A Prospective Study: the Impact of Sleep Disturbances on Immunotherapy in Patients With Lung Cancer

April 29, 2025 updated by: Shanghai Zhongshan Hospital
In recent years, immunotherapy has made significant progress in the treatment of lung cancer, especially immune checkpoint inhibitors (such as PD-1/PD-L1 antibodies) against non-small cell lung cancer (NSCLC). However, there are significant individual differences in patient response to treatment. Studies have shown that sleep disorders may affect the function of the immune system, thereby affecting tumor progression and treatment response. Therefore, the aim of this study was to evaluate the impact of sleep disturbances on lung cancer patients receiving immunotherapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Project title Association analysis between sleep disorders and tumor immunity in lung cancer: a prospective study Backgroundsleep disorders have been extensively studied in recent years and have been shown to be closely related to the development and prognosis of a variety of chronic diseases, including cancer. Especially in patients with lung cancer, sleep disorders may have an important impact on immune function, treatment response and patient survival. The changes of tumor immune microenvironment play an important role in the occurrence, development and response to immunotherapy of lung cancer. However, the relationship between sleep disorders and the tumor immune microenvironment of lung cancer has not been systematically explored. Therefore, the aim of this study was to evaluate the potential relationship between sleep disorders and tumor immunity in lung cancer and provide a new perspective for tumor immunotherapy strategies.

Aimsthe aim of this study was to evaluate the potential relationship between sleep disorders and tumor immunity in lung cancer and provide a new perspective on tumor immunotherapy strategies.

Primary outcome: Changes in tumor immune microenvironment: The effect of sleep disorders on tumor immune microenvironment was evaluated by immune cell infiltration analysis and immune marker expression level evaluation. Expression levels of immune checkpoint molecules: the changes of immune checkpoint molecules such as PD-1 and PD-L1 in tumor tissues of patients were detected.

Secondary outcomes:

The overall survival (OS) and progression-free survival (PFS) were analyzed. Biomarker changes: such as changes in the levels of cytokines (IL-6, TNF-α, etc.). Patient quality of life: The impact of sleep quality on patient general health was assessed using a standardized quality of life questionnaire.

Study DesignThis study was a single-center, prospective, observational cohort study, combining biomarker analysis with clinical follow-up.

The sample size estimate anticipated enrollment of 300 patients

Inclusion/Exclusion/Withdrawal Criteria Inclusion criteria:

Patients diagnosed with non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC).

Age: 18 to 70 years old. Patients were required to have stage I-IV disease at diagnosis and to have consented to participate in the study.

Patients had not received immunotherapy for 6 months before enrollment.

Exclusion criteria:

There were severe comorbidities (such as severe cardiovascular disease, end-stage liver and kidney disease, etc.).

Patients with psychiatric conditions or inability to complete sleep assessments.

Pregnant or lactating women. Patients who have received immunotherapy or other therapies that interfere with the immune microenvironment.

Prospective study period from July 2025 to December 2027: patient collection, outcome follow-up, data collection and analysis; January to June 2028: data analysis, paper writing July 2028 ~ December 2028: Submission of papers Statistical analysis plan Descriptive statistics: Descriptive statistical analysis was performed on the basic characteristics of patients, sleep quality scores, and immune markers.

Survival analysis: Kaplan-Meier survival curve was used to analyze the relationship between sleep quality and overall survival (OS) and progression-free survival (PFS) of lung cancer patients. log-rank test was used to compare the difference of survival time between different sleep quality groups.

Multivariate Cox regression analysis: the effect of sleep quality on immune microenvironment and survival outcome was further analyzed after adjusting for clinical covariates (such as age, gender, lung cancer stage, treatment regimen, etc.).

Immune cell infiltration analysis: The degree of immune cell infiltration in patients with different sleep quality was analyzed by immunohistochemistry and flow cytometry, and its relationship with immunotherapy response was explored.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with newly diagnosed primary lung cancer (confirmed histopathologically or cytologically) were enrolled at Zhong shan hospital fromJune 2025

Description

Inclusion Criteria:

Diagnosis of non-small-cell lung cancer (stage II-IV) Age 18 and older Immune checkpoint inhibitor therapy (e.g., nivolumab, pembrolizumab, etc.) is planned.

Be able to understand the study and provide informed consent

Exclusion Criteria:

Coexisting serious mental illness (e.g., major depression, anxiety, etc.) Recent chemotherapy or radiotherapy Other serious comorbidities (e.g., heart disease, liver and kidney insufficiency)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
lung cancer-sleep disorders
Lung cancer patients treated with PD1 immunotherapy were divided into sleep disorders and non-sleep disorders groups.
Other: PSQI
Prospective observational cohort study: Cohort o: Stratified according to baseline sleep disorder severity (PSQI score ≥7 vs. <7).
Other: PQSI
PQSI-Sleep quality assessment scale

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
pCR
Time Frame: From enrollment to the end of treatment at two years"
Pathological complete response (pCR)
From enrollment to the end of treatment at two years"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Zhongshan Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zilong Liu, Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-4-24-Prospective-SD-PD1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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