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All Conditions

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Carcinoma

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Endocrine Gland Neoplasms

Ovarian Diseases

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Genital Diseases, Female

Genital Diseases

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Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

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Tocotrienols

alpha-Tocopherol

Antineoplastic Agents, Immunological

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Antioxidants

Protective Agents

Trace Elements

Tocopherol

Tocotrienol

Capsules, 300 mg orally three times daily

Torben F Hansen, MD, DMSc

A recent study at the Department of Oncology, Vejle Hospital (NCT02399592), investigated bevacizumab and tocotrienol in ovarian cancer patients and concurrently monitored the level of methylated HOXA9 circulating tumor DNA (HOXA9 meth-ctDNA) in the blood.

The rate of disease control was 70% with better results than other studies using bevacizumab alone. The toxicity was very low and attributed to bevacizumab only.

When the study results were worked up they showed that patients with a significant increase of HOXA9 meth-ctDNA after the first cycle of treatment did not benefit from the treatment whereas those with stable or decreasing HOXA9 meth-ctDNA did.

Therefore, in the current study patients with a high increase of HOXA9 meth-ctDNA after the first treatment cycle will discontinue treatment, as it is then considered ineffective. The remaining patients may achieve prolonged survival as predicted by their level of HOXA9 meth-ctDNA.

Bevacizumab and Tocotrienol in Recurrent Ovarian Cancer

Bevacizumab and Tocotrienol in Recurrent Ovarian Cancer: A Marker Based Phase II Trial

CTC = National Cancer Institute's Common Toxicity Criteria (NCI-CTC)

Vejle Hospital

Digestive System Diseases

Colorectal Neoplasms

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Digestive System Neoplasms

Gastrointestinal Diseases

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Rectal Diseases

Bone Density Conservation Agents

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Capecitabine

Leucovorin

Fluorouracil

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Oxaliplatin

Calcium

Calcium, Dietary

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antidotes

Folic Acid

Vitamin B Complex

Folinic Acid

Folate

Vitamin B9

Fluorouracil + calcium folinate + oxaliplatin + bevacizumab + tocotrienol OR capecitabine + bevacizumab + tocotrienol

Fluorouracil + calcium folinate + oxaliplatin + bevacizumab + placebo OR capecitabine + bevacizumab + placebo

Calcium folinate

Placebo

Natacha Trabjerg, MD

Torben F Hansen, MD, PhD

This double blind, randomized phase II trial will investigate whether the addition of tocotrienol will improve the effect and lower the toxicity of standard chemotherapy and bevacizumab. Half of the patients will receive tocotrienol and the other half placebo. Treatment is planned for a period of maximum six months and will be discontinued earlier in case of progression or unacceptable toxicity.

Tocotrienol and Bevacizumab in Metastatic Colorectal Cancer

Tocotrienol and Bevacizumab in Metastatic Colorectal Cancer. A Randomized Phase II Marker Trial

CTCAE=Common Terminology Criteria for Adverse Events

RECIST=Response evaluation criteria in solid tumors

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Subjects receiveTocotrienol 200 mg/twice daily before surgery

Cristina Ferraris, MD

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.

An open-label, single center, phase 2 prospective observational clinical study

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

Preoperative Use of Tocotrienol Associated With Personalized Nutritional and Psychoeducational Support in Women With Primary Breast Cancer.

Oxidant capacity (through tock fast-Li Starfish) (µmol/L) was measured in patients' serum samples.

Antioxidant capacity (through TAC Track, Li Starfish) (µmol/L) was measured in patients' serum samples.

Peripheral blood mononuclear cells were measured by 13-color cytofluorimetry analysis in patients' serum samples.

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

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

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

Treatment-induced changes in proliferation/apoptosis, anti-inflammatory and anti-oxidant activity of breast cancer cell lines was measured through cell culture analysis.

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

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Bevacizumab and Tocotrienol in Recurrent Ovarian Cancer	NCT04175470	Ovarian Cancer ...	Bevacizumab Tocotrienol	18 Years -	Vejle Hospital
Tocotrienol and Bevacizumab in Metastatic Colorectal Cancer	NCT04245865	Colorectal Canc...	Fluorouracil Calcium folinat... Oxaliplatin Bevacizumab Capecitabine Tocotrienol Placebo	18 Years -	Vejle Hospital
Preoperative Use of Tocotrienol From Annatto Bixa Orellana L. in Breast Cancer Patients: a Prospective Clinical Trial.	NCT04496492	Breast Cancer	Tocotrienol	30 Years - 65 Years	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Preoperative Use of Tocotrienol From Annatto Bixa Orellana L. in Breast Cancer Patients: a Prospective Clinical Trial.	NCT04496492	Breast Cancer	Tocotrienol	30 Years - 65 Years	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Bevacizumab and Tocotrienol in Recurrent Ovarian Cancer	NCT04175470	Ovarian Cancer ...	Bevacizumab Tocotrienol	18 Years -	Vejle Hospital
Bevacizumab and Tocotrienol in Recurrent Ovarian Cancer	NCT04175470	Ovarian Cancer ...	Bevacizumab Tocotrienol	18 Years -	Vejle Hospital

Spots Global Cancer Trial Database for tocotrienol

Every month we try and update this database with for tocotrienol cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tocotrienol

Every month we try and update this database with for tocotrienol cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tocotrienol cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.