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NCT Number: NCT06332664

Collaborative Tele-Nutritional Care for Patient With Stage IV Cancer

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.

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Key information

Conditions

Nutrition

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West China Hospital, Sichuan Universit

Chengdu, Sichuan, 610041, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patients should be at the range of 18-80 years old, Eastern Cooperative Oncology Group (ECOG) 0-1.
  • 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

Treatment and study plan

Early Nutrition Intervention

Combination Product

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.

Primary outcomes

  1. 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

  1. body weight

    Time frame: every month, up to half year

    Changes in body weight over 6 months

  2. Nutritional risk and malnutrition status

    Time frame: 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.

  3. Nutritional risk and malnutrition status

    Time frame: every month, up to half year

    Patient-Generated Subjective Global Assessment (PG-SGA)，the minimum value is 0 and maximum value is 20, and higher scores mean a worse outcome.

Sponsors and collaborators

Lead sponsor

Xingchen Peng

Other

Registry information

Official study title

Collaborative Tele-Nutritional Care for Patients With Stage IV Cancer Undergoing Chemotherapy: The Randomised Clinical Trial

Acronym: T-NICE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 27, 2024
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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