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

December 2, 2023 updated by: Hui Liu, Sun Yat-sen University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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/㎡).

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Sun Yat-sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The study group

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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of weight loss ≥5% during the treatment
Time Frame: From the start to the end of CCRT
The proportion of patients experiencing a weight loss of 5% or more during the CCRT
From the start to the end of CCRT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutrition-related parameters
Time Frame: up to 6 months after radiotherapy
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
EORTC Quality of Life Questionnaire C30 (QLQ-C30)
Time Frame: up to 6 months after radiotherapy
Quality of Life
up to 6 months after radiotherapy
Scored Patient-Generated Subjective Global Assessment
Time Frame: up to 6 months after radiotherapy
PG-SGA scores and grades
up to 6 months after radiotherapy
Toxicities
Time Frame: up to 1 year after radiotherapy
Treatment-related toxicities, including hematologic adverse effects, radiation pneumonitis, and radiation esophagitis.
up to 1 year after radiotherapy
Survival outcomes
Time Frame: 3 years
Including overall survival and progression-free survival.
3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory endpoint
Time Frame: From the start to the end of CCRT
The association between oral nutritional supplements outcome and the gut microbiota.
From the start to the end of CCRT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Hui Liu, Professor, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2018

Primary Completion (Actual)

March 16, 2020

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

September 5, 2018

First Submitted That Met QC Criteria

September 14, 2018

First Posted (Actual)

September 17, 2018

Study Record Updates

Last Update Posted (Actual)

December 8, 2023

Last Update Submitted That Met QC Criteria

December 2, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GASTO-1041

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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