Clinical trial NCT03673657: Study of Early Nutritional Intervention During Concurrent Chemoradiotherapy for Local Advanced Non-small Cell Lung Cancer
Official title: A Prospective, Single-arm, Phase II Study of Early Nutritional Intervention During Concurrent Chemoradiotherapy for Local Advanced Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Local Advanced Non-small Cell Lung Cancer
Keywords: Local Advanced Non-small Cell Lung Cancer
Chemoradiotherapy
Early nutritional intervention
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-09-17
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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/㎡).

Eligibility criteria: 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.

Primary outcomes:
measure: The incidence of weight loss ≥5% during the treatment
timeFrame: From the start to the end of CCRT
Secondary outcomes:
measure: Nutrition-related parameters
timeFrame: up to 6 months after radiotherapy
measure: EORTC Quality of Life Questionnaire C30 (QLQ-C30)
timeFrame: up to 6 months after radiotherapy
measure: Scored Patient-Generated Subjective Global Assessment
timeFrame: up to 6 months after radiotherapy
measure: Toxicities
timeFrame: up to 1 year after radiotherapy
measure: Survival outcomes
timeFrame: 3 years
Other outcomes:
measure: Exploratory endpoint
timeFrame: From the start to the end of CCRT
Locations:
city: Guangzhou
country: China
facility: Sun yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Hui Liu, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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