Breast CarcinomaNCT02858856
Clinical Trial of Sipjeondaebo-tang on Fatigue of Breast Cancer Patients
A study testing Sipjeondaebo-tang in people with Breast Carcinoma, run by Kyunghee University Medical Center at 1 site in South Korea.
Trial summary
This is a pilot study that investigate efficacy and safety of Sipjeondaebo-tang on fatigue of patients with breast carcinoma receiving chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- Sipjeondaebo-tang
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Mar 2017to Jun 2018
- 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
- men and women aged over 18 years
- patients who have histologically or cytologically confirmed breast tumor
- patients who applicable AC(doxorubicin + cyclophosphamide)
- ECOG score 0 to 2
Who cannot join
- patient impossible to orally intake
- patient with dementia, delirium and depression
- patient suffering from diseases like chronic hepatitis B, C or hepatocirrhosis
- severe liver disability (3-fold the normal high range value for ALT, AST)
- patient who has diabetes not controlled by diet, hypertension, hyperthyroidism,
- severe systemic disease
Show all 9Show fewer
- use of other investigational products within the past 30 days
- hypersensitivity to investigational product
- others who are judged not to be appropriate to study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
International St. Mary's Hospital
Incheon, 22711
CHUNHOO CHEON, M.D.(DKM), 82-2-961-9278, hreedom35@gmail.com
About this study
Official title: Sipjeondaebo-tang for Alleviating Fatigue Measured by Brief Fatigue Inventory and EORTC-QLQ-C30, BR23 Score Change Among Patients With Breast Carcinoma Receiving Chemotherapy
This is a pilot study that investigate efficacy and safety of Sipjeondaebo-tang on fatigue of patients with breast carcinoma receiving chemotherapy.
- Conditions
- Breast Carcinoma
- Being tested
- Sipjeondaebo-tang
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sipjeondaebo-tangDrug
Also called Deciten granule
Herbal medicine which is a compound of 10 herbs.
| Study group | Role | What they receive |
|---|---|---|
| A group | Experimental | Take Sipjeondaebo-tang on 0~2 week, 3~5 week of clinical trial period, total of 4 weeks Receives: Drug: Sipjeondaebo-tang |
| B group | Experimental | Take Sipjeondaebo-tang on 6~8 week, 9~11 week of clinical trial period, total of 4 weeks Receives: Drug: Sipjeondaebo-tang |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Fatigue Inventory change
Measured: 0-5 week
Brief Fatigue Inventory change
Measured: 6-11 week
Secondary outcomes (2)
EORTC-QLQ-C30 change
Measured: 0-5 week, 6-11 week
EORTC-QLQ-BR23 change
Measured: 0-5 week, 6-11 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study start20 Mar 2017
- Primary completionMar 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CarcinomaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyunghee University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Catholic Kwandong University
- Responsible party
- Principal investigator, Seong-Gyu Ko, Kyunghee University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02858856
- Sponsor's protocol ID
- ISEE_2016_SJDBT
- Status last verified
- Sep 2017
- First submitted
- 30 Jul 2016
- Last updated
- 15 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheon C, Kang S, Ko Y, Kim M, Jang BH, Shin YC, Ko SG. Sipjeondaebo-tang in patients with breast cancer with fatigue: a protocol for a pilot, randomised, double-blind, placebo-controlled, cross-over trial. BMJ Open. 2018 Jul 6;8(7):e021242. doi: 10.1136/bmjopen-2017-021242.
PubMed 29982213
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sipjeondaebo-tang for Alleviating Fatigue Measured by Brief Fatigue Inventory and EORTC-QLQ-C30, BR23 Score Change Among Patients With Breast Carcinoma Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT02858856
- Acronym / sponsor ID
- ISEE_2016_SJDBT
- Conditions
- Breast Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Kyunghee University Medical CenterUniversity, hospital or other
- Collaborators
- Catholic Kwandong University
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 8 Aug 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.
This is a pilot study that investigate efficacy and safety of Sipjeondaebo-tang on fatigue of patients with breast carcinoma receiving chemotherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A group | Experimental | Drug: Sipjeondaebo-tangTake Sipjeondaebo-tang on 0~2 week, 3~5 week of clinical trial period, total of 4 weeks |
| B group | Experimental | Drug: Sipjeondaebo-tangTake Sipjeondaebo-tang on 6~8 week, 9~11 week of clinical trial period, total of 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- men and women aged over 18 years
- patients who have histologically or cytologically confirmed breast tumor
- patients who applicable AC(doxorubicin + cyclophosphamide)
- ECOG score 0 to 2
Key exclusion criteria (9 listed)
- patient impossible to orally intake
- patient with dementia, delirium and depression
- patient suffering from diseases like chronic hepatitis B, C or hepatocirrhosis
- severe liver disability (3-fold the normal high range value for ALT, AST)
- patient who has diabetes not controlled by diet, hypertension, hyperthyroidism,
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 |
|---|---|---|
| Sipjeondaebo-tangAlso: Deciten granuleHerbal medicine which is a compound of 10 herbs. | Drug | A group, B group |
Primary outcome
Brief Fatigue Inventory change
Time frame: 0-5 week
Brief Fatigue Inventory change
Time frame: 6-11 week
2 secondary outcomes
EORTC-QLQ-C30 change
Time frame: 0-5 week, 6-11 week
EORTC-QLQ-BR23 change
Time frame: 0-5 week, 6-11 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
- Derived from this study: PubMed 29982213Cheon C, Kang S, Ko Y, Kim M, Jang BH, Shin YC, Ko SG. Sipjeondaebo-tang in patients with breast cancer with fatigue: a protocol for a pilot, randomised, double-blind, placebo-controlled, cross-over trial. BMJ Open. 2018 Jul 6;8(7):e021242. doi: 10.1136/bmjopen-2017-021242.
- Individual participant dataSharing planned: No
Related trials for Breast Carcinoma
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sipjeondaebo-tang in people with Breast Carcinoma, 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 4 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: status not confirmed, as of the sponsor's last update on 15 Sep 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. 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 Chunhoo Cheon (8229619278, khuksg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Fatigue Inventory change (time frame: 0-5 week). 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?
On the ClinicalTrials.gov record for NCT02858856, which also lists 1 linked publication.
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 Sep 2017.