A Prospective, Single-arm, Phase II Study of Early Nutritional Intervention During Concurrent Chemoradiotherapy for Local Advanced Non-small Cell Lung Cancer
Sponsor study identifier
interventional
67
1 country
1
Study Start
August 10, 2018
Actual (reported)Primary Completion
March 16, 2020
Actual (reported)Study Completion
August 31, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 10, 2018
Actual (reported)September 5, 2018
Actual (reported)September 17, 2018
Actual (reported)March 16, 2020
Actual (reported)August 31, 2023
Actual (reported)The incidence of weight loss ≥5% during the treatment
The proportion of patients experiencing a weight loss of 5% or more during the CCRT
From the start to the end of CCRT
Nutrition-related parameters
up to 6 months after radiotherapy
EORTC Quality of Life Questionnaire C30 (QLQ-C30)
up to 6 months after radiotherapy
Scored Patient-Generated Subjective Global Assessment
up to 6 months after radiotherapy
Toxicities
up to 1 year after radiotherapy
Survival outcomes
3 years
Exploratory endpoint
From the start to the end of CCRT
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.
Nutrition counseling and oral nutritional supplements from the start of radiotherapy; weekly counseling sessions; daily energy intake of approximately 30 kcal/kg.
Definitive thoracic radiotherapy with total radiation doses of 60-68 Gy
Sun yat-sen University Cancer Center
Guangzhou, Guangdong, 510000, China
Bovio 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.
Kiss 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.
Hui Liu, Professor
Sun Yat-sen University
67 participants (actual enrollment reported by the registry).
First Submitted
September 5, 2018
First Posted
September 17, 2018
Study Start
August 10, 2018
Actual (reported)Weekly docetaxel (25mg/㎡) and nedaplatin (25mg/㎡) concurrent with thoracic radiotherapy
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Unsal 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.
Luo 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.
Sanchez-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.
Ma 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.
Isenring EA, Capra S, Bauer JD. Nutrition intervention is beneficial in oncology outpatients receiving radiotherapy to the gastrointestinal or head and neck area. Br J Cancer. 2004 Aug 2;91(3):447-52. doi: 10.1038/sj.bjc.6601962.
Ravasco P, Monteiro-Grillo I, Marques Vidal P, Camilo ME. Impact of nutrition on outcome: a prospective randomized controlled trial in patients with head and neck cancer undergoing radiotherapy. Head Neck. 2005 Aug;27(8):659-68. doi: 10.1002/hed.20221.
Ravasco P, Monteiro-Grillo I, Vidal PM, Camilo ME. Dietary counseling improves patient outcomes: a prospective, randomized, controlled trial in colorectal cancer patients undergoing radiotherapy. J Clin Oncol. 2005 Mar 1;23(7):1431-8. doi: 10.1200/JCO.2005.02.054. Epub 2005 Jan 31.
Kiss NK, Krishnasamy M, Isenring EA. The effect of nutrition intervention in lung cancer patients undergoing chemotherapy and/or radiotherapy: a systematic review. Nutr Cancer. 2014;66(1):47-56. doi: 10.1080/01635581.2014.847966. Epub 2013 Dec 9.
Sanders KJ, Hendriks LE, Troost EG, Bootsma GP, Houben RM, Schols AM, Dingemans AM. Early Weight Loss during Chemoradiotherapy Has a Detrimental Impact on Outcome in NSCLC. J Thorac Oncol. 2016 Jun;11(6):873-9. doi: 10.1016/j.jtho.2016.02.013. Epub 2016 Mar 3.
Primary Completion
March 16, 2020
Actual (reported)Study Completion
August 31, 2023
Actual (reported)Last Updated
December 8, 2023
Record last verified: 2023-12
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