Clinical trial · Interventional
Early IntraVenous Administration of Nutritional Support
Early IntraVenous Administration of Nutritional Support (IVANS) in Metastatic Gastric, Cancer Patients at Nutritional Risk Undergoing First-line Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Changes in anticancer treatment protocols which limit recruitment
Summary
Brief summary (as posted)
The present trial will be conducted to verify if early supplemental parenteral nutrition in combination with nutritional counseling improves survival and the feasibility of chemotherapy, in addition to nutritional status, body composition, functional status and quality of life in treatment-naïve patients with metastatic gastric cancer at nutritional risk undergoing first-line chemotherapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Stomach | Malignant Gastric Neoplasm | ALIAS | 0.90 |
| GastroEsophageal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Early supplemental parenteral nutrition plus nutritional counseling | Other | — | UNRESOLVED |
| Nutritional counseling alone | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Nutritional counseling alone
- description
- Nutritional counseling consists of a personalized dietary prescription with regular consultation by a registered dietitian and telephone interviews, as well as of the use of oral nutritional supplements, when necessary.
- interventionNames
- Other: Nutritional counseling alone
- type
- EXPERIMENTAL
- label
- Supplemental parenteral nutrition plus nutritional counseling
- description
- Patients will receive nutritional counseling in combination with systematic early supplemental home parenteral nutrition since diagnosis.
- interventionNames
- Other: Early supplemental parenteral nutrition plus nutritional counseling
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histologically confirmed diagnosis of metastatic gastric and gastroesophageal cancer; * no previous chemotherapy for metastatic disease; * indication for a first-line chemotherapy with a combination of 2 drugs including platinum derivatives (plus Trastuzumab if HER2+) to be used by investigator's choice within the framework of good clinical practice and in agreement with current Italian Association of Medical Oncology guidelines; * measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST); * presence of nutritional risk (Nutritional Risk Screening 2002 score ≥3); * availability of permanent venous access (Port, Groshong, PICC); * Eastern Cooperative Oncology Group (ECOG) performance status ≤2; * availability of a home parenteral nutrition service to continue nutritional plan as scheduled; * signed informed consent. Exclusion Criteria: * age \<18 years * ECOG performance status \>2 * indication to complete artificial nutrition support (totally compromised spontaneous food-intake) * contraindication to parenteral nutrition (abnormal glucose and electrolytes control, hyper-triglyceridemia, impaired hemodynamic control and fluid retention) * availability of jejunostomy for nutritional purposes * ongoing home artificial nutrition * unfeasible home parenteral nutrition for social/familial reasons * absence of caregivers * patients refusal
References
Publications (1)
- DERIVEDCaccialanza R, Cereda E, Klersy C, Brugnatelli S, Borioli V, Ferrari A, Caraccia M, Lobascio F, Pagani A, Delfanti S, Aprile G, Reni M, Rimassa L, Melisi D, Cascinu S, Battistini L, Candiloro F, Pedrazzoli P. Early intravenous administration of nutritional support (IVANS) in metastatic gastric cancer patients at nutritional risk, undergoing first-line chemotherapy: study protocol of a pragmatic, randomized, multicenter, clinical trial. Ther Adv Med Oncol. 2020 Feb 22;12:1758835919890281. doi: 10.1177/1758835919890281. eCollection 2020. PMID 32127922