Breast CancerProtECtionNCT05504148
Protection of Cardiovascular Function With Crocin in BrEast Cancer Patients Undergoing Radiotherapy and Chemotherapy
A study testing crocin in people with Breast Cancer, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
The potential cardiovascular toxicity of tumor treatment and its resulting cardiovascular events have gradually become an important health risk for tumor survivors. Prevention and early identification of cardiovascular toxicity has now become one of the bottlenecks in improving the prognosis of cancer patients. Read more about this study
- Who is it for?
- Ages 25 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- crocin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 29 Mar 2021to 25 Sep 2023
- 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 25 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 25-80 years old, female;
- Patients diagnosed with breast cancer by histopathology;
- Patients who plan to receive adjuvant radiotherapy/chemotherapy or combined adjuvant trastuzumab or pertuzumab targeted therapy;
- Patients who completed at least 6 cycles of treatment after enrollment;
Who cannot join
- pregnant or breastfeeding women;
- Patients with poor echocardiographic image quality;
- Persistent atrial fibrillation and severe arrhythmia affect the collection and analysis of ultrasound data;
- Patients who are participating in other clinical studies.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Lijuan Bu, PhD, +86-18560088816, qlyykyc@163.ocm
About this study
The potential cardiovascular toxicity of tumor treatment and its resulting cardiovascular events have gradually become an important health risk for tumor survivors. Prevention and early identification of cardiovascular toxicity has now become one of the bottlenecks in improving the prognosis of cancer patients. Compared to conventional echocardiographic indicators, new ultrasound technology based on speckle tracking imaging (STI) has shown superiority in the diagnosis, risk stratification and prognosis evaluation of cardiovascular diseases. Crocin, one of the main active components of saffron, has been found protective effect on cardiovascular toxicity in basic studies. This is a randomized, double-blind, placebo-controlled, single-center clinical study to observe the effect of crocin on cardiovascular function caused by breast cancer treatment.
One hundred and twenty breast cancer patients planning to undergo radiotherapy or chemotherapy will be included and randomly divided into a crocin group and a placebo group to observe the effect of total saffron tablets on cardiovascular function in patients with early breast cancer radiotherapy and chemotherapy. Participants will take crocin or placebo (4 tablets/time, 3 times a day) during each cycle of chemotherapy for 8 days, started on the 1st day before radiotherapy/chemotherapy. Follow-up was performed every 3 months after enrollment, and the follow-up period was 6 months.
Primary study endpoints include the differences between groups in the difference in LVEF and GLS measured by echocardiography at the end of the experiment compared to baseline. Secondary study endpoint include the differences in the incidence rates of serum troponin exceeding the upper limit of normal value and NT-proBNP higher than the normal age reference value, the frequency and duration of chest tightness, chest pain and palpitation, the degree of arrhythmia and ST-T changes displayed by dynamic electrocardiogram, the other echocardiographic parameters (the E/e', global circumferential strain, global radial strain, 3D-GAS, LV torsion, LV rotation/derotation velocity, SDI, RVFWS, and indexes of left ventricular diastolic function and right ventricular function) at the end of the experiment compared to baseline between the two groups.
- Conditions
- Breast Cancer
- Being tested
- crocin, Placebo
- Keywords
- Breast cancer, Cancer therapy-related cardiac dysfunction, Crocin, Echocardiography, Speckle tracking technology
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
crocinDrug
Take saffron total glucosides tablets for 8 days during each chemotherapy (started on the 1st day before radiotherapy/chemotherapy), 4 tablets/time, 3 times a day.
PlaceboDrug
Take placebo piece during for 8 days during each chemotherapy (started on the 1st day before radiotherapy/chemotherapy), 4 tablets/time, 3 times a day
| Study group | Role | What they receive |
|---|---|---|
| Crocin group | Experimental | The chemotherapy/radiotherapy protocols are made by oncologists adopted for patients depending on specific conditions , take saffron total glucosides tablets(provided by Reyoung Pharmaceutical Co., Ltd.) for 8 days during each chemotherapy (started on the 1st day before chemotherapy), 4 tablets/time, 3 times a day. Receives: Drug: crocin |
| placebo group | Placebo comparator | Undergoing chemotherapy/radiotherapy protocols as planned, take placebo piece during(the same appearance of crocin tablets, production unit:Reyoung Pharmaceutical Co., Ltd.) for 8 days during each chemotherapy (started on the 1st day before chemotherapy), 4 tablets/time, 3 times a day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of LVEF measured by echocardiography
The differences between the two groups in the difference of LVEF measured by Echocardiography at the end of the experiment compared to that at the baseline.
Measured: At the end of 6-month follow-up compared to the baseline
The change of GLS measured by echocardiography
The differences between the two groups in the difference of GLS measured by Echocardiography at the end of the experiment compared to that at the baseline.
Measured: At the end of 6-month follow-up compared to the baseline
Secondary outcomes (10)
The incidences of the increase of serum troponin and/or NT-proBNP
Differences in the incidence rates of serum troponin exceeding the upper limit of normal value and NT-proBNP higher than the normal age reference value between the two groups during follow-up.
Measured: During 6 months of following up
The incidences of chest tightness, chest pain and palpitation
The differences in the incidence of chest tightness, chest pain and palpitation between the two groups
Measured: During 6 months of following up
The incidences of arrhythmia and ST-T changes
Differences between the two groups in the incidences of arrhythmia and ST-T changes displayed by dynamic electrocardiogram.
Measured: During 6 months of following up
The differences of global circumferential strain, global radial strain, global area strain measured by echocardiography.
Differences between groups in the difference in global circumferential strain, global radial strain, global area strain measured by echocardiography at the end of the experiment compared to baseline.
Measured: At the end of 6-month follow-up compared to the baseline
The indexes of E, e', a', tricuspid regurgitation velocity measured by echocardiography.
Differences between groups in the difference in the indexes of left ventricular diastolic function measured by echocardiography at the end of the experiment compared to baseline.
Measured: At the end of 6-month follow-up compared to the baseline
The indexe of E/e'measured by echocardiography.
Differences between groups in the difference in the indexes of left ventricular diastolic function measured by echocardiography at the end of the experiment compared to baseline.
Measured: At the end of 6-month follow-up compared to the baseline
The indexe of left atrial volume index (LAVI)measured by echocardiography.
Differences between groups in the difference in the indexes of left ventricular diastolic function measured by echocardiography at the end of the experiment compared to baseline.
Measured: At the end of 6-month follow-up compared to the baseline
The indexe of TAPSE measured by echocardiography.
Differences between groups in the difference in the right ventricular function monitoring indicators measured by echocardiography at the end of the experiment compared to baseline.
Measured: At the end of 6-month follow-up compared to the baseline
The indexe of RV fractional area change (FAC) measured by echocardiography.
Differences between groups in the difference in the right ventricular function monitoring indicators measured by echocardiography at the end of the experiment compared to baseline.
Measured: At the end of 6-month follow-up compared to the baseline
The indexe of right ventricular free wall global longitudinal strain (RVGLS) measured by echocardiography.
Differences between groups in the difference in the right ventricular function monitoring indicators measured by echocardiography at the end of the experiment compared to baseline.
Measured: At the end of 6-month follow-up compared to the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start29 Mar 2021
- Primary completion25 Jun 2023 (estimated)
- Study completion25 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Inclusion criteria: 1. Age 25-80 years old, female; 2. Patients diagnosed with breast cancer by histopathology; 3. Patients who plan to receive adjuvant radiotherapy/chemotherapy or combined adjuvant trastuzumab or pertuzumab targeted therapy; 4. Patients who completed at least 6 cycles of treatment after enrollment; Exclusion criteria: 1. pregnant or breastfeeding women; 2. Patients with poor echocardiographic image quality; 3. Persistent atrial fibrillation and severe arrhythmia affect the collection and analysis of ultrasound data; 4. Patients who are participating in other clinical studies. Eligible patients were randomly divided into 1:1 group and divided into crocin group and placebo control group. Both groups of subjects received crocin or placebo on the basis of standard anti-tumor treatment.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mei Zhang, PhD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504148
- Sponsor's protocol ID
- 6010121027
- Acronym
- ProtECtion
- Status last verified
- Jul 2022
- First submitted
- 4 Aug 2022
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share the study protocol,statistical Analysis Plan (SAP)and Informed Consent Form (ICF)of this research.
Publications
Zamorano JL, Lancellotti P, Rodriguez Munoz D, Aboyans V, Asteggiano R, Galderisi M, Habib G, Lenihan DJ, Lip GYH, Lyon AR, Lopez Fernandez T, Mohty D, Piepoli MF, Tamargo J, Torbicki A, Suter TM; ESC Scientific Document Group. 2016 ESC Position Paper on cancer treatments and cardiovascular toxicity developed under the auspices of the ESC Committee for Practice Guidelines: The Task Force for cancer treatments and cardiovascular toxicity of the European Society of Cardiology (ESC). Eur Heart J. 2016 Sep 21;37(36):2768-2801. doi: 10.1093/eurheartj/ehw211. Epub 2016 Aug 26. No abstract available.
PubMed 27567406Tarantini L, Gulizia MM, Di Lenarda A, Maurea N, Giuseppe Abrignani M, Bisceglia I, Bovelli D, De Gennaro L, Del Sindaco D, Macera F, Parrini I, Radini D, Russo G, Beatrice Scardovi A, Inno A. ANMCO/AIOM/AICO Consensus Document on clinical and management pathways of cardio-oncology: executive summary. Eur Heart J Suppl. 2017 May;19(Suppl D):D370-D379. doi: 10.1093/eurheartj/sux019. Epub 2017 May 2.
PubMed 28751851Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2015 update: a report from the American Heart Association. Circulation. 2015 Jan 27;131(4):e29-322. doi: 10.1161/CIR.0000000000000152. Epub 2014 Dec 17. No abstract available.
PubMed 25520374Arai M, Tomaru K, Takizawa T, Sekiguchi K, Yokoyama T, Suzuki T, Nagai R. Sarcoplasmic reticulum genes are selectively down-regulated in cardiomyopathy produced by doxorubicin in rabbits. J Mol Cell Cardiol. 1998 Feb;30(2):243-54. doi: 10.1006/jmcc.1997.0588.
PubMed 9515001Papadopoulou LC, Theophilidis G, Thomopoulos GN, Tsiftsoglou AS. Structural and functional impairment of mitochondria in adriamycin-induced cardiomyopathy in mice: suppression of cytochrome c oxidase II gene expression. Biochem Pharmacol. 1999 Mar 1;57(5):481-9. doi: 10.1016/s0006-2952(98)00305-0.
PubMed 9952311Chen XL, Lei YH, Liu CF, Yang QF, Zuo PY, Liu CY, Chen CZ, Liu YW. Angiogenesis inhibitor bevacizumab increases the risk of ischemic heart disease associated with chemotherapy: a meta-analysis. PLoS One. 2013 Jun 20;8(6):e66721. doi: 10.1371/journal.pone.0066721. Print 2013.
PubMed 23818962Schutz FAB, Je Y, Azzi GR, Nguyen PL, Choueiri TK. Bevacizumab increases the risk of arterial ischemia: a large study in cancer patients with a focus on different subgroup outcomes. Ann Oncol. 2011 Jun;22(6):1404-1412. doi: 10.1093/annonc/mdq587. Epub 2010 Nov 29.
PubMed 21115602Ranpura V, Hapani S, Chuang J, Wu S. Risk of cardiac ischemia and arterial thromboembolic events with the angiogenesis inhibitor bevacizumab in cancer patients: a meta-analysis of randomized controlled trials. Acta Oncol. 2010 Apr;49(3):287-97. doi: 10.3109/02841860903524396.
PubMed 20156114Suter TM, Ewer MS. Cancer drugs and the heart: importance and management. Eur Heart J. 2013 Apr;34(15):1102-11. doi: 10.1093/eurheartj/ehs181. Epub 2012 Jul 12.
PubMed 22789916Carver JR, Shapiro CL, Ng A, Jacobs L, Schwartz C, Virgo KS, Hagerty KL, Somerfield MR, Vaughn DJ; ASCO Cancer Survivorship Expert Panel. American Society of Clinical Oncology clinical evidence review on the ongoing care of adult cancer survivors: cardiac and pulmonary late effects. J Clin Oncol. 2007 Sep 1;25(25):3991-4008. doi: 10.1200/JCO.2007.10.9777. Epub 2007 Jun 18.
PubMed 17577017Malanca M, Cimadevilla C, Brochet E, Iung B, Vahanian A, Messika-Zeitoun D. Radiotherapy-induced mitral stenosis: a three-dimensional perspective. J Am Soc Echocardiogr. 2010 Jan;23(1):108.e1-2. doi: 10.1016/j.echo.2009.08.006. Epub 2009 Sep 18.
PubMed 19766451Darby SC, Cutter DJ, Boerma M, Constine LS, Fajardo LF, Kodama K, Mabuchi K, Marks LB, Mettler FA, Pierce LJ, Trott KR, Yeh ET, Shore RE. Radiation-related heart disease: current knowledge and future prospects. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3):656-65. doi: 10.1016/j.ijrobp.2009.09.064.
PubMed 20159360Plana JC, Galderisi M, Barac A, Ewer MS, Ky B, Scherrer-Crosbie M, Ganame J, Sebag IA, Agler DA, Badano LP, Banchs J, Cardinale D, Carver J, Cerqueira M, DeCara JM, Edvardsen T, Flamm SD, Force T, Griffin BP, Jerusalem G, Liu JE, Magalhaes A, Marwick T, Sanchez LY, Sicari R, Villarraga HR, Lancellotti P. Expert consensus for multimodality imaging evaluation of adult patients during and after cancer therapy: a report from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging. 2014 Oct;15(10):1063-93. doi: 10.1093/ehjci/jeu192. No abstract available.
PubMed 25239940Amundsen BH, Helle-Valle T, Edvardsen T, Torp H, Crosby J, Lyseggen E, Stoylen A, Ihlen H, Lima JA, Smiseth OA, Slordahl SA. Noninvasive myocardial strain measurement by speckle tracking echocardiography: validation against sonomicrometry and tagged magnetic resonance imaging. J Am Coll Cardiol. 2006 Feb 21;47(4):789-93. doi: 10.1016/j.jacc.2005.10.040. Epub 2006 Jan 26.
PubMed 16487846Huang SJ, Orde S. From speckle tracking echocardiography to torsion: research tool today, clinical practice tomorrow. Curr Opin Crit Care. 2013 Jun;19(3):250-7. doi: 10.1097/MCC.0b013e32836092b7.
PubMed 23519081
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protection of Cardiovascular Function With Crocin in BrEast Cancer Patients Undergoing Radiotherapy and Chemotherapy
- ClinicalTrials.gov ID
- NCT05504148
- Acronym / sponsor ID
- ProtECtion / 6010121027
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Cancer therapy-related cardiac dysfunction, Crocin, Echocardiography, Speckle tracking technology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 25 Jun 2023 (estimated)
- Study completion
- 25 Sep 2023 (estimated)
- First posted
- 17 Aug 2022 (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.
The potential cardiovascular toxicity of tumor treatment and its resulting cardiovascular events have gradually become an important health risk for tumor survivors. Prevention and early identification of cardiovascular toxicity has now become one of the bottlenecks in improving the prognosis of cancer patients. Compared to conventional echocardiographic indicators, new ultrasound technology based on speckle tracking imaging (STI) has shown superiority in the diagnosis, risk stratification and prognosis evaluation of cardiovascular diseases. Crocin, one of the main active components of saffron, has been found protective effect on cardiovascular toxicity in basic studies. This is a randomized, double-blind, placebo-controlled, single-center clinical study to observe the effect of crocin on cardiovascular function caused by breast cancer treatment.
One hundred and twenty breast cancer patients planning to undergo radiotherapy or chemotherapy will be included and randomly divided into a crocin group and a placebo group to observe the effect of total saffron tablets on cardiovascular function in patients with early breast cancer radiotherapy and chemotherapy. Participants will take crocin or placebo (4 tablets/time, 3 times a day) during each cycle of chemotherapy for 8 days, started on the 1st day before radiotherapy/chemotherapy. Follow-up was performed every 3 months after enrollment, and the follow-up period was 6 months.
Primary study endpoints include the differences between groups in the difference in LVEF and GLS measured by echocardiography at the end of the experiment compared to baseline. Secondary study endpoint include the differences in the incidence rates of serum troponin exceeding the upper limit of normal value and NT-proBNP higher than the normal age reference value, the frequency and duration of chest tightness, chest pain and palpitation, the degree of arrhythmia and ST-T changes displayed by dynamic electrocardiogram, the other echocardiographic parameters (the E/e', global circumferential strain, global radial strain, 3D-GAS, LV torsion, LV rotation/derotation velocity, SDI, RVFWS, and indexes of left ventricular diastolic function and right ventricular function) at the end of the experiment compared to baseline between the two groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Inclusion criteria: 1. Age 25-80 years old, female; 2. Patients diagnosed with breast cancer by histopathology; 3. Patients who plan to receive adjuvant radiotherapy/chemotherapy or combined adjuvant trastuzumab or pertuzumab targeted therapy; 4. Patients who completed at least 6 cycles of treatment after enrollment; Exclusion criteria: 1. pregnant or breastfeeding women; 2. Patients with poor echocardiographic image quality; 3. Persistent atrial fibrillation and severe arrhythmia affect the collection and analysis of ultrasound data; 4. Patients who are participating in other clinical studies. Eligible patients were randomly divided into 1:1 group and divided into crocin group and placebo control group. Both groups of subjects received crocin or placebo on the basis of standard anti-tumor treatment.
| Arm | Type | Receives |
|---|---|---|
| Crocin group | Experimental | Drug: crocinThe chemotherapy/radiotherapy protocols are made by oncologists adopted for patients depending on specific conditions , take saffron total glucosides tablets(provided by Reyoung Pharmaceutical Co., Ltd.) for 8 days during each chemotherapy (started on the 1st day before chemotherapy), 4 tablets/time, 3 times a day. |
| placebo group | Placebo comparator | Drug: PlaceboUndergoing chemotherapy/radiotherapy protocols as planned, take placebo piece during(the same appearance of crocin tablets, production unit:Reyoung Pharmaceutical Co., Ltd.) for 8 days during each chemotherapy (started on the 1st day before chemotherapy), 4 tablets/time, 3 times a day |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 25-80 years old, female;
- Patients diagnosed with breast cancer by histopathology;
- Patients who plan to receive adjuvant radiotherapy/chemotherapy or combined adjuvant trastuzumab or pertuzumab targeted therapy;
- Patients who completed at least 6 cycles of treatment after enrollment;
Key exclusion criteria (4 listed)
- pregnant or breastfeeding women;
- Patients with poor echocardiographic image quality;
- Persistent atrial fibrillation and severe arrhythmia affect the collection and analysis of ultrasound data;
- Patients who are participating in other clinical studies.
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 |
|---|---|---|
| crocinTake saffron total glucosides tablets for 8 days during each chemotherapy (started on the 1st day before radiotherapy/chemotherapy), 4 tablets/time, 3 times a day. | Drug | Crocin group |
| PlaceboTake placebo piece during for 8 days during each chemotherapy (started on the 1st day before radiotherapy/chemotherapy), 4 tablets/time, 3 times a day | Drug | placebo group |
Primary outcome
The change of LVEF measured by echocardiography
Time frame: At the end of 6-month follow-up compared to the baseline
The differences between the two groups in the difference of LVEF measured by Echocardiography at the end of the experiment compared to that at the baseline.
The change of GLS measured by echocardiography
Time frame: At the end of 6-month follow-up compared to the baseline
The differences between the two groups in the difference of GLS measured by Echocardiography at the end of the experiment compared to that at the baseline.
10 secondary outcomes
The incidences of the increase of serum troponin and/or NT-proBNP
Time frame: During 6 months of following up
The incidences of chest tightness, chest pain and palpitation
Time frame: During 6 months of following up
The incidences of arrhythmia and ST-T changes
Time frame: During 6 months of following up
The differences of global circumferential strain, global radial strain, global area strain measured by echocardiography.
Time frame: At the end of 6-month follow-up compared to the baseline
The indexes of E, e', a', tricuspid regurgitation velocity measured by echocardiography.
Time frame: At the end of 6-month follow-up compared to the baseline
The indexe of E/e'measured by echocardiography.
Time frame: At the end of 6-month follow-up compared to the baseline
The indexe of left atrial volume index (LAVI)measured by echocardiography.
Time frame: At the end of 6-month follow-up compared to the baseline
The indexe of TAPSE measured by echocardiography.
Time frame: At the end of 6-month follow-up compared to the baseline
The indexe of RV fractional area change (FAC) measured by echocardiography.
Time frame: At the end of 6-month follow-up compared to the baseline
The indexe of right ventricular free wall global longitudinal strain (RVGLS) measured by echocardiography.
Time frame: At the end of 6-month follow-up compared to the baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Background: PubMed 27567406Zamorano JL, Lancellotti P, Rodriguez Munoz D, Aboyans V, Asteggiano R, Galderisi M, Habib G, Lenihan DJ, Lip GYH, Lyon AR, Lopez Fernandez T, Mohty D, Piepoli MF, Tamargo J, Torbicki A, Suter TM; ESC Scientific Document Group. 2016 ESC Position Paper on cancer treatments and cardiovascular toxicity developed under the auspices of the ESC Committee for Practice Guidelines: The Task Force for cancer treatments and cardiovascular toxicity of the European Society of Cardiology (ESC). Eur Heart J. 2016 Sep 21;37(36):2768-2801. doi: 10.1093/eurheartj/ehw211. Epub 2016 Aug 26. No abstract available.
- Background: PubMed 28751851Tarantini L, Gulizia MM, Di Lenarda A, Maurea N, Giuseppe Abrignani M, Bisceglia I, Bovelli D, De Gennaro L, Del Sindaco D, Macera F, Parrini I, Radini D, Russo G, Beatrice Scardovi A, Inno A. ANMCO/AIOM/AICO Consensus Document on clinical and management pathways of cardio-oncology: executive summary. Eur Heart J Suppl. 2017 May;19(Suppl D):D370-D379. doi: 10.1093/eurheartj/sux019. Epub 2017 May 2.
- Background: PubMed 25520374Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2015 update: a report from the American Heart Association. Circulation. 2015 Jan 27;131(4):e29-322. doi: 10.1161/CIR.0000000000000152. Epub 2014 Dec 17. No abstract available.
- Background: PubMed 9515001Arai M, Tomaru K, Takizawa T, Sekiguchi K, Yokoyama T, Suzuki T, Nagai R. Sarcoplasmic reticulum genes are selectively down-regulated in cardiomyopathy produced by doxorubicin in rabbits. J Mol Cell Cardiol. 1998 Feb;30(2):243-54. doi: 10.1006/jmcc.1997.0588.
- Background: PubMed 9952311Papadopoulou LC, Theophilidis G, Thomopoulos GN, Tsiftsoglou AS. Structural and functional impairment of mitochondria in adriamycin-induced cardiomyopathy in mice: suppression of cytochrome c oxidase II gene expression. Biochem Pharmacol. 1999 Mar 1;57(5):481-9. doi: 10.1016/s0006-2952(98)00305-0.
- Background: PubMed 23818962Chen XL, Lei YH, Liu CF, Yang QF, Zuo PY, Liu CY, Chen CZ, Liu YW. Angiogenesis inhibitor bevacizumab increases the risk of ischemic heart disease associated with chemotherapy: a meta-analysis. PLoS One. 2013 Jun 20;8(6):e66721. doi: 10.1371/journal.pone.0066721. Print 2013.
- Background: PubMed 21115602Schutz FAB, Je Y, Azzi GR, Nguyen PL, Choueiri TK. Bevacizumab increases the risk of arterial ischemia: a large study in cancer patients with a focus on different subgroup outcomes. Ann Oncol. 2011 Jun;22(6):1404-1412. doi: 10.1093/annonc/mdq587. Epub 2010 Nov 29.
- Background: PubMed 20156114Ranpura V, Hapani S, Chuang J, Wu S. Risk of cardiac ischemia and arterial thromboembolic events with the angiogenesis inhibitor bevacizumab in cancer patients: a meta-analysis of randomized controlled trials. Acta Oncol. 2010 Apr;49(3):287-97. doi: 10.3109/02841860903524396.
- Background: PubMed 22789916Suter TM, Ewer MS. Cancer drugs and the heart: importance and management. Eur Heart J. 2013 Apr;34(15):1102-11. doi: 10.1093/eurheartj/ehs181. Epub 2012 Jul 12.
- Background: PubMed 17577017Carver JR, Shapiro CL, Ng A, Jacobs L, Schwartz C, Virgo KS, Hagerty KL, Somerfield MR, Vaughn DJ; ASCO Cancer Survivorship Expert Panel. American Society of Clinical Oncology clinical evidence review on the ongoing care of adult cancer survivors: cardiac and pulmonary late effects. J Clin Oncol. 2007 Sep 1;25(25):3991-4008. doi: 10.1200/JCO.2007.10.9777. Epub 2007 Jun 18.
- Background: PubMed 19766451Malanca M, Cimadevilla C, Brochet E, Iung B, Vahanian A, Messika-Zeitoun D. Radiotherapy-induced mitral stenosis: a three-dimensional perspective. J Am Soc Echocardiogr. 2010 Jan;23(1):108.e1-2. doi: 10.1016/j.echo.2009.08.006. Epub 2009 Sep 18.
- Background: PubMed 20159360Darby SC, Cutter DJ, Boerma M, Constine LS, Fajardo LF, Kodama K, Mabuchi K, Marks LB, Mettler FA, Pierce LJ, Trott KR, Yeh ET, Shore RE. Radiation-related heart disease: current knowledge and future prospects. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3):656-65. doi: 10.1016/j.ijrobp.2009.09.064.
- Individual participant dataSharing planned: Yes. We plan to share the study protocol,statistical Analysis Plan (SAP)and Informed Consent Form (ICF)of this research.
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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.
Mei Zhang, PhD principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing crocin in people with Breast Cancer, run by Qilu Hospital of Shandong University 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 4 inclusion and 4 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 22 Sep 2022. 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. 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?
Contact Mei Zhang, PhD (+86-18560086629, daixh@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of LVEF measured by echocardiography (time frame: At the end of 6-month follow-up compared to the baseline). 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 NCT05504148, which also lists 18 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 22 Sep 2022.