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Study of Oral Nutritional Supplements During Concurrent Chemoradiotherapy for Local Advanced Non-small Cell Lung Cancer

Primary Purpose

Local Advanced Non-small Cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
ONS from the start of radiotherapy
ONS from the time of grade 2 radiation esophagitis
Energy goal-based ONS
Prealbumin goal-based ONS
Thoracic radiotherapy
Weekly DP chemotherapy concurrent with thoracic radiotherapy
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Local Advanced Non-small Cell Lung Cancer focused on measuring Local Advanced Non-small Cell Lung Cancer, Chemoradiotherapy, Oral Nutritional Supplements

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed non-small cell lung cancer.
  • Recieved definitive concurrent chemoradiotherapy.
  • Pretreatment PG-SGA score A to 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.

Sites / Locations

  • Sun yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

A

B

C

D

Arm Description

ONS from the start of radiotherapy; Energy goal-based ONS: daily total nutritional intake of 30-35kcal/kg. Definitive thoracic radiotherapy with total radiation doses of 60-70 Gy; Weekly DP chemotherapy concurrent with thoracic radiotherapy.

ONS from the time of grade 2 radiation esophagitis; Energy goal-based ONS: daily total nutritional intake of 30-35kcal/kg. Definitive thoracic radiotherapy with total radiation doses of 60-70 Gy; Weekly DP chemotherapy concurrent with thoracic radiotherapy.

ONS from the start of radiotherapy; Prealbumin goal-based ONS. Definitive thoracic radiotherapy with total radiation doses of 60-70 Gy; Weekly DP chemotherapy concurrent with thoracic radiotherapy.

ONS from the time of grade 2 radiation esophagitis; Prealbumin goal-based ONS. Definitive thoracic radiotherapy with total radiation doses of 60-70 Gy; Weekly DP chemotherapy concurrent with thoracic radiotherapy.

Outcomes

Primary Outcome Measures

Weight loss

Secondary Outcome Measures

Hemoglobin change
albumin change
Scored Patient-Generated Subjective Global Assessment
rate of grade 3-4 radiation esophagitis
rate of grade 3-4 radiation pneumonitis
Overall Survival

Full Information

First Posted
September 5, 2018
Last Updated
September 14, 2018
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03673657
Brief Title
Study of Oral Nutritional Supplements During Concurrent Chemoradiotherapy for Local Advanced Non-small Cell Lung Cancer
Official Title
A Prospective, Randomized, Phase II Study of Oral Nutritional Supplements During Concurrent Chemoradiotherapy for Local Advanced Non-small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 10, 2018 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This Phase II randomized study is to determine the efficacy of oral nutritional supplements(ONS) during concurrent chemoradiotherapy for local advanced non-small cell lung cancer, and discuss when to deliver ONS and which indicator should be the goal of ONS.
Detailed Description
This Phase II randomized study is to determine the efficacy of oral nutritional supplements(ONS) during concurrent chemoradiotherapy for local advanced non-small cell lung cancer, and discuss when to deliver ONS and which indicator should be the goal of ONS. Patients were randomly assigned to arm A, B, C, D. In arm A, ONS is given from start of CCRT, based on the daily total nutritional intake of 30-35kcal/kg. Patients in arm B are given ONS when they have grade 2 radiation esophagitis, based on the daily total nutritional intake of 30-35kcal/kg. For arm C, ONS is given from start of CCRT, with the goal to keep prealbumin normal. Patients in arm D are given ONS when they have grade 2 radiation esophagitis, with the goal to keep prealbumin normal. All patients received definitive thoracic radiotherapy with total radiation doses of 60-70 Gy, concurrent with weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Local Advanced Non-small Cell Lung Cancer
Keywords
Local Advanced Non-small Cell Lung Cancer, Chemoradiotherapy, Oral Nutritional Supplements

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
ONS from the start of radiotherapy; Energy goal-based ONS: daily total nutritional intake of 30-35kcal/kg. Definitive thoracic radiotherapy with total radiation doses of 60-70 Gy; Weekly DP chemotherapy concurrent with thoracic radiotherapy.
Arm Title
B
Arm Type
Experimental
Arm Description
ONS from the time of grade 2 radiation esophagitis; Energy goal-based ONS: daily total nutritional intake of 30-35kcal/kg. Definitive thoracic radiotherapy with total radiation doses of 60-70 Gy; Weekly DP chemotherapy concurrent with thoracic radiotherapy.
Arm Title
C
Arm Type
Experimental
Arm Description
ONS from the start of radiotherapy; Prealbumin goal-based ONS. Definitive thoracic radiotherapy with total radiation doses of 60-70 Gy; Weekly DP chemotherapy concurrent with thoracic radiotherapy.
Arm Title
D
Arm Type
Experimental
Arm Description
ONS from the time of grade 2 radiation esophagitis; Prealbumin goal-based ONS. Definitive thoracic radiotherapy with total radiation doses of 60-70 Gy; Weekly DP chemotherapy concurrent with thoracic radiotherapy.
Intervention Type
Dietary Supplement
Intervention Name(s)
ONS from the start of radiotherapy
Intervention Description
ONS from the start of radiotherapy
Intervention Type
Dietary Supplement
Intervention Name(s)
ONS from the time of grade 2 radiation esophagitis
Intervention Description
ONS from the time of grade 2 radiation esophagitis
Intervention Type
Dietary Supplement
Intervention Name(s)
Energy goal-based ONS
Intervention Description
Energy goal-based ONS
Intervention Type
Dietary Supplement
Intervention Name(s)
Prealbumin goal-based ONS
Intervention Description
Prealbumin goal-based ONS
Intervention Type
Radiation
Intervention Name(s)
Thoracic radiotherapy
Intervention Description
Definitive thoracic radiotherapy with total radiation doses of 60-70 Gy
Intervention Type
Drug
Intervention Name(s)
Weekly DP chemotherapy concurrent with thoracic radiotherapy
Intervention Description
Weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡) concurrent with thoracic radiotherapy
Primary Outcome Measure Information:
Title
Weight loss
Time Frame
up to 2 months after radiotherapy
Secondary Outcome Measure Information:
Title
Hemoglobin change
Time Frame
up to 2 months after radiotherapy
Title
albumin change
Time Frame
up to 2 months after radiotherapy
Title
Scored Patient-Generated Subjective Global Assessment
Time Frame
up to 2 months after radiotherapy
Title
rate of grade 3-4 radiation esophagitis
Time Frame
up to 1 year after radiotherapy
Title
rate of grade 3-4 radiation pneumonitis
Time Frame
up to 1 year after radiotherapy
Title
Overall Survival
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed non-small cell lung cancer. Recieved definitive concurrent chemoradiotherapy. Pretreatment PG-SGA score A to 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bo Qiu, Attending
Phone
+86-020-87343031
Email
qiubo@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Hui Liu, Professor
Phone
+86-020-87343031
Email
liuhui@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Liu, Professor
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bo Qiu, Attending
Phone
+86-020-87343031
Email
qiubo@sysucc.org.cn
First Name & Middle Initial & Last Name & Degree
Hui Liu, Professor

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19199106
Citation
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.
Results Reference
background
PubMed Identifier
24325888
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.
Results Reference
background
PubMed Identifier
16601440
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.
Results Reference
background
PubMed Identifier
23107855
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.
Results Reference
background
PubMed Identifier
22489794
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.
Results Reference
background
PubMed Identifier
29017827
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.
Results Reference
background
PubMed Identifier
15226773
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.
Results Reference
background
PubMed Identifier
15920748
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.
Results Reference
background
PubMed Identifier
15684319
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.
Results Reference
background
PubMed Identifier
24320097
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.
Results Reference
background
PubMed Identifier
26940529
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.
Results Reference
background

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Study of Oral Nutritional Supplements During Concurrent Chemoradiotherapy for Local Advanced Non-small Cell Lung Cancer

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