Breast CancerNCT02771756
The Effect of Zhen Qi Shen Capsule Combined With Yu Yi Kang on Breast Cancer and Lung Cancer Patients With Chemotherapy
A study testing zhen qishen capsule and Oral Supplement of Yuyikang, chemotherapy and nutrition education in people with Breast Cancer and Lung Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The purpose of this study is to research more reasonable and safe methods of nutritional support to improve the nutritional status of tumor patients, which guarantees the anti-tumor treatment such as chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Breast Cancer, Lung Cancer
- What is being tested?
- zhen qishen capsule and Oral Supplement of Yuyikang, chemotherapy and nutrition education
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- May 2015to May 2016
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 70 years old
- Breast or lung cancer was diagnosed by pathology or cytology
- ECOG score: 0-2 points
- PG-SGA: 2-8 points, while the weight loss within 3 months less than 5%
- The organ function is good, with chemotherapy index. ANC is equal to or over 1.5 * 10^9/L, PLT is equal to or over 100* 10^9/L, HGB is equal to or over 90g/L
- Bilirubin is equal to or less than 1.5 times of the normal upper limit, AP, AST, ALT is less than or equal to 2 times of normal upper limit
- Ccr is equal to or over 50mL/min
- Life expectancy is equal to or over 12 weeks
Who cannot join
- Complete or incomplete intestinal obstruction
- A severe infection or difficult to control diabetes
- History of organ transplantation, or current use of immunosuppressive agents
- An intervention in nutritional supplements, or a metabolic disorder
- Parenteral nutrition must be applied
- Alcoholism or drug addiction
Show all 10Show fewer
- Pregnancy or lactation, or women of childbearing age refuse contraception
- There are potential factors that interfere with the mental, psychological, family, social or geographical and other factors of the research project
- There are other diseases that may interfere with the results of this study, such as the second primary tumor
- For any other reason, the researchers were unable to complete the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
National Cancer Institute, Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Peng Yuan, MD, 86-10-87788528, Yuanpeng01@hotmail.com
About this study
Official title: Randomized, Self Controlled Study on the Effect of Oral Supplement of Zhen Qi Shen Capsule Combined With Yu Yi Kang on Breast Cancer and Lung Cancer Patients With Chemotherapy
The purpose of this study is to research more reasonable and safe methods of nutritional support to improve the nutritional status of tumor patients, which guarantees the anti-tumor treatment such as chemotherapy.
Read the detailed description
This study is a prospective, randomized, controlled clinical trials. 300 patients were randomly divided into 2 groups for its own control study.
Test group: Zhen qishen capsule (2 capsules, Bid) and Oral Supplement of Yuyikang (50g,Bid), a total of 150 people, are used for 42 days continuously.
Placebo group: Zhen qishen capsule placebo (2 capsules, Bid) and Oral Supplement of Yuyikang placebo (50g, Bid), a total of 150 people, are used for 42 days continuously.
The subjects were randomized to AB or BA parallely, and the two groups were given chemotherapy and nutrition.
- Conditions
- Breast Cancer, Lung Cancer
- Being tested
- zhen qishen capsule and Oral Supplement of Yuyikang, zhen qishen capsule placebo and Oral Supplement of Yuyikang placebo, chemotherapy, nutrition education
- Keywords
- Breast cancer, Lung cancer, Nutritional support, Safety, Effectiveness
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zhen qishen capsule and Oral Supplement of YuyikangDietary supplement
zhen qishen capsule placebo and Oral Supplement of Yuyikang placeboDietary supplement
chemotherapyRadiation
nutrition educationOther
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | Zhen qishen capsule (2 capsules, Bid) and Oral Supplement of Yuyikang (50g, Bid), a total of 150 people, are used for 42 days continuously. Receives: Dietary Supplement: zhen qishen capsule and Oral Supplement of Yuyikang; Radiation: chemotherapy; Other: nutrition education |
| placebo group | Placebo comparator | Zhen qishen capsule placebo (2 capsules, Bid) and Oral Supplement of Yuyikang placebo (50g,Bid), a total of 150 people, are used for 42 days continuously. Receives: Dietary Supplement: zhen qishen capsule placebo and Oral Supplement of Yuyikang placebo; Radiation: chemotherapy; Other: nutrition education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change rate
Measured: 6 weeks and 9 weeks after baseline.
Siderophilin change status
Measured: 6 weeks and 9 weeks after baseline.
Interleukin 1 change status
Measured: 6 weeks and 9 weeks after baseline.
interleukin 6 change status
Measured: 6 weeks and 9 weeks after baseline.
Tumor Necrosis Factor α change status
Measured: 6 weeks and 9 weeks after baseline.
Secondary outcomes (13)
Change status of the Gripping Power
Measured: 6 weeks and 9 weeks after baseline.
Prealbumin Blood Examination change status
Measured: 6 weeks and 9 weeks after baseline.
Albumin change status
Measured: 6 weeks and 9 weeks after baseline.
Total Bilirubin change status
Measured: 6 weeks and 9 weeks after baseline.
Bilirubin Direct change status
Measured: 6 weeks and 9 weeks after baseline.
Indirect Bilirubin change status
Measured: 6 weeks and 9 weeks after baseline.
Alkaline Phosphatase change status
Measured: 6 weeks and 9 weeks after baseline.
Alanine Aminotransferase change status
Measured: 6 weeks and 9 weeks after baseline.
Aspartate Aminotransferase change status
Measured: 6 weeks and 9 weeks after baseline.
Serum Creatinine change status
Measured: 6 weeks and 9 weeks after baseline.
Urine Nitrogen change status
Measured: 6 weeks and 9 weeks after baseline.
Lymphocyte Number change status
Measured: 6 weeks and 9 weeks after baseline.
Hemoglobin change status
Measured: 6 weeks and 9 weeks after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startMay 2015
- Primary completionMay 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Yuan, Chinese Academy of Medical Sciences
- Investigators
- Peng Yuan, MD, Principal investigator, Chief physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771756
- Sponsor's protocol ID
- CH-BC-036
- Status last verified
- May 2016
- First submitted
- 18 Apr 2016
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Self Controlled Study on the Effect of Oral Supplement of Zhen Qi Shen Capsule Combined With Yu Yi Kang on Breast Cancer and Lung Cancer Patients With Chemotherapy
- ClinicalTrials.gov ID
- NCT02771756
- Acronym / sponsor ID
- CH-BC-036
- Conditions
- Breast Cancer, Lung Cancer
- Keywords
- Breast cancer, Lung cancer, Nutritional support, Safety, Effectiveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 13 May 2016 (estimated)
- 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.
The purpose of this study is to research more reasonable and safe methods of nutritional support to improve the nutritional status of tumor patients, which guarantees the anti-tumor treatment such as chemotherapy.
Detailed description
This study is a prospective, randomized, controlled clinical trials. 300 patients were randomly divided into 2 groups for its own control study.
Test group: Zhen qishen capsule (2 capsules, Bid) and Oral Supplement of Yuyikang (50g,Bid), a total of 150 people, are used for 42 days continuously.
Placebo group: Zhen qishen capsule placebo (2 capsules, Bid) and Oral Supplement of Yuyikang placebo (50g, Bid), a total of 150 people, are used for 42 days continuously.
The subjects were randomized to AB or BA parallely, and the two groups were given chemotherapy and nutrition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Dietary Supplement: zhen qishen capsule and Oral Supplement of Yuyikang, Radiation: chemotherapy, Other: nutrition educationZhen qishen capsule (2 capsules, Bid) and Oral Supplement of Yuyikang (50g, Bid), a total of 150 people, are used for 42 days continuously. |
| placebo group | Placebo comparator | Dietary Supplement: zhen qishen capsule placebo and Oral Supplement of Yuyikang placebo, Radiation: chemotherapy, Other: nutrition educationZhen qishen capsule placebo (2 capsules, Bid) and Oral Supplement of Yuyikang placebo (50g,Bid), a total of 150 people, are used for 42 days continuously. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients aged between 18 and 70 years old
- Breast or lung cancer was diagnosed by pathology or cytology
- ECOG score: 0-2 points
- PG-SGA: 2-8 points, while the weight loss within 3 months less than 5%
- The organ function is good, with chemotherapy index. ANC is equal to or over 1.5 * 10^9/L, PLT is equal to or over 100* 10^9/L, HGB is equal to or over 90g/L
Key exclusion criteria (10 listed)
- Complete or incomplete intestinal obstruction
- A severe infection or difficult to control diabetes
- History of organ transplantation, or current use of immunosuppressive agents
- An intervention in nutritional supplements, or a metabolic disorder
- Parenteral nutrition must be applied
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 |
|---|---|---|
| zhen qishen capsule and Oral Supplement of Yuyikang | Dietary supplement | test group |
| zhen qishen capsule placebo and Oral Supplement of Yuyikang placebo | Dietary supplement | placebo group |
| chemotherapy | Radiation | placebo group, test group |
| nutrition education | Other | placebo group, test group |
Primary outcome
Weight change rate
Time frame: 6 weeks and 9 weeks after baseline.
Siderophilin change status
Time frame: 6 weeks and 9 weeks after baseline.
Interleukin 1 change status
Time frame: 6 weeks and 9 weeks after baseline.
interleukin 6 change status
Time frame: 6 weeks and 9 weeks after baseline.
Tumor Necrosis Factor α change status
Time frame: 6 weeks and 9 weeks after baseline.
13 secondary outcomes
Change status of the Gripping Power
Time frame: 6 weeks and 9 weeks after baseline.
Prealbumin Blood Examination change status
Time frame: 6 weeks and 9 weeks after baseline.
Albumin change status
Time frame: 6 weeks and 9 weeks after baseline.
Total Bilirubin change status
Time frame: 6 weeks and 9 weeks after baseline.
Bilirubin Direct change status
Time frame: 6 weeks and 9 weeks after baseline.
Indirect Bilirubin change status
Time frame: 6 weeks and 9 weeks after baseline.
Alkaline Phosphatase change status
Time frame: 6 weeks and 9 weeks after baseline.
Alanine Aminotransferase change status
Time frame: 6 weeks and 9 weeks after baseline.
Aspartate Aminotransferase change status
Time frame: 6 weeks and 9 weeks after baseline.
Serum Creatinine change status
Time frame: 6 weeks and 9 weeks after baseline.
Urine Nitrogen change status
Time frame: 6 weeks and 9 weeks after baseline.
Lymphocyte Number change status
Time frame: 6 weeks and 9 weeks after baseline.
Hemoglobin change status
Time frame: 6 weeks and 9 weeks after baseline.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Individual participant dataSharing planned: Yes
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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.
Peng Yuan, MD principal investigator
Chief physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing zhen qishen capsule and Oral Supplement of Yuyikang, chemotherapy and nutrition education in people with Breast Cancer and Lung Cancer, run by Chinese Academy of Medical Sciences 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 8 inclusion and 10 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 13 May 2016. 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 Peng Yuan, MD (00861087788528, Yuanpeng01@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight change rate (time frame: 6 weeks and 9 weeks after baseline.). The study lists 5 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 13 May 2016.