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Trial Title:
Early Nutrition Intervention for M1 Stage Cancer Patients
NCT ID:
NCT06332664
Condition:
Nutrition
Cancer Metastatic
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Participant)
Intervention:
Intervention type:
Combination Product
Intervention name:
Early Nutrition Intervention
Description:
This involves a multidisciplinary team intervention, including oncologists,
nutritionists, and nurses. Additionally, the intervention introduces a team-developed
mobile application (APP) for the purpose of regular patient follow-ups to identify
nutritional risks promptly and facilitate timely interventions. Patients identified as at
risk through the app follow-up will be referred to the nutrition clinic for consultation
to address nutritional concerns. For advanced-stage cancer patients undergoing monthly
chemotherapy hospitalizations, comprehensive assessments encompassing nutrition,
psychological aspects, and other facets will be conducted during hospital stays. When
deemed necessary, patients will receive dietary guidance and nutritional support.
Arm group label:
Early Nutrition Intervention
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 M1 advanced-stage 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.
Criteria for 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 requiring primary tumor radiation therapy.
6. Patients with PG-SGA score ≥9 points
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
West China Hospital, Sichuan Universit
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Recruiting
Contact:
Last name:
XingChen Peng, Ph.D
Phone:
+8618980606753
Email:
pxx2014@163.com
Start date:
January 1, 2024
Completion date:
July 1, 2025
Lead sponsor:
Agency:
Xingchen Peng
Agency class:
Other
Source:
West China Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06332664
