Clinical trial NCT06332664: Early Nutrition Intervention for Stage IV Cancer Patients
Official title: Early Nutrition Intervention for Stage IV Cancer Patients：a Single-center,Open,Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nutrition
Cancer Metastatic
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In China, the treatment of advanced-stage cancer often follows a pattern where the management of patients is primarily overseen by oncologists who focus on addressing the main clinical symptoms and intervening accordingly.

However, symptoms such as appetite loss, weight loss, and anxiety are often overlooked. It is common for clinical nutritionists to passively enter oncology wards to conduct comprehensive nutritional assessments and develop nutrition plans only when patients exhibit significant malnutrition, upon request from oncologists or patients and their families.

Against this background, the investigators integrated clinical nutritionists into the oncology treatment team and established a proactive nutritional intervention team specifically targeting stage IV cancer patients. This initiative aims to conduct a single-center, open-label, randomized parallel-group prospective study, with the following objectives: 1) to evaluate the impact of this model on the nutritional status, survival, and quality of life of advanced-stage cancer patients, and 2) to further optimize this model for widespread replication in clinical practice.


Eligibility criteria: Inclusion Criteria:

1. The patients should be at the range of 18-80 years old, Eastern Cooperative Oncology Group (ECOG) 0-1.
2. The patients should be diagnosed, untreated M1 advanced cancer patients requiring chemotherapy;
3. The patients should have good cognitive and reading abilities to complete questionnaires;
4. The patients should have ≥3 months expected survival period

Exclusion Criteria:

1. Patients with neurological or psychiatric disorders affecting cognitive function, including central nervous system metastases from tumors;
2. Patients with severe diseases affecting digestion, metabolism, or food intake;
3. Presence of contraindications to chemotherapy;
4. Patients in a cachectic state or refractory cachexia;
5. Patients with PG-SGA score ≥9 points

Primary outcomes:
measure: the incidence of cachexia
timeFrame: every month, up to half year
Secondary outcomes:
measure: overall survival ；progression-free survival
timeFrame: every month, up to half year
measure: Physical Fitness Status
timeFrame: every month, up to half year
measure: BMI
timeFrame: every month, up to half year
measure: Nutritional risk and malnutrition status
timeFrame: every month, up to half year
measure: Patient's emotional changes
timeFrame: every month, up to half year
measure: Caregiver psychological burden
timeFrame: every month, up to half year
measure: Patient's physical, social, and cognitive functioning
timeFrame: every month, up to half year
measure: incidence of Sarcopenia
timeFrame: every month, up to half year
measure: Nutritional risk and malnutrition status
timeFrame: every month, up to half year
measure: Patient's emotional changes
timeFrame: every month, up to half year
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital, Sichuan Universit
state: Sichuan
Study officials:
affiliation: West China Hospital
name: XingChen Peng, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: