75 patients, treatment with Curcumin (CUC-01, yellow solution), 300mg i.v. plus i.v. Paclitaxel (colorless solution) 80 mg /m2 BS i.e., once weekly for 12 weeks.

Group B, 75 patients, treatment with Paclitaxel (colorless solution) 80 mg /m2 BS, i.v. plus placebo i.v. solution (250 ml, yellow solution for masking/blinding), once weekly for 12 weeks.

Advanced Breast Cancer

Metastatic Breast Cancer

Curcumin (CUC-01), 300mg i.v. , once weekly for 12 weeks.

Curcumin

Paclitaxel (colorless solution) 80 mg /m2 BS, i.v., once weekly for 12 weeks.

Paclitaxel

Placebo i.v. solution, once weekly for 12 weeks

Placebo

National Center of Oncology

"Curcumin" in Combination With Chemotherapy in Advanced Breast Cancer

Study of Efficacy of Curcumin in Combination With Chemotherapy in Patients With Advanced Breast Cancer: Randomized, Double Blind, Placebo Controlled Clinical Trial

Objective response rate, assessed with the Modified Response Evaluation Criteria In Solid Tumours (RECIST).

Adverse events and defined by National Cancer Institute (NCI) Common Toxicity Criteria Version 4.0 (CTCAE, v4.0≤).

Health status measured by Global Health Status/QoL scale of EORTC QLQ-C30.

Progression free survival assessed from study enrolment to tumour progression as per the Modified RECIST criteria.

Time to Treatment Failure assessed from study enrolment to cessation of study treatment for any reason.

Time to Tumour Progression assessed from study enrolment to tumour progression as per the Modified RECIST criteria.

National Center of Oncology, Armenia

BRIU GmbH

Placebo
Placebo: daily placebo for 6 weeks

Total

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

The primary outcome to be measured will be the change in NF-kB DNA binding (measured in peripheral blood mononuclear cells as ng/well) after six weeks of treatment with daily placebo or Meriva. NF-kB DNA binding and has been associated with fatigue in breast cancer patients.

PBMC NF-kB DNA Binding Measured in ng/Well

The secondary outcome to be measured will be the change in plasma TNF-alpha after six weeks of treatment with daily placebo or Meriva. Plasma TNF-alpha is a downstream mediator of NF-kB DNA binding and has been associated with fatigue in breast cancer patients.

Plasma TNF-alpha

The secondary outcome to be measured will be the change in plasma sTNFR2 (in pg/ml) after six weeks of treatment with daily placebo or Meriva. Plasma sTNFR2 is a downstream mediator of NF-kB DNA binding and has been associated with fatigue in breast cancer patients.

Plasma sTNFR2 Measured in pg/ml

The secondary outcome to be measured will be the change in plasma IL-1ra (in pg/ml) after six weeks of treatment with daily placebo or Meriva. Plasma IL-1ra is a downstream mediator of NF-kB DNA binding and has been associated with fatigue in breast cancer patients.

Plasma IL-1ra Measured in pg/ml

The primary outcome to be measured will be the change in plasma IL-6 after six weeks of treatment with daily placebo or Meriva.

Plasma IL-6 Measured in pg/ml

The primary outcome to be measured will be the change in plasma CRP after six weeks of treatment with daily placebo or Meriva.

Plasma C-reactive Protein (CRP) Measured in mg/L

The secondary outcome to be measured will be the change in fatigue (as measured by the Multidimensional Fatigue Inventory [MFI] total score) after six weeks of treatment with daily placebo or Meriva. The MFI is a 20-item scale designed to evaluate fatigue. Respondents use a scale ranging from 1 to 5 for each item to indicate how statements regarding fatigue represent their experiences. The range of scores is from a minimum of 20 and a maximum of 100. Higher total scores correspond with more acute levels of fatigue.

curcuminoid/рак на гърдата

"Curcumin" in Combination With Chemotherapy in Advanced Breast Cancer

Phase II Study of Curcumin vs Placebo for Chemotherapy-Treated Breast Cancer Patients Undergoing Radiotherapy

Най-пълната база данни за лечебни билки, подкрепена от науката