CancerNCT05802381
the Safety and Effectiveness of Protein Supplements on Cancer Patients With Nutritional Risk and Malnutrition
A study testing protein supplement and nutrition counseling in people with Cancer and Malnutrition, run by Peking Union Medical College Hospital.
Trial summary
Nutritional risk and malnutrition is common in cancer patients, which is one of the significant factors affecting the overall survival, toxicity during anticancer treatment, and quality of life among patients with cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Malnutrition
- What is being tested?
- protein supplement and nutrition counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Apr 2023to Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Age>=18years old;
- Initial treatment patients with lung/gastrointestinal/esophageal cancer
- Patients with nutritional risk (NRS-2002≥3) ;
- Patients are able to provide written informed consent.
Who cannot join
- • People who are allergic to whey protein.
- Participants received any drugs or supplements known to influence the outcomes, such as protein powder, anabolic steroids, or glucocorticoids before the 3 months preceding the study.
- Participants with gastrointestinal bleeding or intestinal obstruction, or any contraindication for oral intake
- Concurrent severe cardiac disease, liver and renal failure, which may significantly interfere with study compliance.
- Participants with electronic or mental device.
- Women in pregnancy or lactation period
Trial locations and contacts
No sites are listed yet.
About this study
Nutritional risk and malnutrition is common in cancer patients, which is one of the significant factors affecting the overall survival, toxicity during anticancer treatment, and quality of life among patients with cancer. Previous studies have shown that the increased protein intake can stimulate muscle synthesis, and improve muscle mass, strength, function, overall survival, and quality of life. The current study is going to investigate the effectiveness and safety of protein supplements on patients with cancer, in order to provide a reference for further nutrition treatment.
Read the detailed description
An anticipated total of 100 participants will randomly assigned to receive either a 20-gram protein supplement per day or nutrition counseling to increase the protein intake. there will be a total of 3 study visits, and dietary assessment and blood sample collection will occur at every study visit. Intention-to-treat analysis (ITT) and per-protocol analysis (PP) will be used in statistical analysis.
- Conditions
- Cancer, Malnutrition
- Being tested
- protein supplement, nutrition counseling
- Keywords
- protein, malnutrition, nutritional risk, cancer
- Medical subject headings
- Neoplasms, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protein supplementDietary supplement
Also called protein
20 gram protein supplement per day
nutrition counselingBehavioural
nutrition counseling for guidance of food intake
| Study group | Role | What they receive |
|---|---|---|
| protein supplements | Experimental | This group will receive dietary guidance and protein supplements for 3 months Receives: Dietary Supplement: protein supplement; Behavioral: nutrition counseling |
| dietary guidance | Other | this group will receive dietary guidance for 3 months Receives: Behavioral: nutrition counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood toxicity
blood toxicity based on Common Terminology Criteria for Adverse Events (CTCAE)
Measured: 6 month
nutritional risk
nutritional risk based on nutrition risk screening-2002 (NRS-2002)
Measured: 6 months
malnutrition
malnutrition assessment based on Global Leadership Initiative on Malnutrition (GLIM)
Measured: 6 months
Secondary outcomes (3)
phase angle (PA)
phase angle (PA) assessed by multi-Bioelectric Impedance Analysis (m-BIA)
Measured: 6 month
weight
weight change during the study
Measured: 6 month
dose limitation
dose limitation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study startApr 2023 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kang Yu, MD, Study director, Peking Union Medical College HospitalFang Wang, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802381
- Sponsor's protocol ID
- protein-malnutrition-cancer
- Status last verified
- Mar 2023
- First submitted
- 27 Mar 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Safety and Effectiveness of Protein Supplements on Cancer Patients With Nutritional Risk and Malnutrition
- ClinicalTrials.gov ID
- NCT05802381
- Acronym / sponsor ID
- protein-malnutrition-cancer
- Conditions
- Cancer, Malnutrition
- Keywords
- protein, malnutrition, nutritional risk, cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 6 Apr 2023 (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.
Nutritional risk and malnutrition is common in cancer patients, which is one of the significant factors affecting the overall survival, toxicity during anticancer treatment, and quality of life among patients with cancer. Previous studies have shown that the increased protein intake can stimulate muscle synthesis, and improve muscle mass, strength, function, overall survival, and quality of life. The current study is going to investigate the effectiveness and safety of protein supplements on patients with cancer, in order to provide a reference for further nutrition treatment.
Detailed description
An anticipated total of 100 participants will randomly assigned to receive either a 20-gram protein supplement per day or nutrition counseling to increase the protein intake. there will be a total of 3 study visits, and dietary assessment and blood sample collection will occur at every study visit. Intention-to-treat analysis (ITT) and per-protocol analysis (PP) will be used in statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| protein supplements | Experimental | Dietary Supplement: protein supplement, Behavioral: nutrition counselingThis group will receive dietary guidance and protein supplements for 3 months |
| dietary guidance | Other | Behavioral: nutrition counselingthis group will receive dietary guidance for 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Age>=18years old;
Key exclusion criteria (6 listed)
- • People who are allergic to whey protein.
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 |
|---|---|---|
| protein supplementAlso: protein20 gram protein supplement per day | Dietary supplement | protein supplements |
| nutrition counselingnutrition counseling for guidance of food intake | Behavioural | dietary guidance, protein supplements |
Primary outcome
blood toxicity
Time frame: 6 month
blood toxicity based on Common Terminology Criteria for Adverse Events (CTCAE)
nutritional risk
Time frame: 6 months
nutritional risk based on nutrition risk screening-2002 (NRS-2002)
malnutrition
Time frame: 6 months
malnutrition assessment based on Global Leadership Initiative on Malnutrition (GLIM)
3 secondary outcomes
phase angle (PA)
Time frame: 6 month
weight
Time frame: 6 month
dose limitation
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Kang Yu, MD study director
Peking Union Medical College Hospital
Fang Wang, MD principal investigator
Peking Union Medical College Hospital
Questions about this trial
What is this clinical trial studying?
A study testing protein supplement and nutrition counseling in people with Cancer and Malnutrition, run by Peking Union Medical College Hospital.
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 6 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: status not confirmed, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kang Yu, MD (+8613801130457, yuk1997@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood toxicity (time frame: 6 month). The study lists 3 primary outcomes in all. 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 6 Apr 2023.