Lung CancerNCT05771207
Effects of Protein on Muscle, Gut Microbiota and Clinical Outcome in Patients With Lung Cancer-related Sarcopenia
A study testing soy protein and whey protein in people with Lung Cancer and Sarcopenia, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Sarcopenia is common in lung cancer patients. It is one of the significant factors affecting the overall survival, radiotherapy and chemotherapy efficacy, and quality of life of patients with lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Sarcopenia
- What is being tested?
- soy protein and whey protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Mar 2023to Jan 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
- Patients with lung cancer and sarcopenia
- ECOG<=2
- Patients are able to provide written informed consent.
Who cannot join
- People who are allergic to soy protein and whey protein.
- Participants received any drugs or supplements known to influence effcet size, such as protein powder, anabolic steroids, or glucorticosteroid before the 3 months preceding the study.
- Participants with gastrointestinal bleeding, enterotomy or gastric bypass surgery before the 3 months preceding the study.
- Concurrent severe cardiac disease, liver and renal failure, which may significantly interfere with study compliance.
- Participants with electronic or mental device.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Effects of Soy Protein and Whey Protein on Muscle, Gut Microbiota and Clinical Outcome in Patients With Lung Cancer-related Sarcopenia（LCRS）: a Randomized, Double-blind, Controlled Clinical Study
Sarcopenia is common in lung cancer patients. It is one of the significant factors affecting the overall survival, radiotherapy and chemotherapy efficacy, and quality of life of patients with lung cancer. Previous studies have shown that increased protein intake can stimulate postprandial muscle synthesis, and improve muscle mass, strength, function, and overall survival. However, most previous studies have focused on the intervention of whey protein, while the protective effect of soybean protein on lung cancer-related sarcopenia (LCRS) has not yet been fully explored and reached an agreement.
So, this study aims to explore the effects of soy and whey protein on muscle, gut microbiota, and clinical outcomes among patients with lung cancer-related sarcopenia, to provide a reference for further nutrition treatment.
Read the detailed description
This study will last 6 months. For the duration of the study, an anticipated total of 90 participants will be randomly assigned to receive either a 30-gram protein supplement or a placebo daily. There will be a total of 5 study visits, and dietary records, questionnaires, blood and stool collection, and functional testing will occur at all study visits. Intention-to-treat analysis (ITT) and per-protocol analysis (PP) will be conducted in statistical analysis.
- Conditions
- Lung Cancer, Sarcopenia
- Being tested
- soy protein, whey protein, placebo
- Keywords
- soy protein, whey protein, lung cancer related sarcopenia
- Medical subject headings
- Lung Neoplasms, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soy proteinDietary supplement
The intervention is made up of soy protein supplements (30g/d) and dietary pattern modification.
whey proteinDietary supplement
The intervention is made up of whey protein supplements (30g/d) and dietary pattern modification.
placeboDietary supplement
The intervention is made up of maltodextrin (30g/d) and dietary pattern modification.
| Study group | Role | What they receive |
|---|---|---|
| soy protein intervention | Experimental | This group received dietary guidance and soy protein intervention for 3 months Receives: Dietary Supplement: soy protein |
| whey protein intervention | Experimental | This group received dietary guidance and whey protein intervention for 3 months Receives: Dietary Supplement: whey protein |
| control | Placebo comparator | This group received dietary guidance and ｍltodextrin for 3 months Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Appendicular skeletal muscle mass index at 3 months
Defined as muscle mass (Unit: kg/m2)
Measured: 3 months
Secondary outcomes (7)
Change from Baseline Hand grip at 3 months
Defined as muscle strength (Unit: kg)
Measured: 3 months
Change from Baseline physical performance Baseline at 3 months
Measured by Short Physical Performance Battery (0-12) with higher scores meaning better physical performance.
Measured: 3 months
Change from Baseline Physical function at 3 months
Measured by FRAIL scale (0-5) with higher scores meaning better physical function.
Measured: 3 months
Change from Baseline Quality of life questionnaire at 3 months
Measured by EuroQol- 5 Dimension scale (0-5) with higher scores meaning better Quality of life.
Measured: 3 months
Change from Baseline gut microbiota composition at 3 months
The stool samples of participants before and after intervention were collected and analized by 16S rRNA.
Measured: 3 months
Number of patients with good Chemotherapy Tolerance
Completing initially planned chemotherapy course is defined as good tolerance; dose adjustment, delayed completion or interruption of treatment are considered as poor tolerance.
Measured: 3 months
Incidence of Chemotherapy toxicity
Measured after initiation of chemotherapy using the WHO Toxicity Grades (gradeI-IV) with higher grades neaning severer chemotheraphy toxicity.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study startMar 2023 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Kang, MD, Peking Union Medical College Hospital
- Investigators
- Kang Yu, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771207
- Sponsor's protocol ID
- protein-cancer-sarcopenia2023
- Status last verified
- Mar 2023
- First submitted
- 23 Feb 2023
- Last updated
- 16 Mar 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 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Soy Protein and Whey Protein on Muscle, Gut Microbiota and Clinical Outcome in Patients With Lung Cancer-related Sarcopenia（LCRS）: a Randomized, Double-blind, Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT05771207
- Acronym / sponsor ID
- protein-cancer-sarcopenia2023
- Conditions
- Lung Cancer, Sarcopenia
- Keywords
- soy protein, whey protein, lung cancer related sarcopenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 16 Mar 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.
Sarcopenia is common in lung cancer patients. It is one of the significant factors affecting the overall survival, radiotherapy and chemotherapy efficacy, and quality of life of patients with lung cancer. Previous studies have shown that increased protein intake can stimulate postprandial muscle synthesis, and improve muscle mass, strength, function, and overall survival. However, most previous studies have focused on the intervention of whey protein, while the protective effect of soybean protein on lung cancer-related sarcopenia (LCRS) has not yet been fully explored and reached an agreement.
So, this study aims to explore the effects of soy and whey protein on muscle, gut microbiota, and clinical outcomes among patients with lung cancer-related sarcopenia, to provide a reference for further nutrition treatment.
Detailed description
This study will last 6 months. For the duration of the study, an anticipated total of 90 participants will be randomly assigned to receive either a 30-gram protein supplement or a placebo daily. There will be a total of 5 study visits, and dietary records, questionnaires, blood and stool collection, and functional testing will occur at all study visits. Intention-to-treat analysis (ITT) and per-protocol analysis (PP) will be conducted in statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| soy protein intervention | Experimental | Dietary Supplement: soy proteinThis group received dietary guidance and soy protein intervention for 3 months |
| whey protein intervention | Experimental | Dietary Supplement: whey proteinThis group received dietary guidance and whey protein intervention for 3 months |
| control | Placebo comparator | Dietary Supplement: placeboThis group received dietary guidance and ｍltodextrin 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
- Patients with lung cancer and sarcopenia
- ECOG<=2
- Patients are able to provide written informed consent.
Key exclusion criteria (5 listed)
- People who are allergic to soy protein and whey protein.
- Participants received any drugs or supplements known to influence effcet size, such as protein powder, anabolic steroids, or glucorticosteroid before the 3 months preceding the study.
- Participants with gastrointestinal bleeding, enterotomy or gastric bypass surgery before the 3 months preceding the study.
- Concurrent severe cardiac disease, liver and renal failure, which may significantly interfere with study compliance.
- Participants with electronic or mental device.
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 |
|---|---|---|
| soy proteinThe intervention is made up of soy protein supplements (30g/d) and dietary pattern modification. | Dietary supplement | soy protein intervention |
| whey proteinThe intervention is made up of whey protein supplements (30g/d) and dietary pattern modification. | Dietary supplement | whey protein intervention |
| placeboThe intervention is made up of maltodextrin (30g/d) and dietary pattern modification. | Dietary supplement | control |
Primary outcome
Change from Baseline Appendicular skeletal muscle mass index at 3 months
Time frame: 3 months
Defined as muscle mass (Unit: kg/m2)
7 secondary outcomes
Change from Baseline Hand grip at 3 months
Time frame: 3 months
Change from Baseline physical performance Baseline at 3 months
Time frame: 3 months
Change from Baseline Physical function at 3 months
Time frame: 3 months
Change from Baseline Quality of life questionnaire at 3 months
Time frame: 3 months
Change from Baseline gut microbiota composition at 3 months
Time frame: 3 months
Number of patients with good Chemotherapy Tolerance
Time frame: 3 months
Incidence of Chemotherapy toxicity
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 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 principal investigator
Peking Union Medical College 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 soy protein and whey protein in people with Lung Cancer and Sarcopenia, run by Peking Union Medical College Hospital 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: status not confirmed, as of the sponsor's last update on 16 Mar 2023. 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. Some participants in this study may receive a placebo. 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?
Change from Baseline Appendicular skeletal muscle mass index at 3 months (time frame: 3 months). 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 16 Mar 2023.