Cancer-related Problem/ConditionNCT02468141
Effect of Sipjeondaebo-tang for Cancer Related Anorexia in Cancer Patients
A study testing SJDBT in people with Cancer-related Problem/Condition, run by Kyunghee University Medical Center at 1 site in South Korea.
Trial summary
To determine efficacy and safety of Sipjeondaebo-tang for Cancer patients suffering from anorexia after chemotherapy. Sipjeondaebo-tang will be administered for 4 weeks, 3 times per day after a meal. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Cancer-related Problem/Condition
- What is being tested?
- SJDBT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2015to Sep 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ages 20 to 80 years
- Individuals who are suffering from cancer-associated anorexia
- Patients within 1 month after completion of chemotherapy
- No plan for additional chemotherapy or radiotherapy
- Anorexia visual analogue scale (VAS) ≥ 40/100mm
- Qi deficiency scale ≥ 30 or Blood deficiency scale ≥ 30
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- Neutrophil ≥ 1,500/㎕, platelet ≥ 100,000/㎕
- Total bilirubin lower than upper limit of normal (1.2 mg/㎗)
- ALT, AST lower than 2-fold the upper limit of normal
- Creatinine lower than 1.5 fold the upper limit of normal(1.09 mg/㎗)
- Written informed consent for participation in the trial
Who cannot join
- Patient impossible to oral intake
- Patient 5 years after cancer diagnosis
- ECOG performance status score > 3
- Patient with dementia, delirium, depression
- Patient who complain of more than 7 points when we use Numeric Rating Scale, which can affect appetite or calorie intake, within 2 weeks of screening
- Patient with diseases which can influence on appetite (such as hypoadrenalism, etc)
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- Patient who are taking appetizers (such as megestrol acetate, corticosteroids, thalidomide)
- Women who has possibility of a pregnancy
- Others who are judged not to be appropriate to study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Sipjeondaebo-tang for Cancer Related Anorexia in Cancer Patients: A Randomized Double Blinded Placebo Controlled Pilot Study
To determine efficacy and safety of Sipjeondaebo-tang for Cancer patients suffering from anorexia after chemotherapy. Sipjeondaebo-tang will be administered for 4 weeks, 3 times per day after a meal. Changes of FAACT scale, Anorexia VAS, Weight, BMI, Clinical laboratory test such as ACTH, Cortisol, Chrelin, IL-6, ESR, CRP will be measured and analyzed.
- Conditions
- Cancer-related Problem/Condition
- Being tested
- SJDBT, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SJDBTDrug
Also called Sipjeondaebotang
Sipjeondaebo-tang
PlaceboDrug
Also called Placebo control
Placebo
| Study group | Role | What they receive |
|---|---|---|
| SJDBT group | Experimental | Herbal medicine Receives: Drug: SJDBT |
| Placebo | Placebo comparator | Placebo control Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Functional Assessment of Anorexia/Cachexia Therapy - Anorexia Cachexia Subscale
Function scores as measured by the likert scale
Measured: 4 weeks
Secondary outcomes (1)
FAACT scale
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionJun 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cancer-related Problem/ConditionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyunghee University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seong-Gyu Ko, Kyunghee University Medical Center
- Investigators
- Chunhoo Cheon, Master, Study director, Institute of Safety and Efficiency Evaluation for Korean Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02468141
- Sponsor's protocol ID
- KCRD_SJDBT_2015
- Status last verified
- Jul 2017
- First submitted
- 27 May 2015
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cheon C, Yoo JE, Yoo HS, Cho CK, Kang S, Kim M, Jang BH, Shin YC, Ko SG. Efficacy and Safety of Sipjeondaebo-Tang for Anorexia in Patients with Cancer: A Pilot, Randomized, Double-Blind, Placebo-Controlled Trial. Evid Based Complement Alternat Med. 2017;2017:8780325. doi: 10.1155/2017/8780325. Epub 2017 Dec 26.
PubMed 29441116Cheon C, Park S, Park YL, Huang CW, Ko Y, Jang BH, Shin YC, Ko SG. Sipjeondaebo-tang in patients with cancer with anorexia: a protocol for a pilot, randomised, controlled trial. BMJ Open. 2016 May 12;6(5):e011212. doi: 10.1136/bmjopen-2016-011212.
PubMed 27173813
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sipjeondaebo-tang for Cancer Related Anorexia in Cancer Patients: A Randomized Double Blinded Placebo Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT02468141
- Acronym / sponsor ID
- KCRD_SJDBT_2015
- Conditions
- Cancer-related Problem/Condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Kyunghee University Medical CenterUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 10 Jun 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.
To determine efficacy and safety of Sipjeondaebo-tang for Cancer patients suffering from anorexia after chemotherapy. Sipjeondaebo-tang will be administered for 4 weeks, 3 times per day after a meal. Changes of FAACT scale, Anorexia VAS, Weight, BMI, Clinical laboratory test such as ACTH, Cortisol, Chrelin, IL-6, ESR, CRP will be measured and analyzed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SJDBT group | Experimental | Drug: SJDBTHerbal medicine |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo control |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Men and women ages 20 to 80 years
- Individuals who are suffering from cancer-associated anorexia
- Patients within 1 month after completion of chemotherapy
- No plan for additional chemotherapy or radiotherapy
- Anorexia visual analogue scale (VAS) ≥ 40/100mm
Key exclusion criteria (9 listed)
- Patient impossible to oral intake
- Patient 5 years after cancer diagnosis
- ECOG performance status score > 3
- Patient with dementia, delirium, depression
- Patient who complain of more than 7 points when we use Numeric Rating Scale, which can affect appetite or calorie intake, within 2 weeks of screening
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 |
|---|---|---|
| SJDBTAlso: SipjeondaebotangSipjeondaebo-tang | Drug | SJDBT group |
| PlaceboAlso: Placebo controlPlacebo | Drug | Placebo |
Primary outcome
The Functional Assessment of Anorexia/Cachexia Therapy - Anorexia Cachexia Subscale
Time frame: 4 weeks
Function scores as measured by the likert scale
1 secondary outcome
FAACT scale
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Derived from this study: PubMed 29441116Cheon C, Yoo JE, Yoo HS, Cho CK, Kang S, Kim M, Jang BH, Shin YC, Ko SG. Efficacy and Safety of Sipjeondaebo-Tang for Anorexia in Patients with Cancer: A Pilot, Randomized, Double-Blind, Placebo-Controlled Trial. Evid Based Complement Alternat Med. 2017;2017:8780325. doi: 10.1155/2017/8780325. Epub 2017 Dec 26.
- Derived from this study: PubMed 27173813Cheon C, Park S, Park YL, Huang CW, Ko Y, Jang BH, Shin YC, Ko SG. Sipjeondaebo-tang in patients with cancer with anorexia: a protocol for a pilot, randomised, controlled trial. BMJ Open. 2016 May 12;6(5):e011212. doi: 10.1136/bmjopen-2016-011212.
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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.
Chunhoo Cheon, Master study director
Institute of Safety and Efficiency Evaluation for Korean Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SJDBT in people with Cancer-related Problem/Condition, run by Kyunghee University Medical Center at 1 site in South Korea.
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 11 inclusion and 9 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: finished, as of the sponsor's last update on 21 Jul 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Functional Assessment of Anorexia/Cachexia Therapy - Anorexia Cachexia Subscale (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02468141, which also lists 2 linked publications.
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 Jul 2017.