NCT05967910Recruiting
The Effect of Chronic Stress on Efficacy of ICIs in Esophageal Cancer Patients (STRESS-ESCA Study)
The Effect of Chronic Stress on Efficacy of Immune Checkpoint Inhibitors in Patients With Newly Diagnosed Esophageal Cancer
Source: ClinicalTrials.gov · Last updated 23 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Chronic stress refers to a special emotional state caused by unexpected stress for a long time, with an increasing incidence in the population. It can cause the body to release hormones such as cortisol and adrenaline. Tumor patients often experience changes such as psychological and emotional abnormalities, decreased quality of life, and impaired social relationships. Under stimulation, patients often experience negative reactions such as anxiety or depression. Epidemiological studies have shown that stress can affect the prognosis of malignant tumors, but the effect of stress on the efficacy and prognosis of esophageal cancer is still unclear. In animal models, chronic stress leads to an increase in tissue catecholamine levels, increased tumor burden, and increased invasiveness of ovarian cancer cells in mouse models. At the same time, stress can promote tumor neovascularization in mice. However, the mechanism by which chronic stress affects the occurrence and development of esophageal cancer is currently unclear. In addition to neurohumoral factors, chronic stress can cause changes in the gut microbiota, which in turn affects the body's digestion, metabolism, and immune function. It is a key gatekeeper of the immune response to tumors. Therefore, gut microbiota as an intermediate factor may also affect the occurrence and prognosis of various types of esophageal cancer.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 24 May 2023
- Start date
- 1 May 2023
- Primary completion date
- 1 May 2026
- Lead sponsor
- Second Xiangya Hospital of Central South University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05967910
What you commit to
- Study type: Observational
- Planned participants: 200
- From 1 May 2023 to the primary completion date, 1 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant acute or chronic mental illness
- Patients who have been taking drugs that can alter the activity of the sympathetic nervous system for a long time or are currently taking them
- Patients who have undergone other clinical drug experiments before
Other illness
- Merge with other malignant tumors
- Other malignant diseases that require systematic treatment
Other
- Long term use of hormones or immunosuppressants
- Patients with symptomatic brain metastases
Who the study is looking for
- Age ≥18 years and ≤ 75 years old
- Pathologically diagnosed as esophageal cancer
- Patient tumor tissue samples can be obtained
- At least one measurable lesion can be evaluated according to the RECIST 1.1 standard
- As a newly treated patient, they have not received systematic anti-tumor treatment for locally advanced or metastatic chest tumors
- There is no obvious abnormality in the electrocardiogram and no obvious cardiac dysfunction
- Hematology and liver and kidney function indicators meet the requirements
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Oncology, The Second Xiangya Hospital, Central South University Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.