Collaborative Tele-Nutritional Care for Patients With Stage IV Cancer Undergoing Chemotherapy: The Randomised Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 158
- Locations
- 1
- Primary Endpoint
- the incidence of cachexia
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The patients should be at the range of 18-80 years old, Eastern Cooperative Oncology Group (ECOG) 0-
- •The patients should be diagnosed, untreated stage IV cancer patients requiring chemotherapy;
- •The patients should have good cognitive and reading abilities to complete questionnaires;
- •The patients should have ≥3 months expected survival period
Exclusion Criteria
- •Patients with neurological or psychiatric disorders affecting cognitive function, including central nervous system metastases from tumors;
- •Patients with severe diseases affecting digestion, metabolism, or food intake;
- •Presence of contraindications to chemotherapy;
- •Patients in a cachectic state or refractory cachexia;
- •Patients with PG-SGA score ≥9 points
Outcomes
Primary Outcomes
the incidence of cachexia
Time Frame: 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 Outcomes
- Nutritional risk and malnutrition status(every month, up to half year)
- body weight(every month, up to half year)
- Nutritional risk and malnutrition status(every month, up to half year)
Investigators
Xingchen Peng
PhD, Professor
West China Hospital