Early Nutrition Intervention for M1 Stage Cancer Patients

Nutrition Clinical Trial

Official title:

Early Nutrition Intervention for M1 Stage Cancer Patients：a Single-center,Open,Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06332664
• Other study ID #: 2023-2330
• Status: Recruiting
• Phase: Early Phase 1
• Start date: January 1, 2024
• Est. completion date: July 1, 2025

Study information

• Verified date: March 2024
• Source: West China Hospital
• Contact: XingChen Peng, Ph.D
• Phone: +8618980606753
• Email: pxx2014[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 194
• Est. completion date: July 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer Metastatic
• Nutrition

Intervention

Combination Product:
• Early 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.

Locations

Country	Name	City	State
China	West China Hospital, Sichuan Universit	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Xingchen Peng

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of cachexia	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)	every month, up to half year
Secondary	overall survival ;progression-free survival	Progression-free survival (PFS) was assessed from the first day of treatment with ICIs to the earliest signs of disease progression or death from any cause. Patients who were alive but without progression were censored at the time of last follow-up.; OS was calculated from the date of starting ICI to the date of death due to all-cause. Patients who are alive at the date of data cutoff were censored at the time of last follow-up.	every month, up to half year
Secondary	Physical Fitness Status	Karnofsky Performance Score,the minimum value is 0 and maximum value is 100, and higher scores mean a better outcome.	every month, up to half year
Secondary	BMI	Changes in body weight and Body Mass Index (BMI)	every month, up to half year
Secondary	Nutritional risk and malnutrition status	Nutrition Risk Screening 2002 (NRS2002) ,the minimum value is 0 and maximum value is 7, and higher scores mean a worse outcome.	every month, up to half year
Secondary	Patient's emotional changes	Evaluation through Hospital Anxiety and Depression Scale (HADS),the minimum value is 0 and maximum value is 42, and higher scores mean a worse outcome.	every month, up to half year
Secondary	Caregiver psychological burden	Assessment via Caregiver Burden Scale,the minimum value is 0 and maximum value is 7, and higher scores mean a worse outcome.	every month, up to half year
Secondary	Patient's physical, social, and cognitive functioning	Assessed using Patient Health Questionnaire-9 (PHQ-9),the minimum value is 0 and maximum value is 27, and higher scores mean a worse outcome.	every month, up to half year
Secondary	incidence of Sarcopenia	while muscle function alterations are assessed via the Short Physical Performance Battery (SPPB), including sit-to-stand tests, the 400-meter walk test, and grip strength measurements.	every month, up to half year
Secondary	Nutritional risk and malnutrition status	Patient-Generated Subjective Global Assessment (PG-SGA),the minimum value is 0 and maximum value is 20, and higher scores mean a worse outcome.	every month, up to half year
Secondary	Patient's emotional changes	Distress Thermometer (DT),the minimum value is 0 and maximum value is 10 and higher scores mean a worse outcome.	every month, up to half year