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Trial Title:
The Effect of Chronic Stress on Efficacy of ICIs in Esophageal Cancer Patients (STRESS-ESCA Study)
NCT ID:
NCT05967910
Condition:
Esophageal Cancer
Immunotherapy
Conditions: Official terms:
Esophageal Neoplasms
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
chronic psychological stress
Description:
Chronic psychological stress includes symptoms of anxiety and depression.
Arm group label:
Advanced esophageal cancer patients with chronic psychological stress
Arm group label:
Early esophageal cancer patients with chronic psychological stress
Summary:
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.
Criteria for eligibility:
Study pop:
200 cases of esophageal cancer patient are required and is divided into two groups: the
experimental group (stress group) and the control group (non stress group) within each
early and late stage group.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Age ≥18 years and ≤ 75 years old
2. Pathologically diagnosed as esophageal cancer
3. Patient tumor tissue samples can be obtained
4. At least one measurable lesion can be evaluated according to the RECIST 1.1 standard
5. As a newly treated patient, they have not received systematic anti-tumor treatment
for locally advanced or metastatic chest tumors
6. There is no obvious abnormality in the electrocardiogram and no obvious cardiac
dysfunction
7. Hematology and liver and kidney function indicators meet the requirements
Exclusion Criteria:
1. Merge with other malignant tumors
2. Long term use of hormones or immunosuppressants
3. Concomitant acute or chronic mental illness
4. 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
5. Other malignant diseases that require systematic treatment
6. Patients who have undergone other clinical drug experiments before
7. Patients with symptomatic brain metastases
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Oncology, The Second Xiangya Hospital, Central South University
Address:
City:
Changsha
Zip:
410011
Country:
China
Status:
Recruiting
Contact:
Last name:
Fang Wu, MD, PhD
Phone:
+86 13574858332
Email:
wufang4461@csu.edu.cn
Start date:
May 1, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Second Xiangya Hospital of Central South University
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Agency class:
Other
Collaborator:
Agency:
Changsha Central Hospital
Agency class:
Other
Source:
Second Xiangya Hospital of Central South University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05967910
