Clinical trial · Interventional
Nutritional Psychological Intervention and Vomit-free Management on Survival and Quality of Life in Advanced Gastrointestinal Tumors
NCT06223230CI-TRIAL-00073419unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Aims to observe and evaluate the impact of survival and quality of life of patients with gastrointestinal tumors such as advanced esophageal, gastric, liver, pancreatic, and colorectal cancers through nutritional-psychological interventions versus no-vomit management compared to standard antitumor therapy alone
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 |
|---|---|---|---|
| Digestive System Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
| Digestive System Neoplasm | Digestive System Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nutritional psychological interventions and vomit-free management | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Study group
- description
- First-line treatment received standard antitumor therapy and nutritional psychological interventions with and without vomit management
- interventionNames
- Other: Nutritional psychological interventions and vomit-free management
- type
- NO_INTERVENTION
- label
- Control group
- description
- First-line treatment receives standard antitumor therapy
Primary outcomes (1)
- measure
- Median progression-free survival time
- timeFrame
- Approximately 40 months from date of the first participant randomization
- description
- Progression-free survival is defined as the period from the date of treatment to the date of the first occurrence of disease progression or death from any cause, whichever occurs first. Median progression-free survival is the time to progression-free survival that corresponds to when the cumulative progression-free survival rate is 0.5, indicating that 50% of individuals will live through this time without disease progression.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18-75, male or female; 2. Patients with advanced esophageal cancer, gastric cancer, liver cancer and colorectal cancer and other gastrointestinal tumors diagnosed by pathological histology or cytology; 3. Expected survival ³ 8 weeks and able to receive long-term follow-up; 4. Eastern Cooperative Oncology Group(ECOG)-Performance Status(PS) score of 0-2; 5. First-line treatment receiving standard oncology treatment and nutritional psychological intervention and vomit-free management group (study group); first-line treatment receiving only standard oncology treatment group (control group); 6. Voluntarily signing an informed consent form. Exclusion Criteria: 1. Other malignant tumors diagnosed within the previous 5 years, except for effectively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or effectively resected in situ cervical cancer or breast cancer; 2. history of psychiatric illness prior to the diagnosis of the tumor 3. patients who resist treatment 4. patients with poorly controlled severe heart disease, liver or kidney insufficiency, severe anemia, multiple lymph node enlargement, leukopenia, etc; 5. patients who are pregnant or have a pregnancy plan; 6. patients who, in the judgment of the investigator, are not suitable for inclusion in this study.
References
Publications (11)
- RESULTBray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. PMID 30207593
- RESULTChen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25. PMID 26808342
- RESULTMcCreery E, Costello J. Providing nutritional support for patients with cancer cachexia. Int J Palliat Nurs. 2013 Jan;19(1):32-7. doi: 10.12968/ijpn.2013.19.1.32. PMID 23354431
- RESULTCaillet P, Liuu E, Raynaud Simon A, Bonnefoy M, Guerin O, Berrut G, Lesourd B, Jeandel C, Ferry M, Rolland Y, Paillaud E. Association between cachexia, chemotherapy and outcomes in older cancer patients: A systematic review. Clin Nutr. 2017 Dec;36(6):1473-1482. doi: 10.1016/j.clnu.2016.12.003. Epub 2016 Dec 18. PMID 28017447
- RESULTUnsal D, Mentes B, Akmansu M, Uner A, Oguz M, Pak Y. Evaluation of nutritional status in cancer patients receiving radiotherapy: a prospective study. Am J Clin Oncol. 2006 Apr;29(2):183-8. doi: 10.1097/01.coc.0000198745.94757.ee. PMID 16601440
- RESULTHill A, Kiss N, Hodgson B, Crowe TC, Walsh AD. Associations between nutritional status, weight loss, radiotherapy treatment toxicity and treatment outcomes in gastrointestinal cancer patients. Clin Nutr. 2011 Feb;30(1):92-8. doi: 10.1016/j.clnu.2010.07.015. Epub 2010 Aug 17. PMID 20719409
- RESULTBourdeanu L, Frankel P, Yu W, Hendrix G, Pal S, Badr L, Somlo G, Luu T. Chemotherapy-induced nausea and vomiting in Asian women with breast cancer receiving anthracycline-based adjuvant chemotherapy. J Support Oncol. 2012 Jul-Aug;10(4):149-54. doi: 10.1016/j.suponc.2011.10.007. Epub 2012 Jan 4.