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NCT03061370
Sarcopenia and Visceral Obesity in Esophageal and Gastric Cancer
trial testing Esophagectomy or Gastrectomy in Esophageal Cancer in 317 participants. Completed in 1 January 2019.
1 January 2017
Quick facts
| Lead sponsor | St. James's Hospital, Ireland |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 317 |
| Start date | 1 January 2010 |
| Primary completion | 1 January 2017 |
| Estimated completion | 1 January 2019 |
| Sites | 2 locations across Ireland |
Drugs / interventions tested
- Esophagectomy or Gastrectomy
Conditions studied
- Esophageal Cancer — all drugs for Esophageal Cancer →
- Gastric Cancer — all drugs for Gastric Cancer →
- Sarcopenia — all drugs for Sarcopenia →
- Sarcopenic Obesity — all drugs for Sarcopenic Obesity →
Sponsor
St. James's Hospital, Ireland
Who can join
18 and older, any sex, with Esophageal Cancer or Gastric Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In line with improvements in oncologic outcome for patients with esophageal cancer, the attritional impact of curative treatment with respect to functional status and health-related quality of life (HR-QL) in survivorship is increasingly an important focus. Functional recovery after surgery for esophageal cancer is commonly confounded by anorexia and early satiety, which may reduce oral nutrient intake with consequent malnutrition and weight loss. One in three disease-free patients has more than fifteen percent body weight loss at three years after esophagectomy. The ESPEN Special Interest Group on cachexia-anorexia in chronic wasting diseases has defined sarcopenia as skeletal muscle index (SMI) of ≤39 cm2/m2 for women and ≤55cm2/m2 for men, while similar cut-off points have been validated in upper gastrointestinal and respiratory malignancies (less than 38.5 cm2/m2 for women and 52.4 cm2/m2 for men). The European Working Group on Sarcopenia in Older People (EWGSOP) additionally recommends that assessment should also include determination of muscle function, for example gait speed or grip strength, where possible. The presence of sarcopenia is associated with increase treatment-associated morbidity, impaired HR-QL, reduced physical and role functioning, and increased pain scores in older adults. In addition, a previous longitudinal study demonstrated that the decline in HR-QL over a six year period in older adults was accelerated in the presence of sarcopenia. As such, sarcopenia may represent a modifiable barrier to recovery and subsequent retention of HR-QL and functional status, and may reinforce a persistent illness identity, among patients following potentially curative treatment for esophageal cancer.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03061370
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other St. James's Hospital, Ireland trials
Trials by the same sponsor.
- NCT06550063 — HER2 Status in Esophagogastric Adenocarcinoma and Its Associations With Patient's Clinicopathological Outcomes · recruiting
- NCT05169645 — STOP CSUA: phySical acTivity, mOod and sleeP in Chronic Spontaneous Urticaria and Angioedema · unknown
- NCT04974931 — Application of PREVENA in Reducing Surgical Site Complications Following Reversal of Ileostomy or Colostomy · NA · unknown
- NCT03871023 — Prophylactic Negative Wound Therapy in Laparotomy Wounds. · NA · unknown
- NCT04152044 — Obesity and Liver Function in Oesophageal Cancer · unknown
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 NCT03061370 (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 St. James's Hospital, Ireland
- Last refreshed: 26 March 2020
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/NCT03061370.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing