- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04936750
A One-arm, Prospective Study Comparing the Effects of Different Body Composition on the Survival of Patients Undergoing Radical Concurrent Chemoradiotherapy for Esophageal Cancer
April 13, 2023 updated by: Tianjin Medical University Cancer Institute and Hospital
Skeletal muscle depletion and sarcopenia are the most typical features of cachexia, which occurs in 80% of patients with advanced esophageal cancer.
Skeletal muscle consumption is an independent factor for poor prognosis, which negatively affects therapeutic toxicity, length of hospital stay, quality of life, complications, infection, and survival.
The vast majority of patients had already experienced severe weight loss and skeletal muscle loss before the treatment began.
During the concurrent chemoradiotherapy period, the intensity and long cycle of treatment, the toxic and side effects of treatment and the occurrence of radiation esophagitis would further lead to the increased demand for energy and decreased intake of patients, thus leading to continuous weight loss.
Based on the previous literature, we suggest that baseline body composition has a significant impact on nutritional status, the incidence of adverse reactions, and survival during treatment.
This research mainly for the thorough chemoradiation in patients with esophageal cancer, analysis treatment precursor composition, including skeletal muscle index, visceral fat area, body fat percentage and other parameters on the side reaction of chemoradiation, nutritional status and the influence of survival, and observe the baseline body composition and cure after 1 month of body composition changes of the impact on the survival time.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
120
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
- Name: Qingsong Pang, Dr
- Phone Number: 18622221203
- Email: pangqingsong@tjmuch.com
Study Locations
-
-
-
Tianjin, China
- Recruiting
- Tianjin Medical University Cancer Institute and Hospital/
-
Contact:
- Qingsong Pang, Dr
- Phone Number: 022-23340123
- Email: pangqingsong@tjmuch.com
-
-
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
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients with esophageal cancer receiving radical concurrent chemoradiotherapy with or without PD1 antibodies
Description
Inclusion Criteria:
- Voluntary participation and face to face signed informed consent;
- 18 -- 75 years old, gender unlimited;
- The histological diagnosis was esophageal squamous cell carcinoma, and the clinical staging was stage II-IVA (according to AJCC stage 8, pre-treatment clinical staging was: CT1N2-3M0, CT2-4BN0-3M0).
- Initial treatment patients receiving radical concurrent chemoradiotherapy; Immunotherapy with or without combination;
- The primary tumor can be evaluated;
- No distant metastasis;
- No serious abnormal function of blood system, heart, lung, liver and kidney or immune deficiency;
- Hemoglobin (Hb) ≥9 g/dL; White blood cell (WBC) ≥3×109/L; Neutrophils (ANC)≥1.5×109/L; Platelet (PT)≥100×109/L;
- Bilirubin < 1.5 times the upper limit of normal; Alanine aminotransferase (ALT) and alanine aminotransferase (AST) ≤2.5 times the upper limit of normal;
- Serum creatinine ≤1.5 times the upper limit of normal value;
- The willingness of men or women of reproductive age to use contraception in the trial;
- Physical condition score ECOG 0 ~ 2;
- The expected survival time was >3 months.
Exclusion Criteria:
- Patients who lacked an evaluation of CT body composition within 15 days prior to treatment initiation;
- Patients with severe intestinal function damage or inability to tolerate intestinal nutrition;
- The digestive tract is severely obstructed, unable to take food orally and unable/unwilling to undergo nasogastric tube or percutaneous gastrostomy;
- Previous surgery, chemoradiotherapy or bio-targeted therapy for esophageal cancer;
- Previous history of malignant tumor.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall survival
Time Frame: one month
|
To evaluate the effect of human components on the overall survival of patients with esophageal cancer undergoing radical concurrent chemoradiotherapy
|
one month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
June 17, 2021
Primary Completion (Anticipated)
March 1, 2024
Study Completion (Anticipated)
December 1, 2024
Study Registration Dates
First Submitted
June 16, 2021
First Submitted That Met QC Criteria
June 22, 2021
First Posted (Actual)
June 23, 2021
Study Record Updates
Last Update Posted (Actual)
April 14, 2023
Last Update Submitted That Met QC Criteria
April 13, 2023
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LX202104022
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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