Lung NeoplasmsNCT07749950
Effects of Early Mobilization and Feeding After Lobectomy
A study testing Early Mobilization, Early Oral Feeding and Standard Postoperative Care in people with Lung Neoplasms, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study evaluates the effects of early mobilization and early oral feeding, two components of the Enhanced Recovery After Surgery (ERAS) protocol, on postoperative outcomes in adult patients with lung cancer undergoing lobectomy at Ege University Hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- Early Mobilization, Early Oral Feeding and Standard Postoperative Care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2026to 30 Oct 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
- Age 18 years or older
- Diagnosis or suspected diagnosis of lung cancer, including:
- Histologically or cytologically confirmed lung cancer
- Radiologically suspected lung cancer pending pathological confirmation
- Scheduled to undergo lobectomy
- Eastern Cooperative Oncology Group (ECOG) performance status of:
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- ECOG 0
- ECOG 1
- Ability and willingness to participate, including:
- Voluntary agreement to participate
- Ability to provide written informed consent
Who cannot join
- Requirement for emergency surgery
- Metastatic disease
- Severe uncontrolled comorbid disease, including:
- Cardiac failure
- Renal failure
- Hepatic failure
Show all 15Show fewer
- Requirement for mechanical ventilation for 24 hours or longer
- History of cranial trauma
- Requirement for prolonged bed rest
- Neurological conditions, including:
- Local peripheral neuropathy
- Central nervous system disease
- Impairment affecting participation, including:
- Cognitive impairment
- Communication impairment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Hospital, Department of Thoracic Surgery
Izmir, 35100
About this study
Official title: The Effect of Early Nutrition and Mobilization From ERAS Protocols on Patient Outcomes in Lung Cancer Patients Undergoing Lobectomy
This randomized controlled study evaluates the effects of early mobilization and early oral feeding, two components of the Enhanced Recovery After Surgery (ERAS) protocol, on postoperative outcomes in adult patients with lung cancer undergoing lobectomy at Ege University Hospital.
Participants were randomly assigned to an intervention group or a control group. In addition to standard postoperative care, participants in the intervention group received an ERAS-based protocol consisting of sitting at the bedside approximately 5.5 hours after surgery, beginning mobilization at 6 hours, and walking at least 100 meters when clinically stable and approved by the surgical team. Oral water intake was started at 6 hours, followed by a full liquid diet at 7 hours and gradual transition to a regular diet at 12 hours if tolerated. Participants in the control group received the clinic's standard postoperative care.
The study compares postoperative pain, complications, chest tube duration, length of hospital stay, reoperation, readmission within 30 days, nutritional status, laboratory findings, and quality of life between the two groups. Participants are followed for up to three months after surgery.
- Conditions
- Lung Neoplasms
- Being tested
- Early Mobilization, Early Oral Feeding, Standard Postoperative Care
- Keywords
- Lobectomy, Enhanced Recovery After Surgery, Early Oral Feeding, Early Mobilization, Postoperative Recovery
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early MobilizationOther
Participants who were hemodynamically stable and approved by the surgical team were seated at the bedside approximately 5.5 hours after surgery for 30 minutes. The first mobilization began at postoperative hour 6, during which participants walked at least 100 meters with appropriate assistance.
Early Oral FeedingOther
For participants who were hemodynamically stable and approved by the surgical team, oral water intake was initiated at postoperative hour 6. If no intolerance occurred, a full liquid diet was started at hour 7, followed by a gradual transition to a regular diet at hour 12.
Standard Postoperative CareOther
Participants received the clinic's routine postoperative care following lobectomy.
| Study group | Role | What they receive |
|---|---|---|
| ERAS-Based Early Mobilization and Early Oral Feeding | Experimental | Participants received the clinic's standard postoperative care plus an ERAS-based early mobilization and oral feeding protocol. When hemodynamically stable and with approval from the surgical team, participants sat at the bedside approximately 5.5 hours after surgery for 30 minutes, began mobilization at 6 hours, and walked at least 100 meters. Oral water intake began at 6 hours, followed by a full liquid diet at 7 hours and gradual transition to a regular diet at 12 hours if tolerated. Receives: Other: Early Mobilization; Other: Early Oral Feeding; Other: Standard Postoperative Care |
| Standard Postoperative Care | Active comparator | Participants received the clinic's standard postoperative care without the additional ERAS-based early mobilization and early oral feeding protocol. Routine care included postoperative monitoring, oxygen support as required, assessment of vital signs, drainage, respiratory function and pain, and coughing and breathing exercises. A liquid diet was initiated at 06:00 on the morning after surgery, and mobilization was performed according to the participant's hemodynamic condition and approval from the surgical team. Receives: Other: Standard Postoperative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest Tube Duration
The duration of chest tube placement is measured in days from the date of surgery until chest tube removal. The mean duration is compared between the experimental and control groups using hospital records.
Measured: From surgery until chest tube removal, anticipated up to 30 days
Postoperative Pain Intensity Assessed Using a Visual Analog Scale (VAS)
Pain intensity is assessed using a 100-mm Visual Analog Scale, where 0 mm indicates no pain and 100 mm indicates the worst imaginable pain. Higher scores indicate greater pain intensity. Scores are compared between the experimental and control groups at each assessment time point.
Measured: Postoperative days 1, 2, and 3; 7 days after discharge; and 1 month after discharge
Incidence and Severity of Postoperative Complications
The number and percentage of participants who develop one or more postoperative complications, including prolonged air leak lasting 7 days or more, atelectasis, pneumonia, chylothorax, atrial fibrillation, or postoperative bleeding. Complication severity is graded according to the Clavien-Dindo classification.
Measured: From surgery through 30 days after surgery
Length of Hospital Stay
Length of hospital stay is measured in days from the date of surgery until hospital discharge. The mean duration is compared between the experimental and control groups using hospital records.
Measured: From surgery until hospital discharge, anticipated up to 30 days
Secondary outcomes (5)
All-Cause Hospital Readmission Within 30 Days After Discharge
The number and percentage of participants readmitted to a hospital for any reason within 30 days after discharge are recorded. Readmission status and reason are verified using hospital records and physician assessment and compared between the experimental and control groups.
Measured: Within 30 days after hospital discharge
Unplanned Reoperation Within 30 Days After Surgery
The number and percentage of participants requiring an unplanned repeat surgical procedure due to a postoperative complication are recorded using hospital records and physician assessment. Reoperation rates are compared between the experimental and control groups.
Measured: From surgery through 30 days after surgery
Change in Quality of Life Assessed Using the EORTC QLQ-C30
Quality of life is assessed using the 30-item EORTC QLQ-C30 questionnaire. Scale scores are transformed to a range from 0 to 100. Higher global health and functional scale scores indicate better quality of life and functioning, whereas higher symptom scale scores indicate greater symptom burden. Changes from the preoperative assessment are compared between the experimental and control groups.
Measured: Preoperative baseline and 1 and 3 months after hospital discharge
Change in Lung Cancer-Specific Symptoms Assessed Using the EORTC QLQ-LC13
Lung cancer-specific symptoms and treatment-related effects are assessed using the 13-item EORTC QLQ-LC13 questionnaire. Scores are transformed to a range from 0 to 100, with higher scores indicating greater symptom burden. Changes from the preoperative assessment are compared between the experimental and control groups.
Measured: Preoperative baseline and 1 and 3 months after hospital discharge
Change in Nutritional Risk Assessed Using the NRS-2002
Nutritional risk is assessed using the Nutritional Risk Screening 2002 (NRS-2002). The total score ranges from 0 to 7, with higher scores indicating greater nutritional risk. A score of 3 or higher indicates that the participant is at nutritional risk. Changes from the preoperative score are compared between the experimental and control groups.
Measured: Preoperative baseline and 7 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start1 May 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğçe KAPLAN, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07749950
- Sponsor's protocol ID
- EGE-26-AKD-88
- Other IDs
- 26-AKD-88, 26-3/77
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Early Nutrition and Mobilization From ERAS Protocols on Patient Outcomes in Lung Cancer Patients Undergoing Lobectomy
- ClinicalTrials.gov ID
- NCT07749950
- Acronym / sponsor ID
- EGE-26-AKD-88
- Conditions
- Lung Neoplasms
- Keywords
- Lobectomy, Enhanced Recovery After Surgery, Early Oral Feeding, Early Mobilization, Postoperative Recovery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 6 Aug 2026 (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 randomized controlled study evaluates the effects of early mobilization and early oral feeding, two components of the Enhanced Recovery After Surgery (ERAS) protocol, on postoperative outcomes in adult patients with lung cancer undergoing lobectomy at Ege University Hospital.
Participants were randomly assigned to an intervention group or a control group. In addition to standard postoperative care, participants in the intervention group received an ERAS-based protocol consisting of sitting at the bedside approximately 5.5 hours after surgery, beginning mobilization at 6 hours, and walking at least 100 meters when clinically stable and approved by the surgical team. Oral water intake was started at 6 hours, followed by a full liquid diet at 7 hours and gradual transition to a regular diet at 12 hours if tolerated. Participants in the control group received the clinic's standard postoperative care.
The study compares postoperative pain, complications, chest tube duration, length of hospital stay, reoperation, readmission within 30 days, nutritional status, laboratory findings, and quality of life between the two groups. Participants are followed for up to three months after surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS-Based Early Mobilization and Early Oral Feeding | Experimental | Other: Early Mobilization, Other: Early Oral Feeding, Other: Standard Postoperative CareParticipants received the clinic's standard postoperative care plus an ERAS-based early mobilization and oral feeding protocol. When hemodynamically stable and with approval from the surgical team, participants sat at the bedside approximately 5.5 hours after surgery for 30 minutes, began mobilization at 6 hours, and walked at least 100 meters. Oral water intake began at 6 hours, followed by a full liquid diet at 7 hours and gradual transition to a regular diet at 12 hours if tolerated. |
| Standard Postoperative Care | Active comparator | Other: Standard Postoperative CareParticipants received the clinic's standard postoperative care without the additional ERAS-based early mobilization and early oral feeding protocol. Routine care included postoperative monitoring, oxygen support as required, assessment of vital signs, drainage, respiratory function and pain, and coughing and breathing exercises. A liquid diet was initiated at 06:00 on the morning after surgery, and mobilization was performed according to the participant's hemodynamic condition and approval from the surgical team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18 years or older
- Diagnosis or suspected diagnosis of lung cancer, including:
- Scheduled to undergo lobectomy
- Eastern Cooperative Oncology Group (ECOG) performance status of:
- Ability and willingness to participate, including:
Key exclusion criteria (15 listed)
- Requirement for emergency surgery
- Metastatic disease
- Severe uncontrolled comorbid disease, including:
- Requirement for mechanical ventilation for 24 hours or longer
- History of cranial trauma
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 |
|---|---|---|
| Early MobilizationParticipants who were hemodynamically stable and approved by the surgical team were seated at the bedside approximately 5.5 hours after surgery for 30 minutes. The first mobilization began at postoperative hour 6, during which participants walked at least 100 meters with appropriate assistance. | Other | ERAS-Based Early Mobilization and Early Oral Feeding |
| Early Oral FeedingFor participants who were hemodynamically stable and approved by the surgical team, oral water intake was initiated at postoperative hour 6. If no intolerance occurred, a full liquid diet was started at hour 7, followed by a gradual transition to a regular diet at hour 12. | Other | ERAS-Based Early Mobilization and Early Oral Feeding |
| Standard Postoperative CareParticipants received the clinic's routine postoperative care following lobectomy. | Other | ERAS-Based Early Mobilization and Early Oral Feeding, Standard Postoperative Care |
Primary outcome
Chest Tube Duration
Time frame: From surgery until chest tube removal, anticipated up to 30 days
The duration of chest tube placement is measured in days from the date of surgery until chest tube removal. The mean duration is compared between the experimental and control groups using hospital records.
Postoperative Pain Intensity Assessed Using a Visual Analog Scale (VAS)
Time frame: Postoperative days 1, 2, and 3; 7 days after discharge; and 1 month after discharge
Pain intensity is assessed using a 100-mm Visual Analog Scale, where 0 mm indicates no pain and 100 mm indicates the worst imaginable pain. Higher scores indicate greater pain intensity. Scores are compared between the experimental and control groups at each assessment time point.
Incidence and Severity of Postoperative Complications
Time frame: From surgery through 30 days after surgery
The number and percentage of participants who develop one or more postoperative complications, including prolonged air leak lasting 7 days or more, atelectasis, pneumonia, chylothorax, atrial fibrillation, or postoperative bleeding. Complication severity is graded according to the Clavien-Dindo classification.
Length of Hospital Stay
Time frame: From surgery until hospital discharge, anticipated up to 30 days
Length of hospital stay is measured in days from the date of surgery until hospital discharge. The mean duration is compared between the experimental and control groups using hospital records.
5 secondary outcomes
All-Cause Hospital Readmission Within 30 Days After Discharge
Time frame: Within 30 days after hospital discharge
Unplanned Reoperation Within 30 Days After Surgery
Time frame: From surgery through 30 days after surgery
Change in Quality of Life Assessed Using the EORTC QLQ-C30
Time frame: Preoperative baseline and 1 and 3 months after hospital discharge
Change in Lung Cancer-Specific Symptoms Assessed Using the EORTC QLQ-LC13
Time frame: Preoperative baseline and 1 and 3 months after hospital discharge
Change in Nutritional Risk Assessed Using the NRS-2002
Time frame: Preoperative baseline and 7 days after hospital discharge
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 7 Aug 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Mobilization, Early Oral Feeding and Standard Postoperative Care in people with Lung Neoplasms, run by Ege University at 1 site in Turkey (Türkiye).
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 11 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2026. 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 Turkey (Türkiye). 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?
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?
Chest Tube Duration (time frame: From surgery until chest tube removal, anticipated up to 30 days). The study lists 4 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 7 Aug 2026.