Clinical trial · Interventional
Study of Early Nutritional Intervention During Concurrent Chemoradiotherapy for Local Advanced Non-small Cell Lung Cancer
A Prospective, Single-arm, Phase II Study of Early Nutritional Intervention During Concurrent Chemoradiotherapy for Local Advanced Non-small Cell Lung Cancer
NCT03673657CI-TRIAL-00072084completedPhase 2ClinicalTrials.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)
This single-arm phase II prospective study is to determine the efficacy of early nutritional intervention during concurrent chemoradiotherapy for local advanced non-small cell lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Local Advanced Non-small Cell Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Early Nutrition Intervention from the start of CCRT | Dietary Supplement | — | UNRESOLVED |
| Thoracic radiotherapy | Radiation | — | UNRESOLVED |
| Weekly DP chemotherapy concurrent with thoracic radiotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- The study group
- description
- Patients in the study group received early nutritional intervention, including individualized nutrition counseling and oral nutritional supplements from the initiation of CCRT to 2 weeks after its completion. Energy goal: daily total nutritional intake of about 30 kcal/kg. Definitive thoracic radiotherapy with total radiation doses of 60-68 Gy; Weekly DP chemotherapy concurrent with thoracic radiotherapy.
- interventionNames
- Dietary Supplement: Early Nutrition Intervention from the start of CCRT
- Radiation: Thoracic radiotherapy
- Drug: Weekly DP chemotherapy concurrent with thoracic radiotherapy
Primary outcomes (1)
- measure
- The incidence of weight loss ≥5% during the treatment
- timeFrame
- From the start to the end of CCRT
- description
- The proportion of patients experiencing a weight loss of 5% or more during the CCRT
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed unresectable stage IIIA-IIIC non-small cell lung cancer. * Recieved definitive concurrent chemoradiotherapy. * Pretreatment PG-SGA score A or B. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Estimated life expectancy of at least 6 months. * Without contraindication for chemoradiotherapy. Exclusion Criteria: * Severe impairment of intestinal function, or intolerance of enteral nutrition. * Severe vomiting, gastrointestinal bleeding, or intestinal obstruction. * Severe malnutrition, or intolerance of chemoradiotherapy.
References
Publications (11)
- BACKGROUNDBovio G, Montagna G, Bariani C, Baiardi P. Upper gastrointestinal symptoms in patients with advanced cancer: relationship to nutritional and performance status. Support Care Cancer. 2009 Oct;17(10):1317-24. doi: 10.1007/s00520-009-0590-x. Epub 2009 Feb 8. PMID 19199106
- BACKGROUNDKiss N, Isenring E, Gough K, Krishnasamy M. The prevalence of weight loss during (chemo)radiotherapy treatment for lung cancer and associated patient- and treatment-related factors. Clin Nutr. 2014 Dec;33(6):1074-80. doi: 10.1016/j.clnu.2013.11.013. Epub 2013 Nov 25. PMID 24325888
- BACKGROUNDUnsal 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
- BACKGROUNDLuo J, Chen YJ, Narsavage GL, Ducatman A. Predictors of survival in patients with non-small cell lung cancer. Oncol Nurs Forum. 2012 Nov;39(6):609-16. doi: 10.1188/12.ONF.609-616. PMID 23107855
- BACKGROUNDSanchez-Lara K, Turcott JG, Juarez E, Guevara P, Nunez-Valencia C, Onate-Ocana LF, Flores D, Arrieta O. Association of nutrition parameters including bioelectrical impedance and systemic inflammatory response with quality of life and prognosis in patients with advanced non-small-cell lung cancer: a prospective study. Nutr Cancer. 2012;64(4):526-34. doi: 10.1080/01635581.2012.668744. Epub 2012 Apr 10. PMID 22489794
- BACKGROUNDMa L, Ye W, Li Q, Wang B, Luo G, Chen Z, Guo S, Qiu B, Liu H. Subjective Global Assessment (SGA) Score Could Be a Predictive Factor for Radiation Pneumonitis in Lung Cancer Patients With Normal Pulmonary Function Treated by Intensity-Modulated Radiation Therapy and Concurrent Chemotherapy. Clin Lung Cancer. 2018 Mar;19(2):e211-e217. doi: 10.1016/j.cllc.2017.09.001. Epub 2017 Sep 19. PMID 29017827