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Trial record 5 of 712 for:    tocotrienols

Preoperative Use of Tocotrienol From Annatto Bixa Orellana L. in Breast Cancer Patients: a Prospective Clinical Trial. (TOCANNATO)

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ClinicalTrials.gov Identifier: NCT04496492
Recruitment Status : Completed
First Posted : August 3, 2020
Last Update Posted : August 3, 2020
Sponsor:
Information provided by (Responsible Party):
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Tracking Information
First Submitted Date  ICMJE June 26, 2020
First Posted Date  ICMJE August 3, 2020
Last Update Posted Date August 3, 2020
Actual Study Start Date  ICMJE February 9, 2016
Actual Primary Completion Date February 9, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2020)
  • Changes in blood oxidant capacity [ Time Frame: 4 weeks ]
    Oxidant capacity (through tock fast-Li Starfish) (µmol/L) was measured in patients' serum samples.
  • Changes in blood antioxidant capacity [ Time Frame: 4 weeks ]
    Antioxidant capacity (through TAC Track, Li Starfish) (µmol/L) was measured in patients' serum samples.
  • Absolute and relative changes in peripheral blood mononuclear cells obtained before and after four weeks of tocotrienol treatment, as detected by 13-colors citofluorimetry analysis [ Time Frame: 4 weeks ]
    Peripheral blood mononuclear cells were measured by 13-color cytofluorimetry analysis in patients' serum samples.
  • Changes of immune-related miRNA levels in patients' serum samples obtained before and after four weeks of tocotrienol treatment, as determined by quantitative real-time PCR analysis [ Time Frame: 4 weeks ]
    Immune-related miRNA levels were determined by quantitative real-time PCR analysis in patients' serum samples obtained before and after four weeks of tocotrienol treatment
  • Changes in immune response associated gene levels in preoperative tissue tumor biopsies and in surgical specimens, obtained before and after four weeks of tocotrienol treatment, respectively, as determined by gene expression profiling analysis [ Time Frame: 4 weeks ]
    Immune response associated gene levels were determined by gene expression profiling analysis in preoperative tissue tumor biopsies and in surgical specimens, obtained before and after four weeks of tocotrienol treatment
  • Changes in serum inflammatory cytokines and growth factor [ Time Frame: 4 weeks ]
    Blood inflammatory cytokines and growth factor (through TNF-alpha (pg/ml), IL-6 (pg/ml) and VEGF (pg/ml) quantifications) were measured in patients' serum samples
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2020)
  • Treatment-induced changes in proliferation/apoptosis, anti-inflammatory and anti-oxidant activity of breast cancer cell lines [ Time Frame: 12,24 and 72 hours ]
    Treatment-induced changes in proliferation/apoptosis, anti-inflammatory and anti-oxidant activity of breast cancer cell lines was measured through cell culture analysis.
  • Changes in expression of tumor proliferation, hormone receptors and HER2 [ Time Frame: 4 weeks ]
    Expression of tumor proliferation index (Ki67), estrogen and/progesterone receptor and HER2 oncoprotein by IHC was determined in preoperative tumor biopsies and in surgical specimens
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preoperative Use of Tocotrienol From Annatto Bixa Orellana L. in Breast Cancer Patients: a Prospective Clinical Trial.
Official Title  ICMJE Preoperative Use of Tocotrienol Associated With Personalized Nutritional and Psychoeducational Support in Women With Primary Breast Cancer.
Brief Summary

Tocotrienols have shown strong in vitro and in vivo anti-oxidant and anticancer activity, promoting apoptosis and regulating oncogenic targets in breast cancer. However their clinical use is still experimental especially in preoperative setting, where there are still no data of antioxidant and antiinflammatory beneficial roles. This study is a prospective observational clinical study enrolling 50 patients with primary breast cancer (T1-2, N0-1, M0) who received 4-weeks oral treatment of delta-T3 before surgery (200 mg/twice daily) with personalized nutritional and psychoeducational support. This study evaluates the effects of treatment on oxidant (tock fast-Li Starfish) and antioxidant capacity (TAC Track, Li Starfish), anti-inflammatory activity (complete profiling of adaptive and innate cell immunity, immunologic serum markers (miRNA)), immunological response on tumor (gene expression profiling on preoperative tissue tumor biopsy and on surgical specimen), TNF-alpha, IL-6 and VEGF and proliferation/apoptosis, anti-inflammatory and anti-oxidant activity of breast cancer cell lines.

This study evaluates the effects of treatment on oxidant (tock fast-Li Starfish) and antioxidant capacity (TAC Track, Li Starfish), on anti-inflammatory activity (complete profiling of adaptive and innate cell immunity, immunologic serum markers (miRNA)), on immunological response on tumor (gene expression profiling on preoperative tissue tumor biopsy and on surgical specimen), on TNF-alpha, IL-6 and VEGF, on proliferation/apoptosis, anti-inflammatory and anti-oxidant activity of breast cancer cell lines.

Detailed Description An open-label, single center, phase 2 prospective observational clinical study
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Drug: Tocotrienol
Tocotrienol 200 mg orally twice a day
Study Arms  ICMJE Experimental: Tocotrienol
Subjects receiveTocotrienol 200 mg/twice daily before surgery
Intervention: Drug: Tocotrienol
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 29, 2020)
50
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 6, 2017
Actual Primary Completion Date February 9, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • histologically confirmed operable primary breast cancer (T1-T2 N0-1 M0)
  • absence of distant metastasis
  • signed informed consent.

Exclusion Criteria:

  • Previous malignancies other than in situ cervical carcinoma or nonmelanoma skin cancer
  • Breast cancer recurrence
  • Metastatic breast cancer
  • Non-epithelial breast cancer at histological examination
  • In situ lobular breast cancer
  • Participation in other randomized clinical trials that could interfere with current study
  • Living distant from center and unable to attend for check-ups and meetings
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04496492
Other Study ID Numbers  ICMJE 2014-005275-92
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study Sponsor  ICMJE Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cristina Ferraris, MD Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
PRS Account Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP