or undergoing chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, Cachexia
- What is being tested?
- L-Carnitine 4g and Enteral Nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Primary lung tumor confirmed by cytology or histology; 2.Meeting the diagnostic criteria for cachexia (with one of the following criteria):
- Weight loss >5% in the past 6 months (without active weight loss);
- Body mass index (BMI) <20 and weight loss >2%;
- Decreased total skeletal muscle index (detected by bioelectrical impedance analysis: <7.26 kg/m² for males; <5.45 kg/m² for females) and weight loss >2%; 3.Age ≥18 years; 4.Patients scheduled to receive or currently undergoing chemotherapy; 5.Patients with an expected survival period ≥3 months; 6.Signed written informed consent and able to comply with the study visit schedule and relevant procedures; 7.Sufficient organ function before the first study treatment (no use of any blood components, leukocyte-elevating drugs, or platelet-elevating drugs within 14 days prior to randomization):
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- Absolute neutrophil count ≥1.5×10⁹/L;
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- Platelet count ≥100×10⁹/L;
- Hemoglobin >90 g/L;
- Serum creatinine <1.5×upper limit of normal (ULN) or creatinine clearance (CLcr) calculated by the Cockcroft-Gault formula >50 mL/min;
- Total bilirubin <1.5×ULN (for Gilbert syndrome patients, <3×ULN is acceptable);
- AST and ALT <2.5×ULN (for patients with liver metastases, ≤5×ULN);
- International normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤1.5×ULN, unless the subject is receiving anticoagulant therapy
Who cannot join
- 1.Patients scheduled for lung cancer surgery within the next 3 months; 2.Patients with uncontrolled hyperglycemia after adequate treatment; 3.Patients allergic to levocarnitine; 4.Patients with contraindications to enteral nutrition, including but not limited to active gastrointestinal bleeding, complete intestinal obstruction, etc.; 5.Patients with diseases severely affecting digestion and absorption, including but not limited to subtotal gastrectomy, history of intestinal surgery, etc.; 6.Patients with clinically significant cardiovascular and cerebrovascular diseases, including but not limited to:
- Myocardial infarction or unstable angina within 6 months before the first drug administration;
- Stroke or transient ischemic attack within 6 months before the first drug administration;
- Hypertension that cannot be controlled after optimal antihypertensive treatment (systolic blood pressure >160 mmHg and/or diastolic blood pressure ≥100 mmHg);
- Patients with clinically significant arrhythmia who have been stable for >14 days before the first drug administration may be enrolled;
- Congestive heart failure (New York Heart Association [NYHA] functional classification > Class 3; see Appendix VI for details);
- Myocarditis; 7.Patients currently participating in interventional clinical research treatment, or who have received other investigational drugs or devices within 4 weeks prior to randomization; 8.Active tuberculosis or tuberculosis requiring medical intervention at the current stage, including but not limited to pulmonary tuberculosis; 9.Patients with known mental illnesses or substance abuse that may affect compliance with trial requirements, or a history of alcohol abuse; 10.Patients with medical history, diseases, treatments, or laboratory abnormalities that may interfere with trial results or prevent the subject from participating in the study throughout the process, or where the investigator deems participation not in the subject's best interest; 11.Local or systemic diseases caused by non-malignant tumors, or secondary reactions to cancer, which may lead to higher medical risks and/or uncertainty in survival evaluation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hongxia xu contact
China1 site
Daping Hospital and the Research Institute of Surgery of The Third Military Medical University
Chongqing, 400042
shiqiao CHEN, 86+ 15340490583, csq-ly@tmmu.edu.cn
About this study
Official title: Enteral Nutrition Supplemented With L-Carnitine for Cachexia in Non-Small Cell Lung Cancer: A Randomized Controlled Trial
This is a multicenter, double-blind randomized controlled clinical study designed to evaluate the efficacy and safety of oral nutritional supplements (ONS) containing levocarnitine for cachexia in lung cancer patients scheduled for or undergoing chemotherapy.
Study Design:
Read more
Recruitment: Approximately 126 pathologically confirmed patients meeting the inclusion criteria will be enrolled across four hospitals (Army Characteristic Medical Center, Chongqing Fifth People's Hospital, Chongqing Thirteenth People's Hospital, and Chongqing Qianjiang District Central Hospital). The planned enrollment is 60 patients at Army Characteristic Medical Center, 22 at Chongqing Fifth People's Hospital, 22 at Chongqing Thirteenth People's Hospital, and 22 at Chongqing Qianjiang District Central Hospital.
Randomization: Patients will be randomly assigned in a 1:1 ratio to the control group (63 patients) or the intervention group (63 patients).
Interventions:
Control Group: Receive 500 mL of enteral nutrition solution daily for 12 weeks (84 days).
Intervention Group: Receive 500 mL of enteral nutrition solution containing 4 g of levocarnitine daily for 12 weeks (84 days).
Evaluations:
Efficacy Assessments: Body composition analysis and other evaluations will be conducted at baseline and after ONS treatment with levocarnitine to assess the effectiveness of the intervention.
Safety Assessments: Safety events during the levocarnitine-containing ONS treatment period and within 28 days after neoadjuvant therapy will be collected to evaluate treatment safety.
Follow-up: After chemotherapy, the investigator will determine the optimal adjuvant treatment and follow-up protocols to assess recurrence and survival outcomes.
- Conditions
- Non-Small Cell Lung Cancer, Cachexia
- Being tested
- L-Carnitine 4g, Enteral Nutrition
- Keywords
- L-carnitine, Enteral nutrition
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-Carnitine 4gDietary supplement
500ml enteral nutrition solution containing 4g of L-carnitine
Enteral NutritionDietary supplement
Enteral nutrition was given 500 ml per day for a total of 84 days.
| Study group | Role | What they receive |
|---|---|---|
| Enteral nutrition | Active comparator | During the entire study period (84 days), research participants will receive 500 ml of enteral nutrition solution daily. The nutrition is provided in two 55 g packets of nutritional powder. Each packet is dissolved in 220 ml of warm boiled water at 55°C to prepare 250 ml of the nutrition solution. Depending on the individual circumstances of the research participants, the solution can be taken in 2 to 3 divided doses daily, with a total daily volume of 500 ml. Receives: Dietary Supplement: Enteral Nutrition |
| Enteral Nutrition with L-Carnitine | Experimental | During the entire study period (84 days), research participants will receive 500 ml of enteral nutrition solution containing 4 g of L-carnitine daily. The nutrition consists of two 55 g packets of nutritional powder. Each packet is dissolved in 220 ml of warm boiled water at 55°C to make 250 ml of the nutrition solution. Depending on the individual situation of the research participants, the solution can be taken in two to three divided doses daily, with a total daily volume of 500 ml Receives: Dietary Supplement: L-Carnitine 4g |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Skeletal Muscle Mass
The total skeletal muscle mass (TSMM) is the primary endpoint of this study. It is defined as the total weight of skeletal muscles throughout the human body, typically expressed in kilograms (kg). This assessment is conducted using a body composition analyzer.
Measured: At enrollment, Day 21, Day 42, Day 63, Day 84, six months, and 12 months
Secondary outcomes (5)
BMI
The body mass index (BMI) is defined as a value obtained by dividing body weight (in kilograms) by the square of height (in meters). The formula is: weight / height²
Measured: At enrollment, Day 21, Day 42, Day 63, Day 84, six months, and 12 months
Grip strength
It is defined as the force generated by the contraction of hand muscles. This force reflects the comprehensive strength level of hand flexor muscles (such as the flexor digitorum superficialis, flexor digitorum profundus, and flexor pollicis longus) and related muscle groups (such as the thenar muscles and hypothenar muscles). To some extent, it can reflect an individual's overall muscle strength and physical function status. This assessment is measured using an electronic grip dynamometer.
Measured: At enrollment, Day 21, Day 42, Day 63, Day 84, six months, and 12 months
Inflammatory cytokines
Inflammatory molecules refer to a class of bioactive substances produced and released during the inflammatory response, which play a key role in the initiation, development, and regulation of inflammation. This assessment uses interleukin-1 (IL-1), interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), and C-reactive protein (CRP).
Measured: At enrollment, Day 21, Day 42, Day 63, Day 84, six months, and 12 months
Nutritional Score
The nutritional score is defined as a quantitative method used to assess the nutritional status of individuals or groups, and this assessment is measured using PG-SGA and NRS2002.
Measured: At enrollment, Day 21, Day 42, Day 63, Day 84, six months, and 12 months
Quality of Life Score
The quality of life score is a quantitative evaluation of the quality of life of individuals or groups, and this assessment is conducted using the EORTC QLQ-C30 C3.0 Chinese version (Quality of Life Questionnaire for Lung Cancer Patients).
Measured: At enrollment, Day 21, Day 42, Day 63, Day 84, six months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start30 Jun 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- hongxia Xu, Study director, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035444
- Sponsor's protocol ID
- ZXZYTSLC05
- Status last verified
- May 2025
- First submitted
- 5 Jun 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enteral Nutrition Supplemented With L-Carnitine for Cachexia in Non-Small Cell Lung Cancer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07035444
- Acronym / sponsor ID
- ZXZYTSLC05
- Conditions
- Non-Small Cell Lung Cancer, Cachexia
- Keywords
- L-carnitine, Enteral nutrition
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Jun 2025 (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.
This is a multicenter, double-blind randomized controlled clinical study designed to evaluate the efficacy and safety of oral nutritional supplements (ONS) containing levocarnitine for cachexia in lung cancer patients scheduled for or undergoing chemotherapy.
Study Design:
Recruitment: Approximately 126 pathologically confirmed patients meeting the inclusion criteria will be enrolled across four hospitals (Army Characteristic Medical Center, Chongqing Fifth People's Hospital, Chongqing Thirteenth People's Hospital, and Chongqing Qianjiang District Central Hospital). The planned enrollment is 60 patients at Army Characteristic Medical Center, 22 at Chongqing Fifth People's Hospital, 22 at Chongqing Thirteenth People's Hospital, and 22 at Chongqing Qianjiang District Central Hospital.
Randomization: Patients will be randomly assigned in a 1:1 ratio to the control group (63 patients) or the intervention group (63 patients).
Interventions:
Control Group: Receive 500 mL of enteral nutrition solution daily for 12 weeks (84 days).
Intervention Group: Receive 500 mL of enteral nutrition solution containing 4 g of levocarnitine daily for 12 weeks (84 days).
Evaluations:
Efficacy Assessments: Body composition analysis and other evaluations will be conducted at baseline and after ONS treatment with levocarnitine to assess the effectiveness of the intervention.
Safety Assessments: Safety events during the levocarnitine-containing ONS treatment period and within 28 days after neoadjuvant therapy will be collected to evaluate treatment safety.
Follow-up: After chemotherapy, the investigator will determine the optimal adjuvant treatment and follow-up protocols to assess recurrence and survival outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enteral nutrition | Active comparator | Dietary Supplement: Enteral NutritionDuring the entire study period (84 days), research participants will receive 500 ml of enteral nutrition solution daily. The nutrition is provided in two 55 g packets of nutritional powder. Each packet is dissolved in 220 ml of warm boiled water at 55°C to prepare 250 ml of the nutrition solution. Depending on the individual circumstances of the research participants, the solution can be taken in 2 to 3 divided doses daily, with a total daily volume of 500 ml. |
| Enteral Nutrition with L-Carnitine | Experimental | Dietary Supplement: L-Carnitine 4gDuring the entire study period (84 days), research participants will receive 500 ml of enteral nutrition solution containing 4 g of L-carnitine daily. The nutrition consists of two 55 g packets of nutritional powder. Each packet is dissolved in 220 ml of warm boiled water at 55°C to make 250 ml of the nutrition solution. Depending on the individual situation of the research participants, the solution can be taken in two to three divided doses daily, with a total daily volume of 500 ml |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 1. Primary lung tumor confirmed by cytology or histology; 2.Meeting the diagnostic criteria for cachexia (with one of the following criteria):
- <!-- -->
Key exclusion criteria (7 listed)
- 1.Patients scheduled for lung cancer surgery within the next 3 months; 2.Patients with uncontrolled hyperglycemia after adequate treatment; 3.Patients allergic to levocarnitine; 4.Patients with contraindications to enteral nutrition, including but not limited to active gastrointestinal bleeding, complete intestinal obstruction, etc.; 5.Patients with diseases severely affecting digestion and absorption, including but not limited to subtotal gastrectomy, history of intestinal surgery, etc.; 6.Patients with clinically significant cardiovascular and cerebrovascular diseases, including but not limited to:
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 |
|---|---|---|
| L-Carnitine 4g500ml enteral nutrition solution containing 4g of L-carnitine | Dietary supplement | Enteral Nutrition with L-Carnitine |
| Enteral NutritionEnteral nutrition was given 500 ml per day for a total of 84 days. | Dietary supplement | Enteral nutrition |
Primary outcome
Total Skeletal Muscle Mass
Time frame: At enrollment, Day 21, Day 42, Day 63, Day 84, six months, and 12 months
The total skeletal muscle mass (TSMM) is the primary endpoint of this study. It is defined as the total weight of skeletal muscles throughout the human body, typically expressed in kilograms (kg). This assessment is conducted using a body composition analyzer.
5 secondary outcomes
BMI
Time frame: At enrollment, Day 21, Day 42, Day 63, Day 84, six months, and 12 months
Grip strength
Time frame: At enrollment, Day 21, Day 42, Day 63, Day 84, six months, and 12 months
Inflammatory cytokines
Time frame: At enrollment, Day 21, Day 42, Day 63, Day 84, six months, and 12 months
Nutritional Score
Time frame: At enrollment, Day 21, Day 42, Day 63, Day 84, six months, and 12 months
Quality of Life Score
Time frame: At enrollment, Day 21, Day 42, Day 63, Day 84, six months, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
Hongxia xu contact
hongxia Xu study director
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-Carnitine 4g and Enteral Nutrition in people with Non-Small Cell Lung Cancer and Cachexia, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
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 12 inclusion and 7 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: opening soon, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact shiqiao CHEN (86+ 15340490583, csq-ly@tmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Skeletal Muscle Mass (time frame: At enrollment, Day 21, Day 42, Day 63, Day 84, six months, and 12 months). 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 25 Jun 2025.