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Trial record 16 of 80 for:    "curcumin" and "cancer"

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

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ClinicalTrials.gov Identifier: NCT01740323
Recruitment Status : Completed
First Posted : December 4, 2012
Results First Posted : September 18, 2019
Last Update Posted : September 18, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Andrew H Miller, Emory University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: Placebo
Drug: Curcumin
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Curcumin
Hide Arm/Group Description

Placebo

Placebo: daily placebo for 6 weeks

500 mg BID

Curcumin: 500 mg BID

Period Title: Overall Study
Started 15 15
Completed 13 15
Not Completed 2 0
Reason Not Completed
Adverse Event             1             0
Randomized but did not take study drug             1             0
Arm/Group Title Placebo Curcumin Total
Hide Arm/Group Description

Placebo

Placebo: daily placebo for 6 weeks

500 mg BID

Curcumin: 500 mg BID

Total of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
51.87  (10.67) 50.47  (10.01) 51.17  (10.19)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
15
 100.0%
15
 100.0%
30
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
15
 100.0%
15
 100.0%
30
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   6.7%
1
   6.7%
2
   6.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
  46.7%
6
  40.0%
13
  43.3%
White
7
  46.7%
7
  46.7%
14
  46.7%
More than one race
0
   0.0%
1
   6.7%
1
   3.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title PBMC NF-kB DNA Binding Measured in ng/Well
Hide Description 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.
Time Frame Baseline, 6 weeks following completion of XRT
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Curcumin
Hide Arm/Group Description:

Placebo

Placebo: daily placebo for 6 weeks

500 mg BID

Curcumin: 500 mg BID

Overall Number of Participants Analyzed 13 15
Mean (Standard Deviation)
Unit of Measure: ng/well
Baseline 9.01  (14.70) 9.56  (5.63)
6 weeks post-treatment 17.54  (9.24) 16.04  (16.13)
2.Primary Outcome
Title Plasma TNF-alpha
Hide Description 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.
Time Frame Baseline, 6 weeks following completion of XRT
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Curcumin
Hide Arm/Group Description:

Placebo

Placebo: daily placebo for 6 weeks

500 mg BID

Curcumin: 500 mg BID

Overall Number of Participants Analyzed 13 15
Mean (Standard Deviation)
Unit of Measure: ng/well
Baseline 5.87  (3.52) 4.93  (1.75)
6 weeks post-treatment 4.93  (1.75) 5.24  (0.97)
3.Primary Outcome
Title Plasma sTNFR2 Measured in pg/ml
Hide Description 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.
Time Frame Baseline, 6 weeks following completion of XRT
Hide Outcome Measure Data
Hide Analysis Population Description
Assays were not analyzed due to lack of funding.
Arm/Group Title Placebo Curcumin
Hide Arm/Group Description:

Placebo

Placebo: daily placebo for 6 weeks

500 mg BID

Curcumin: 500 mg BID

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Primary Outcome
Title Plasma IL-1ra Measured in pg/ml
Hide Description 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.
Time Frame Baseline, 6 weeks following completion of XRT
Hide Outcome Measure Data
Hide Analysis Population Description
Assays were not analyzed due to lack of funding.
Arm/Group Title Placebo Curcumin
Hide Arm/Group Description:

Placebo

Placebo: daily placebo for 6 weeks

500 mg BID

Curcumin: 500 mg BID

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Primary Outcome
Title Plasma IL-6 Measured in pg/ml
Hide Description The primary outcome to be measured will be the change in plasma IL-6 after six weeks of treatment with daily placebo or Meriva.
Time Frame Baseline, 6 weeks following completion of XRT
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Curcumin
Hide Arm/Group Description:

Placebo

Placebo: daily placebo for 6 weeks

500 mg BID

Curcumin: 500 mg BID

Overall Number of Participants Analyzed 13 15
Mean (Standard Deviation)
Unit of Measure: pg/mL
Baseline 2.29  (3.26) 1.84  (1.32)
6 weeks post-treatment 2.04  (2.36) 1.77  (1.59)
6.Primary Outcome
Title Plasma C-reactive Protein (CRP) Measured in mg/L
Hide Description The primary outcome to be measured will be the change in plasma CRP after six weeks of treatment with daily placebo or Meriva.
Time Frame Baseline, 6 weeks following completion of XRT
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Curcumin
Hide Arm/Group Description:

Placebo

Placebo: daily placebo for 6 weeks

500 mg BID

Curcumin: 500 mg BID

Overall Number of Participants Analyzed 13 15
Mean (Standard Deviation)
Unit of Measure: mg/L
Baseline 2.71  (2.97) 2.72  (3.48)
6 weeks post-treatment 3.85  (4.36) 2.30  (2.95)
7.Secondary Outcome
Title Fatigue
Hide Description 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.
Time Frame Baseline, 6 weeks following completion of XRT
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Curcumin
Hide Arm/Group Description:

Placebo

Placebo: daily placebo for 6 weeks

500 mg BID

Curcumin: 500 mg BID

Overall Number of Participants Analyzed 13 15
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 56.69  (15.70) 57.40  (13.30)
6 weeks post-treatment 50.23  (13.86) 46.67  (13.62)
Time Frame 6 weeks
Adverse Event Reporting Description Events were assessed during weekly telephone calls with participants while they were on the study protocol. All adverse events were collected using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
 
Arm/Group Title Placebo Curcumin
Hide Arm/Group Description

Placebo

Placebo: daily placebo for 6 weeks

500 mg BID

Curcumin: 500 mg BID

All-Cause Mortality
Placebo Curcumin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)      0/15 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Curcumin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      2/15 (13.33%)    
Cardiac disorders     
Chest Pain *  0/15 (0.00%)  0 1/15 (6.67%)  1
Injury, poisoning and procedural complications     
Motor vehicle accident *  0/15 (0.00%)  0 1/15 (6.67%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Curcumin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/15 (80.00%)      13/15 (86.67%)    
Blood and lymphatic system disorders     
Anemia *  1/15 (6.67%)  1 0/15 (0.00%)  0
Leukopenia *  0/15 (0.00%)  0 1/15 (6.67%)  1
Cardiac disorders     
Heart murmur/Palpitations *  0/15 (0.00%)  0 2/15 (13.33%)  2
High Blood pressure *  0/15 (0.00%)  0 1/15 (6.67%)  4
Ear and labyrinth disorders     
Ear pain *  0/15 (0.00%)  0 1/15 (6.67%)  1
Gastrointestinal disorders     
Reflux/Indigestion *  0/15 (0.00%)  0 1/15 (6.67%)  1
Gastroenteritis *  0/15 (0.00%)  0 1/15 (6.67%)  1
Stomach Pain *  3/15 (20.00%)  3 2/15 (13.33%)  2
Nausea *  4/15 (26.67%)  4 5/15 (33.33%)  7
Stool change/Flatulence *  5/15 (33.33%)  5 3/15 (20.00%)  3
General disorders     
Headache *  5/15 (33.33%)  5 3/15 (20.00%)  5
Vertigo/ Dizziness *  0/15 (0.00%)  0 2/15 (13.33%)  3
Toothache *  1/15 (6.67%)  1 0/15 (0.00%)  0
Chills/Hot flashes *  4/15 (26.67%)  4 4/15 (26.67%)  4
Fatigue *  2/15 (13.33%)  2 2/15 (13.33%)  2
Swollen Glands *  0/15 (0.00%)  0 1/15 (6.67%)  1
Infections and infestations     
Abscess *  1/15 (6.67%)  1 0/15 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Joint pain *  4/15 (26.67%)  4 1/15 (6.67%)  1
Muscle pain *  6/15 (40.00%)  7 0/15 (0.00%)  0
Fractured elbow *  0/15 (0.00%)  0 1/15 (6.67%)  1
Nervous system disorders     
Memory impairment *  1/15 (6.67%)  1 1/15 (6.67%)  1
Insomnia *  1/15 (6.67%)  1 3/15 (20.00%)  3
Anxiety/Irritability/Mood change *  1/15 (6.67%)  1 3/15 (20.00%)  3
Neuropathy *  0/15 (0.00%)  0 1/15 (6.67%)  1
Carpal tunnel *  1/15 (6.67%)  1 0/15 (0.00%)  0
Renal and urinary disorders     
Urinary tract infection *  0/15 (0.00%)  0 1/15 (6.67%)  1
Reproductive system and breast disorders     
Menstrual changes *  4/15 (26.67%)  4 1/15 (6.67%)  1
Vaginal dryness *  0/15 (0.00%)  0 1/15 (6.67%)  1
Breast discomfort/pain *  3/15 (20.00%)  3 1/15 (6.67%)  1
Respiratory, thoracic and mediastinal disorders     
Cough *  1/15 (6.67%)  1 1/15 (6.67%)  1
Nasal symptoms *  6/15 (40.00%)  7 5/15 (33.33%)  5
Sore/itchy throat *  4/15 (26.67%)  4 5/15 (33.33%)  5
Wheezing *  1/15 (6.67%)  1 0/15 (0.00%)  0
Upper respiratory infection *  0/15 (0.00%)  0 1/15 (6.67%)  1
Skin and subcutaneous tissue disorders     
Skin irritation *  2/15 (13.33%)  2 1/15 (6.67%)  1
Pruritus *  0/15 (0.00%)  0 6/15 (40.00%)  6
Cold sore *  1/15 (6.67%)  1 0/15 (0.00%)  0
Blisters *  0/15 (0.00%)  0 1/15 (6.67%)  1
Nail loss *  0/15 (0.00%)  0 1/15 (6.67%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Andrew Miller, MD
Organization: Emory University
Phone: 404-727-8260
EMail: amill02@emory.edu
Layout table for additonal information
Responsible Party: Andrew H Miller, Emory University
ClinicalTrials.gov Identifier: NCT01740323     History of Changes
Other Study ID Numbers: IRB00055328
Winship2139-11 ( Other Identifier: Other )
R21CA178603 ( U.S. NIH Grant/Contract )
First Submitted: November 30, 2012
First Posted: December 4, 2012
Results First Submitted: July 16, 2019
Results First Posted: September 18, 2019
Last Update Posted: September 18, 2019