NutritionT-NICENCT06332664
Collaborative Tele-Nutritional Care for Patient With Stage IV Cancer
A study testing Early Nutrition Intervention in people with Nutrition, run by Xingchen Peng at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nutrition
- What is being tested?
- Early Nutrition Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteChina
- Study dates
- 28 Mar 2024to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Collaborative Tele-Nutritional Care for Patients With Stage IV Cancer Undergoing Chemotherapy: The Randomised Clinical Trial
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.
- Conditions
- Nutrition
- Being tested
- Early Nutrition Intervention
- Keywords
- cancer cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Nutrition InterventionCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| Early Nutrition Intervention | Experimental | For patients meeting the inclusion criteria and randomly assigned to the intervention group, the investigators will assess their nutritional status monthly. During the home-based period between chemotherapy cycles, the investigators will conduct follow-up and provide care using a mobile application (APP). In the event of new nutritional risks emerging in patients, timely recommendations for medical consultation will be made, and nutritional plans will be formulated accordingly. Receives: Combination Product: Early Nutrition Intervention |
| standard care | No intervention | Patients randomly assigned to the standard treatment group will receive standard care for cancer patients and will not be scheduled for interdisciplinary supportive therapy assessment unless requested by the patient, the primary oncologist, or their family. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: every month, up to half year
Secondary outcomes (3)
body weight
Changes in body weight over 6 months
Measured: every month, up to half year
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.
Measured: every month, up to half year
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.
Measured: every month, up to half year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start28 Mar 2024
- Primary completion30 Aug 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xingchen Peng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xingchen Peng, West China Hospital
- Investigators
- XingChen Peng, Ph.D, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332664
- Sponsor's protocol ID
- 2023-2330
- Acronym
- T-NICE
- Status last verified
- Nov 2025
- First submitted
- 10 Mar 2024
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Tele-Nutritional Care for Patients With Stage IV Cancer Undergoing Chemotherapy: The Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT06332664
- Acronym / sponsor ID
- T-NICE / 2023-2330
- Conditions
- Nutrition
- Keywords
- cancer cachexia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Xingchen PengUniversity, hospital or other
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Nutrition Intervention | Experimental | Combination Product: Early Nutrition InterventionFor patients meeting the inclusion criteria and randomly assigned to the intervention group, the investigators will assess their nutritional status monthly. During the home-based period between chemotherapy cycles, the investigators will conduct follow-up and provide care using a mobile application (APP). In the event of new nutritional risks emerging in patients, timely recommendations for medical consultation will be made, and nutritional plans will be formulated accordingly. |
| standard care | No intervention | –Patients randomly assigned to the standard treatment group will receive standard care for cancer patients and will not be scheduled for interdisciplinary supportive therapy assessment unless requested by the patient, the primary oncologist, or their family. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Nutrition InterventionThis 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. | Combination product | Early Nutrition Intervention |
Primary outcome
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)
3 secondary outcomes
body weight
Time frame: every month, up to half year
Nutritional risk and malnutrition status
Time frame: every month, up to half year
Nutritional risk and malnutrition status
Time frame: every month, up to half year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
XingChen Peng, Ph.D principal investigator
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Nutrition Intervention in people with Nutrition, run by Xingchen Peng at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of cachexia (time frame: every month, up to half year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.