Cancer CachexiaPhase 4NCT02553187
A Prospective, Randomized, Controlled, Multicenter Study of Kanglaite Injection for the Treatment of Cancer Cachexia
A Phase 4 study testing Kanglaite Injection in people with Cancer Cachexia, run by Zhejiang Kanglaite Pharmaceutical Co.Ltd at 1 site in China.
Trial summary
The purpose of the study is to explore the efficacy and safety of Kanglaite Injection in the treatment of patients with late-stage cancer cachexia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer Cachexia
- What is being tested?
- Kanglaite Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to Jul 2018
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed patients with stage III-IV non-small cell lung cancer (adenocarcinoma), colorectal carcinoma or pancreatic carcinoma, who are not eligible for surgery, interventional treatment and radiation therapy;
- Confirmed patients with cachexia: weight loss greater than 5% in last six months, or BMI<20kg/m2 and weight loss greater than 2%, or in accordance with the diagnosis of sarcopenia and weight loss greater than 2%;
- Patients who are not being treated with chemotherapy should have completed chemotherapy 14 days before randomization of this study;
- For patients who are being treated with chemotherapy, the chemotherapy regimen should be confined to the regimens specified in the protocol; and the chemotherapy regimen, in general, are not allowed to be changed during the study period;
- Patients are conscious and able to cooperate with the doctor to complete the disease-related examinations and evaluations;
- ECOG performance status (PS) 0-3 for those who are not treated with chemotherapy; and ECOG PS 0-2 for those who are being treated with chemotherapy;
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- Expected survival period is more than 4 months;
- Male or female aged 18 - 75 years;
- Patients who are willing to participate in the study and sign the informed consent form.
Who cannot join
- Any pathological type of non-small cell lung cancer (NSCLC) except adenocarcinoma;
- Patients who are being treated with chemotherapy, the chemotherapy regimen is not among the regimens specified in the protocol;
- Patients with cachexia caused by other reasons, e.g. severe hepatic dysfunction [Aspartate transaminase(AST)/Cerealthirdtransaminase(ALT) >5 times the ULN], severe renal dysfunction (Cr >1.5 times the ULN), uncontrolled thyroid disease, New York Heart Association (NYHA) class III-IV heart failure, AIDS etc.;
- Any condition that may hinder the subject's completion of the study, including but not limited to severe uncontrollable organic diseases or infection, unstable angina pectoris, congestive heart failure, etc.;
- Patients who are being treated with other anticancer traditional Chinese medicine (TCM), or those who may be treated with TCM after enrollment;
- Patients with severe hepatic dysfunction: Scr >=1.5 times the ULN, ALT/AST/alkaline phosphatase (ALP) >=5 times the ULN, total bilirubin (TBIL) >=1.5 times the ULN;
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- Patients with severe abnormal lipid metabolism [TC>300mg/dl or Triglyceride(TG) >2.5 times the ULN], or those who are in lipid-lowering therapy;
- Known or suspected diagnosis of metastatic encephaloma;
- In treatment of or plan to receive treatment of molecular targeted drugs, eg,epidermal growth factor receptor
- tyrosine kinase inhibitor (EGFR-TKI), anaplastic lymphoma kinase (ALK) inhibitor, anti-angiogenic agents (including monoclonal antibodies and endostatin), and cetuximab;
- Patients present with an ECOG score>2 and require treatment of chemotherapy;
- Patients with allergies or intolerability to the investigational product or its excipients;
- Patients who are currently included in other clinical trials on antineoplastic drugs;
- Patients who are not able to provide the Informed Consent Form (ICF);
- Expected survival period is less than 4 months;
- Female patient is pregnant or breast-feeding, and those patients at childbearing age who are not willing to use methods of contraception (including males);
- Patients with symptomatic, uncontrolled nervous disorders, mental illness or psychiatric disorder;
- Any condition, in the investigator's opinion, is not in the best interest of the subject (e.g., harming the subject's health) or potentially interferes with the evaluation of treatment according to this protocol.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Center, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Shiying Yu, +8613871382805
About this study
The purpose of the study is to explore the efficacy and safety of Kanglaite Injection in the treatment of patients with late-stage cancer cachexia.
Read the detailed description
The study is a multicenter, prospective, randomized controlled study. The planned sample size is 160 subjects. These subjects will be randomized (1:1) to treatment group (i.e., standard therapy plus Kanglaite Injection) or control group (i.e., standard therapy plus blank control). The study population includes the patients with non small cell lung cancer (adenocarcinoma), colorectal carcinoma and pancreatic carcinoma, who are complicated with cachexia.
- Conditions
- Cancer Cachexia
- Being tested
- Kanglaite Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kanglaite InjectionDrug
Also called Coicis Oil injection
200 mL, slow IV drip, once daily for 14 consecutive days, subsequent courses repeated after a 7-day interval.
Subjects will be treated for 4 courses (12 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Kanglaite Injection plus standard therapy. Receives: Drug: Kanglaite Injection |
| Control group | No intervention | Blank control and standard therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Measured: 77days
Lean body mass
Measured: 77days
Secondary outcomes (10)
Progression-free survival rate (PFS)
Measured: 77days
Eastern Cooperative Oncology Group score (ECOG)
Measured: 77days
Quality of life score (QOL)
Measured: 77days
Survival curve
Measured: 77days
Overall Survival (OS)
Measured: 77days
Body Mass Index (BMI)
Measured: 77days
Serum albumin
Measured: 77days
Serum Prealbumin
Measured: 77days
Serum Lactic Acid
Measured: 77days
Incidence of myelosuppression (%)
Measured: 77days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionJul 2017 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer CachexiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Kanglaite Pharmaceutical Co.Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- H & J CRO International, Inc.
- Responsible party
- Sponsor
- Investigators
- Shiying YU, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02553187
- Sponsor's protocol ID
- KLT201401
- Status last verified
- Feb 2017
- First submitted
- 9 Sep 2015
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled, Multicenter Study of Kanglaite Injection for the Treatment of Cancer Cachexia
- ClinicalTrials.gov ID
- NCT02553187
- Acronym / sponsor ID
- KLT201401
- Conditions
- Cancer Cachexia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Zhejiang Kanglaite Pharmaceutical Co.LtdUniversity, hospital or other
- Collaborators
- H & J CRO International, Inc.
- Study start
- Sep 2015 (actual)
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 17 Sep 2015 (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 the study is to explore the efficacy and safety of Kanglaite Injection in the treatment of patients with late-stage cancer cachexia.
Detailed description
The study is a multicenter, prospective, randomized controlled study. The planned sample size is 160 subjects. These subjects will be randomized (1:1) to treatment group (i.e., standard therapy plus Kanglaite Injection) or control group (i.e., standard therapy plus blank control). The study population includes the patients with non small cell lung cancer (adenocarcinoma), colorectal carcinoma and pancreatic carcinoma, who are complicated with cachexia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Kanglaite InjectionKanglaite Injection plus standard therapy. |
| Control group | No intervention | –Blank control and standard therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed patients with stage III-IV non-small cell lung cancer (adenocarcinoma), colorectal carcinoma or pancreatic carcinoma, who are not eligible for surgery, interventional treatment and radiation therapy;
- Confirmed patients with cachexia: weight loss greater than 5% in last six months, or BMI<20kg/m2 and weight loss greater than 2%, or in accordance with the diagnosis of sarcopenia and weight loss greater than 2%;
- Patients who are not being treated with chemotherapy should have completed chemotherapy 14 days before randomization of this study;
- For patients who are being treated with chemotherapy, the chemotherapy regimen should be confined to the regimens specified in the protocol; and the chemotherapy regimen, in general, are not allowed to be changed during the study period;
- Patients are conscious and able to cooperate with the doctor to complete the disease-related examinations and evaluations;
Key exclusion criteria (18 listed)
- Any pathological type of non-small cell lung cancer (NSCLC) except adenocarcinoma;
- Patients who are being treated with chemotherapy, the chemotherapy regimen is not among the regimens specified in the protocol;
- Patients with cachexia caused by other reasons, e.g. severe hepatic dysfunction [Aspartate transaminase(AST)/Cerealthirdtransaminase(ALT) >5 times the ULN], severe renal dysfunction (Cr >1.5 times the ULN), uncontrolled thyroid disease, New York Heart Association (NYHA) class III-IV heart failure, AIDS etc.;
- Any condition that may hinder the subject's completion of the study, including but not limited to severe uncontrollable organic diseases or infection, unstable angina pectoris, congestive heart failure, etc.;
- Patients who are being treated with other anticancer traditional Chinese medicine (TCM), or those who may be treated with TCM after enrollment;
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 |
|---|---|---|
| Kanglaite InjectionAlso: Coicis Oil injection200 mL, slow IV drip, once daily for 14 consecutive days, subsequent courses repeated after a 7-day interval. Subjects will be treated for 4 courses (12 weeks). | Drug | Treatment group |
Primary outcome
Body weight
Time frame: 77days
Lean body mass
Time frame: 77days
10 secondary outcomes
Progression-free survival rate (PFS)
Time frame: 77days
Eastern Cooperative Oncology Group score (ECOG)
Time frame: 77days
Quality of life score (QOL)
Time frame: 77days
Survival curve
Time frame: 77days
Overall Survival (OS)
Time frame: 77days
Body Mass Index (BMI)
Time frame: 77days
Serum albumin
Time frame: 77days
Serum Prealbumin
Time frame: 77days
Serum Lactic Acid
Time frame: 77days
Incidence of myelosuppression (%)
Time frame: 77days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
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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.
Shiying YU principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Kanglaite Injection in people with Cancer Cachexia, run by Zhejiang Kanglaite Pharmaceutical Co.Ltd 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 9 inclusion and 18 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 15 Feb 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Shiying YU (+8613871382805, syyu@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: 77days). The study lists 2 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 15 Feb 2017.