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

NCT01740323 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: IRB00055328Winship2139-11R21CA178603
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of the investigation is to determine if curcumin reduces NF-kB DNA binding and ultimately its downstream mediator IL-6 in patients receiving XRT for their breast cancer after having completed chemotherapy. Patients who have received prior chemotherapy will be eligible, because we have found that this enriched population is at particular risk for exhibiting increased NF-kB DNA binding and IL-6 following XRT.

Conditions

Breast Cancer

Keywords

Breast Cancer; Chemotherapy; Radiotherapy; NF-kB; DNA Binding; Curcumin; IL-6; TNF; sTNFR2; IL-1-ra; Fatigue; Cytokine

Outcome Measures

Primary Outcomes (6)

• PBMC NF-kB DNA Binding Measured in ng/Well

  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.

  Baseline, 6 weeks following completion of XRT

• Plasma TNF-alpha

  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.

  Baseline, 6 weeks following completion of XRT

• Plasma sTNFR2 Measured in pg/ml

  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.

  Baseline, 6 weeks following completion of XRT

• Plasma IL-1ra 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.

  Baseline, 6 weeks following completion of XRT

• Plasma IL-6 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.

  Baseline, 6 weeks following completion of XRT

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

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

  Baseline, 6 weeks following completion of XRT

Secondary Outcomes (1)

• Fatigue

  Baseline, 6 weeks following completion of XRT

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Curcumin

EXPERIMENTAL

500 mg BID

Drug: Curcumin

Interventions

Placebo DRUG

daily placebo for 6 weeks

Placebo

Curcumin DRUG

500 mg BID

Also known as: Meriva

Curcumin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female breast cancer patients over the age of 18 will be recruited for this study. Patients enrolled in the study will meet standard criteria for whole breast XRT.

You may not qualify if:

• Subjects will be excluded for a number of medical conditions that are contraindications to XRT and/or might confound the relationship among fatigue, and inflammation, including pregnancy, major psychiatric disorders, autoimmune or inflammatory disorders, chronic infectious diseases (e.g. HIV, hepatitis B or C), neurologic disorders and uncontrolled cardiovascular, metabolic, pulmonary or renal disease (as determined by medical history, physical examination and laboratory testing). Subjects with a history of a major psychiatric disorder including Schizophrenia or Bipolar Disorder or a diagnosis of Substance Abuse or Dependence within the past 1 year (as determined by standardized psychiatric interview) will be excluded. Subjects taking drugs known to affect the immune system (e.g. glucocorticoids, methotrexate) will also be excluded. Subjects using supplements or other natural products with one week of starting medications, excluding vitamins and calcium supplementation or at the discretion of the attending physician, will be excluded. Patients who have evidence of infection as determined by history, physical exam or laboratory testing (complete blood count and urinalysis) at baseline will be excluded. In addition, patients who develop evidence of infection (as determined by history, physical exam or laboratory testing) during the study will be discontinued from the study.

Sponsors & Collaborators

• Andrew H Miller: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Fatigue

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Results Point of Contact

• Title: Andrew Miller, MD
• Organization: Emory University

amill02@emory.edu

404-727-8260

Study Officials

• Andrew H Miller, MD

  Emory Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor Investigator

Study Record Dates

• First Submitted: November 30, 2012
• First Posted: December 4, 2012
• Study Start: May 1, 2015
• Primary Completion: July 27, 2018
• Study Completion: July 27, 2018
• Last Updated: September 18, 2019
• Results First Posted: September 18, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)