Cancer CachexiaNCT03631459
A Multicenter Real World Study of Kanglaite for Cancer Cachexia
An observational study of Cancer Cachexia, run by Zhejiang Kanglaite Pharmaceutical Co.Ltd at 2 sites in China.
Trial summary
A prospective, multi-center real-world study of the effectiveness and safety of Kanglaita Injection/Capsule in Chinese patients with cancer cachexia Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer Cachexia
- What is being tested?
- Kanglaite Injection/Capsules
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 100,000 participants
- Where
- 2 sitesChina
- Study dates
- 20 Aug 2018to 20 Jul 2020
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients meeting international diagnostic criteria for cachexia: 1. Weight loss > 5% over past 6 months or 2. BMI<20 kg/m2 and weight loss > 2% or 3. Sarcopenia and weight loss >2%;
Who may be able to join
- Patients with pathological or cytological diagnosis of lung, liver, pancreatic or stomach cancer; Patients scheduled to receive Kanglaite injection for 7 or more days, followed by Kanglaite capsule for 14 or more days; Patients willing to participate in this study and provide written informed consent.
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
China2 sites
Peking University International Hospital
Beijing, Beijing Municipality, 102206
Jun Liang, MD, +86-010-69006900, liangjun1959@aliyun.com
NanJing PLA 81 Hospital
Nanjing, Jiangsu, 210002
Shukui Qin, MD, +86-025-84453932, qinsk@csco.org.cn
About this study
Official title: Safety and Effectiveness of Kanglaite Injection/Capsules for Treatment of Cancer Cachexia: A Prospective, Multicenter Real World Study of a Large Cohort of Chinese Patients
A prospective, multi-center real-world study of the effectiveness and safety of Kanglaita Injection/Capsule in Chinese patients with cancer cachexia
Read the detailed description
This is a large national-based prospective, multi-center real-world observational study. Cancer cachexia patients scheduled for sequential treatment with Kanglaite injection and capsule between August 2018 and March 2020 at 640 participating hospitals will be recruited to evaluate the effectiveness and safety of Kanglaite.
- Conditions
- Cancer Cachexia
- Being tested
- Kanglaite Injection/Capsules
- Keywords
- Kanglaita Injection/Capsule, Cancer cachexia, Real-world evidences, Overall survival
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kanglaite Injection/CapsulesDrug
Also called Coicis oil injection, Z10970091, Coix seed oil triglyceride, 03004812Z
Kanglaite injection 200 mL, iv. gtt qd×7d or more, followed by Kanglaite capsule 0.45g×6 tablets qid po×14d as one cycle for at least 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| Kanglaite Injection/Capsules | Kanglaite injection 200ml, iv. gtt qd×7d or more, followed by Kanglaite capsule 0.45g×6 tablets qid po×14d as one cycle for at least 4 cycles Receives: Drug: Kanglaite Injection/Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival
Measured: 2018 - 2020
Secondary outcomes (10)
Lean body mass
Lean body mass
Measured: 2018 - 2020
Body weight
Body weight
Measured: 2018 - 2020
Grade of cachexia
Grade of cachexia
Measured: 2018 - 2020
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire QLQ-C30
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire QLQ-C30: 30 items, including functioning, symptoms, and overall health. min: 0, max: 100. The higher values indicate higher level of functioning and quality of life
Measured: 2018 - 2020
Karnofsky performance status
Karnofsky performance status
Measured: 2018 - 2020
Patient-generated subjective global assessment (PG-SGA)
Patient-generated subjective global assessment (PG-SGA)
Measured: 2018 - 2020
Numeric rating scale for pain
Numeric rating scale for pain min: 0; max: 10. The higher values indicate worse pain.
Measured: 2018 - 2020
Numeric rating scale for appetite
Numeric rating scale for appetite min: 0; max: 10. The higher values indicate worse appetite
Measured: 2018 - 2020
Synergistic antitumor effect: Overall response rate
Synergistic antitumor effect: Overall response rate
Measured: 2018 - 2020
Synergistic antitumor effect: Disease control rate
Synergistic antitumor effect: Disease control rate
Measured: 2018 - 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start20 Aug 2018 (estimated)
- Primary completion20 Mar 2020 (estimated)
- Study completion20 Jul 2020 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Kanglaite Pharmaceutical Co.Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- NanJing PLA 81 Hospital, LinkDoc Technology (Beijing) Co. Ltd.
- Responsible party
- Sponsor
- Investigators
- Shukui Qin, MD, Principal investigator, NanJing PLA 81 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03631459
- Sponsor's protocol ID
- KLT-2018
- Status last verified
- Aug 2018
- First submitted
- 12 Aug 2018
- Last updated
- 21 Aug 2018
- 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 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Kanglaite Injection/Capsules for Treatment of Cancer Cachexia: A Prospective, Multicenter Real World Study of a Large Cohort of Chinese Patients
- ClinicalTrials.gov ID
- NCT03631459
- Acronym / sponsor ID
- KLT-2018
- Conditions
- Cancer Cachexia
- Keywords
- Kanglaita Injection/Capsule, Cancer cachexia, Real-world evidences, Overall survival
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Zhejiang Kanglaite Pharmaceutical Co.LtdUniversity, hospital or other
- Collaborators
- NanJing PLA 81 Hospital, LinkDoc Technology (Beijing) Co. Ltd.
- Study start
- 20 Aug 2018 (estimated)
- Primary completion
- 20 Mar 2020 (estimated)
- Study completion
- 20 Jul 2020 (estimated)
- First posted
- 15 Aug 2018 (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.
A prospective, multi-center real-world study of the effectiveness and safety of Kanglaita Injection/Capsule in Chinese patients with cancer cachexia
Detailed description
This is a large national-based prospective, multi-center real-world observational study. Cancer cachexia patients scheduled for sequential treatment with Kanglaite injection and capsule between August 2018 and March 2020 at 640 participating hospitals will be recruited to evaluate the effectiveness and safety of Kanglaite.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kanglaite Injection/Capsules | – | Drug: Kanglaite Injection/CapsulesKanglaite injection 200ml, iv. gtt qd×7d or more, followed by Kanglaite capsule 0.45g×6 tablets qid po×14d as one cycle for at least 4 cycles |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients meeting international diagnostic criteria for cachexia: 1. Weight loss > 5% over past 6 months or 2. BMI<20 kg/m2 and weight loss > 2% or 3. Sarcopenia and weight loss >2%;
Key inclusion criteria (1 listed)
- Patients with pathological or cytological diagnosis of lung, liver, pancreatic or stomach cancer; Patients scheduled to receive Kanglaite injection for 7 or more days, followed by Kanglaite capsule for 14 or more days; Patients willing to participate in this study and provide written informed consent.
Key exclusion criteria (1 listed)
- None
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 Injection/CapsulesAlso: Coicis oil injection, Z10970091, Coix seed oil triglyceride, 03004812ZKanglaite injection 200 mL, iv. gtt qd×7d or more, followed by Kanglaite capsule 0.45g×6 tablets qid po×14d as one cycle for at least 4 cycles | Drug | Kanglaite Injection/Capsules |
Primary outcome
Overall survival
Time frame: 2018 - 2020
Overall survival
10 secondary outcomes
Lean body mass
Time frame: 2018 - 2020
Body weight
Time frame: 2018 - 2020
Grade of cachexia
Time frame: 2018 - 2020
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire QLQ-C30
Time frame: 2018 - 2020
Karnofsky performance status
Time frame: 2018 - 2020
Patient-generated subjective global assessment (PG-SGA)
Time frame: 2018 - 2020
Numeric rating scale for pain
Time frame: 2018 - 2020
Numeric rating scale for appetite
Time frame: 2018 - 2020
Synergistic antitumor effect: Overall response rate
Time frame: 2018 - 2020
Synergistic antitumor effect: Disease control rate
Time frame: 2018 - 2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
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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.
Shukui Qin, MD principal investigator
NanJing PLA 81 Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Cachexia, run by Zhejiang Kanglaite Pharmaceutical Co.Ltd at 2 sites 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 1 inclusion and 1 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 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shukui Qin, MD (0086-025-84453932, qinsk@csco.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 2018 - 2020). 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 21 Aug 2018.