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

Local Advanced Non-small Cell Lung Cancer Clinical Trial

Official title:

A Prospective, Single-arm, Phase II Study of Early Nutritional Intervention During Concurrent Chemoradiotherapy for Local Advanced Non-small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03673657
• Other study ID #: GASTO-1041
• Status: Completed
• Phase: Phase 2
• Start date: August 10, 2018
• Est. completion date: August 31, 2023

Study information

• Verified date: December 2023
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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. 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. Weekly counseling sessions, conducted by both doctors and nurses, aimed to educate patients on regulating their regular dietary intake to meet specific energy, protein, and other macronutrient requirements. Dietary advice provided precise instructions on food type and quantity, meal frequency, and calorie or protein intake to ensure a daily energy intake of approximately 30 kcal/kg. All patients received definitive thoracic radiotherapy with total radiation doses of 60-68 Gy, concurrent with weekly docetaxel (25mg/㎡) and nedaplatin (25mg/㎡).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: August 31, 2023
• Est. primary completion date: March 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Local Advanced Non-small Cell Lung Cancer
• Lung Neoplasms

Intervention

Dietary Supplement:
• Early Nutrition Intervention from the start of CCRT
Nutrition counseling and oral nutritional supplements from the start of radiotherapy; weekly counseling sessions; daily energy intake of approximately 30 kcal/kg.

Radiation:
• Thoracic radiotherapy
Definitive thoracic radiotherapy with total radiation doses of 60-68 Gy

Drug:
• Weekly DP chemotherapy concurrent with thoracic radiotherapy
Weekly docetaxel (25mg/?) and nedaplatin (25mg/?) concurrent with thoracic radiotherapy

Locations

Country	Name	City	State
China	Sun yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory endpoint	The association between oral nutritional supplements outcome and the gut microbiota.	From the start to the end of CCRT
Primary	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	Nutrition-related parameters	Nutrition-related parameters, including weight, body mass index (BMI), hemoglobin (HGB), serum albumin (ALB), pre-albumin (PA), lymphocyte (LY)	up to 6 months after radiotherapy
Secondary	EORTC Quality of Life Questionnaire C30 (QLQ-C30)	Quality of Life	up to 6 months after radiotherapy
Secondary	Scored Patient-Generated Subjective Global Assessment	PG-SGA scores and grades	up to 6 months after radiotherapy
Secondary	Toxicities	Treatment-related toxicities, including hematologic adverse effects, radiation pneumonitis, and radiation esophagitis.	up to 1 year after radiotherapy
Secondary	Survival outcomes	Including overall survival and progression-free survival.	3 years