Breast CancerEPCNCT03847623
Effect of Preoperative Curcumin in Breast Cancer Patients
A study testing Curcumin in people with Breast Cancer, run by University of Malaya at 1 site in Malaysia.
Trial summary
Effect of curcumin on modulation of immune and inflammatory parameters in pre-operative patients Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Curcumin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteMalaysia
- Study dates
- 18 Jun 2017to 31 Dec 2020
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with operable breast cancer
- Life expectancy of at least 3 months
- Adequate organ function
- No allergy to curcumin
- Provides consent to participate in trial and adhere to the study protocol
Who cannot join
- Receiving concomitant radiotherapy, hormonal, immune therapy or other investigational drugs
- Uncontrolled concurrent illness
- Patient of anti platelet medications
- Pregnant / breast feeding
- Patients who are unable or unwilling to take curcumin, herbal remedies, or non-prescription medications
- Patients with bleeding tendency, bleeding disorders and abnormal bleeding/clotting profile
Trial locations and contacts
1 site in 1 country.
About this study
Effect of curcumin on modulation of immune and inflammatory parameters in pre-operative patients
Read the detailed description
Patients diagnosed with breast cancer will be supplemented with either curcumin or placebo for a minimum period of 2 weeks and may be extended up to 4 weeks prior to their surgery.
- Conditions
- Breast Cancer
- Being tested
- Curcumin, Placebo
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDietary supplement
Natural compound, active ingredient of turmeric, in bi-daily dosing
PlaceboOther
Placebo tablets at bi-daily dosing
| Study group | Role | What they receive |
|---|---|---|
| Curcumin | Experimental | Capsules, taken orally, 8g per day (Bi-daily dosing) Receives: Dietary Supplement: Curcumin |
| Placebo | Placebo comparator | Capsules, taken orally, bi-daily dosing Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumour infiltrating lymphocytes (TILs)
Scoring as per recommendations by International Immuno-Oncology Biomarker Working Group
Measured: For 2 to 4 weeks
Secondary outcomes (2)
FOXP3
Immunohistochemistry analysis
Measured: For 2 to 4 weeks
CD68
Immunohistochemistry analysis
Measured: For 2 to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start18 Jun 2017
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (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.
- More trials run by University of MalayaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nur Aishah Mohd Taib, University of Malaya
- Investigators
- Nur Aishah Taib, MBBS, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03847623
- Sponsor's protocol ID
- 20149-582
- Acronym
- EPC
- Status last verified
- Mar 2020
- First submitted
- 14 Feb 2019
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Curcumin in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT03847623
- Acronym / sponsor ID
- EPC / 20149-582
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 18 Jun 2017 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 20 Feb 2019 (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.
Effect of curcumin on modulation of immune and inflammatory parameters in pre-operative patients
Detailed description
Patients diagnosed with breast cancer will be supplemented with either curcumin or placebo for a minimum period of 2 weeks and may be extended up to 4 weeks prior to their surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Curcumin | Experimental | Dietary Supplement: CurcuminCapsules, taken orally, 8g per day (Bi-daily dosing) |
| Placebo | Placebo comparator | Other: PlaceboCapsules, taken orally, bi-daily dosing |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with operable breast cancer
- Life expectancy of at least 3 months
- Adequate organ function
- No allergy to curcumin
- Provides consent to participate in trial and adhere to the study protocol
Key exclusion criteria (6 listed)
- Receiving concomitant radiotherapy, hormonal, immune therapy or other investigational drugs
- Uncontrolled concurrent illness
- Patient of anti platelet medications
- Pregnant / breast feeding
- Patients who are unable or unwilling to take curcumin, herbal remedies, or non-prescription medications
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 |
|---|---|---|
| CurcuminNatural compound, active ingredient of turmeric, in bi-daily dosing | Dietary supplement | Curcumin |
| PlaceboPlacebo tablets at bi-daily dosing | Other | Placebo |
Primary outcome
Tumour infiltrating lymphocytes (TILs)
Time frame: For 2 to 4 weeks
Scoring as per recommendations by International Immuno-Oncology Biomarker Working Group
2 secondary outcomes
FOXP3
Time frame: For 2 to 4 weeks
CD68
Time frame: For 2 to 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
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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.
Nur Aishah Taib, MBBS principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curcumin in people with Breast Cancer, run by University of Malaya at 1 site in Malaysia.
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 5 inclusion and 6 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 25 Mar 2020. 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 Malaysia. 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?
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?
Tumour infiltrating lymphocytes (TILs) (time frame: For 2 to 4 weeks). 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 25 Mar 2020.