Study of Early Nutritional Intervention During Concurrent Chemoradiotherapy for Local Advanced Non-small Cell Lung Cancer

NCT03673657 | Completed Phase 2

• 1 other identifier: GASTO-1041
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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

Local Advanced Non-small Cell Lung Cancer

Keywords

Local Advanced Non-small Cell Lung Cancer; Chemoradiotherapy; Early nutritional intervention

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

Other Outcomes (1)

• Exploratory endpoint

  From the start to the end of CCRT

Study Arms (1)

The study group

EXPERIMENTAL

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.

Dietary Supplement: Early Nutrition Intervention from the start of CCRT; Radiation: Thoracic radiotherapy; Drug: Weekly DP chemotherapy concurrent with thoracic radiotherapy

Interventions

Early Nutrition Intervention from the start of CCRT DIETARY_SUPPLEMENT

Nutrition counseling and oral nutritional supplements from the start of radiotherapy; weekly counseling sessions; daily energy intake of approximately 30 kcal/kg.

The study group

Thoracic radiotherapy RADIATION

Definitive thoracic radiotherapy with total radiation doses of 60-68 Gy

The study group

Weekly DP chemotherapy concurrent with thoracic radiotherapy DRUG

Weekly docetaxel (25mg/㎡) and nedaplatin (25mg/㎡) concurrent with thoracic radiotherapy

The study group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Severe impairment of intestinal function, or intolerance of enteral nutrition.
• Severe vomiting, gastrointestinal bleeding, or intestinal obstruction.
• Severe malnutrition, or intolerance of chemoradiotherapy.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

Location

Related Publications (11)

• 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.

  PMID: 19199106 BACKGROUND

• 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.

  PMID: 24325888 BACKGROUND

• 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.

  PMID: 16601440 BACKGROUND

• 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.

  PMID: 23107855 BACKGROUND

• 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.

  PMID: 22489794 BACKGROUND

• 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.

  PMID: 29017827 BACKGROUND

• 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.

  PMID: 15226773 BACKGROUND

• 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.

  PMID: 15920748 BACKGROUND

• 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.

  PMID: 15684319 BACKGROUND

• 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.

  PMID: 24320097 BACKGROUND

• 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.

  PMID: 26940529 BACKGROUND

Study Officials

• Hui Liu, Professor

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 17, 2018
• Study Start: August 10, 2018
• Primary Completion: March 16, 2020
• Study Completion: August 31, 2023
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)