Esophageal CancerSTRESS-ESCANCT05967910
The Effect of Chronic Stress on Efficacy of ICIs in Esophageal Cancer Patients (STRESS-ESCA Study)
An observational study of Esophageal Cancer and Immunotherapy, run by Second Xiangya Hospital of Central South University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer, Immunotherapy
- What is being tested?
- chronic psychological stress
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 31 Dec 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Merge with other malignant tumors
- Long term use of hormones or immunosuppressants
- 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
- Other malignant diseases that require systematic treatment
- Patients who have undergone other clinical drug experiments before
- Patients with symptomatic brain metastases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Oncology, The Second Xiangya Hospital, Central South University
Changsha, Hunan, 410011
Fang Wu, MD, PhD, +86 13574858332, wufang4461@csu.edu.cn
About this study
Official title: The Effect of Chronic Stress on Efficacy of Immune Checkpoint Inhibitors in Patients With Newly Diagnosed Esophageal Cancer
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.
- Conditions
- Esophageal Cancer, Immunotherapy
- Being tested
- chronic psychological stress
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chronic psychological stressOther
Chronic psychological stress includes symptoms of anxiety and depression.
| Study group | Role | What they receive |
|---|---|---|
| Early esophageal cancer patients with chronic psychological stress | Not described Receives: Other: chronic psychological stress | |
| Early esophageal cancer patients without chronic psychological stress | Not described | |
| Advanced esophageal cancer patients with chronic psychological stress | Not described Receives: Other: chronic psychological stress | |
| Advanced esophageal cancer patients without chronic psychological stress | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
The proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Measured: 3 years
Progression-free survival (PFS)
Time from the beginning of first-line immunotherapy to the first progression(PD) in patients with advanced esophageal cancer
Measured: 3 years
Effect of Chronic stress on efficacy of immune checkpoint inhibitors
The chronic stress status including depression and anxiety symptoms.We will use two types of questionnaires, Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7), as a whole to conduct a comprehensive psychological assessment of patients. And then evaluate the impact of chronic stress status on the efficacy of immune checkpoint inhibitors, including ORR, PFS, and OS.
PHQ-9 has 9 items, each on a scale of 0 to 3. The sum score (range 0 to 27) indicates the degree of depression, with scores of 5, 10, 15, and 20 represent mild, moderate, moderate to severe and severe levels of depression.
GAD-7 has 7 items, each on a scale of 0 to 3. Higher total scores (ranging from 0 to 21) indicate higher anxious symptoms with 5 to 9 classified as mild, 10 to 14 classified as moderate, and 15 to 21 classified as moderate-severe.
Measured: 3 years
Secondary outcomes (2)
Overall survival (OS)
Overall survival (OS) is defined as the duration from the beginning of first-line immunotherapy until death due to any cause. Subjects who are still alive at the end of the study observation period will be censored at the time of last known vital status.
Measured: 5 years
Effect of chronic stress on quality of life
Chronic stress status including depression and anxiety symptoms.We will use Short Form Health Survey 36 (SF-36) and EORTC QLQ-C30 (version. 3) questionnaires as a whole to evaluate the quality of life of patients.
SF-36 includes 36 items and assesses the functional status and well-being on eight multi-item subscales. The total score on each SF-36 subscale ranges between 0 and 100. A greater score indicates better QoL.
The EORTC QLQ-C30 is composed of 9 multi-item scales: 5 functioning scales (physical, role, cognitive, emotional, and social), a global QOL scale, and 3 symptom scales (fatigue, pain, and nausea/vomiting). All scales and single items are linearly transformed to an 0-100 scale. A higher score represents a better level of functioning.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 May 2023
- Primary completion1 May 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Second Xiangya Hospital of Central South 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Changsha Central Hospital
- Responsible party
- Principal investigator, Fang Wu, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967910
- Sponsor's protocol ID
- XYEYY2023052602
- Acronym
- STRESS-ESCA
- Status last verified
- Jan 2024
- First submitted
- 24 May 2023
- Last updated
- 23 Jan 2024
- Results posted
- 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 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chronic Stress on Efficacy of Immune Checkpoint Inhibitors in Patients With Newly Diagnosed Esophageal Cancer
- ClinicalTrials.gov ID
- NCT05967910
- Acronym / sponsor ID
- STRESS-ESCA / XYEYY2023052602
- Conditions
- Esophageal Cancer, Immunotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Changsha Central Hospital
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Aug 2023 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Early esophageal cancer patients with chronic psychological stress | – | Other: chronic psychological stress |
| Early esophageal cancer patients without chronic psychological stress | – | – |
| Advanced esophageal cancer patients with chronic psychological stress | – | Other: chronic psychological stress |
| Advanced esophageal cancer patients without chronic psychological stress | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- Merge with other malignant tumors
- Long term use of hormones or immunosuppressants
- 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
- Other malignant diseases that require systematic treatment
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 |
|---|---|---|
| chronic psychological stressChronic psychological stress includes symptoms of anxiety and depression. | Other | Advanced esophageal cancer patients with chronic psychological stress, Early esophageal cancer patients with chronic psychological stress |
Primary outcome
Objective Response Rate (ORR)
Time frame: 3 years
The proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Progression-free survival (PFS)
Time frame: 3 years
Time from the beginning of first-line immunotherapy to the first progression(PD) in patients with advanced esophageal cancer
Effect of Chronic stress on efficacy of immune checkpoint inhibitors
Time frame: 3 years
The chronic stress status including depression and anxiety symptoms.We will use two types of questionnaires, Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7), as a whole to conduct a comprehensive psychological assessment of patients. And then evaluate the impact of chronic stress status on the efficacy of immune checkpoint inhibitors, including ORR, PFS, and OS. PHQ-9 has 9 items, each on a scale of 0 to 3. The sum score (range 0 to 27) indicates the degree of depression, with scores of 5, 10, 15, and 20 represent mild, moderate, moderate to severe and severe levels of depression. GAD-7 has 7 items, each on a scale of 0 to 3. Higher total scores (ranging from 0 to 21) indicate higher anxious symptoms with 5 to 9 classified as mild, 10 to 14 classified as moderate, and 15 to 21 classified as moderate-severe.
2 secondary outcomes
Overall survival (OS)
Time frame: 5 years
Effect of chronic stress on quality of life
Time frame: 5 years
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 23 Jan 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer and Immunotherapy, run by Second Xiangya Hospital of Central South University at 1 site in China.
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 7 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 23 Jan 2024. 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 China. 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?
Contact Fang Wu, MD.PhD (+86 135744858332, wufang4461@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: 3 years). The study lists 3 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 23 Jan 2024.