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NCT Number: NCT03673657

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.

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Key information

Conditions

Local Advanced Non-small Cell Lung Cancer

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

About this study

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/㎡).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

thoracic radiotherapy

Radiation

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

Weekly DP chemotherapy concurrent with thoracic radiotherapy

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. EORTC Quality of Life Questionnaire C30 (QLQ-C30)

    Time frame: up to 6 months after radiotherapy

    Quality of Life

  3. Scored Patient-Generated Subjective Global Assessment

    Time frame: up to 6 months after radiotherapy

    PG-SGA scores and grades

  4. Toxicities

    Time frame: up to 1 year after radiotherapy

    Treatment-related toxicities, including hematologic adverse effects, radiation pneumonitis, and radiation esophagitis.

  5. Survival outcomes

    Time frame: 3 years

    Including overall survival and progression-free survival.

Other outcomes

  1. Exploratory endpoint

    Time frame: From the start to the end of CCRT

    The association between oral nutritional supplements outcome and the gut microbiota.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2023
First posted
Sep 17, 2018
Registry last updated
Dec 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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