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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
trial testing Analysis of body composition in Brief Description of Focus of Study in 120 participants. Status unknown.
1 March 2024
Quick facts
| Lead sponsor | Tianjin Medical University Cancer Institute and Hospital |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 120 |
| Start date | 17 June 2021 |
| Primary completion | 1 March 2024 |
| Estimated completion | 1 December 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- Analysis of body composition
Conditions studied
- Brief Description of Focus of Study — all drugs for Brief Description of Focus of Study →
Sponsor
Tianjin Medical University Cancer Institute and Hospital
Who can join
Adults 18 to 75, any sex, with Brief Description of Focus of Study. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04936750 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tianjin Medical University Cancer Institute and Hospital
- Last refreshed: 14 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04936750.
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