The Effect of Chronic Stress on Efficacy of ICIs in Esophageal Cancer Patients (STRESS-ESCA Study)

Last updated: January 20, 2024
Sponsor: Second Xiangya Hospital of Central South University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Esophageal Cancer

Small Cell Lung Cancer

Esophageal Disorders

Treatment

chronic psychological stress

Clinical Study ID

NCT05967910
XYEYY2023052602
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 forlocally advanced or metastatic chest tumors
  6. There is no obvious abnormality in the electrocardiogram and no obvious cardiacdysfunction
  7. Hematology and liver and kidney function indicators meet the requirements

Exclusion

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 sympatheticnervous 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

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: chronic psychological stress
Phase:
Study Start date:
May 01, 2023
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Department of Oncology, The Second Xiangya Hospital, Central South University

    Changsha, Hunan 410011
    China

    Active - Recruiting

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