Nutrition
Conditions
Keywords
cancer cachexia
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.
Interventions
COMBINATION_PRODUCTEarly Nutrition Intervention
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.
Sponsors
Xingchen Peng
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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 stage IV 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the incidence of cachexia | every month, up to half year | The definition and classification of cancer cachexia was used by an international consensus \[9, 10\]: (1) weight loss \> 5% over the past 6 months (in the absence of simple starvation), (2) BMI \< 20 and any degree of weight loss \> 2%, or (3) appendicular skeletal muscle index consistent with sarcopenia and any degree of weight loss \> 2%. The assessment of skeletal muscle depletion was used by mid-upper arm muscle area by anthropometry (men \< 32 cm2, women \< 18 cm2) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| body weight | every month, up to half year | Changes in body weight over 6 months |
| Nutritional risk and malnutrition status | every month, up to half year | Nutrition Risk Screening 2002 (NRS2002) ，the minimum value is 0 and maximum value is 7, and higher scores mean a worse outcome. |
Countries
China
Outcome results
None listed