Trial Outcomes & Findings for Phase II Study of Curcumin vs Placebo for Chemotherapy-Treated Breast Cancer Patients Undergoing Radiotherapy (NCT NCT01740323)

NCT ID: NCT01740323

Last Updated: 2019-09-18

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 30 participants
• Primary outcome timeframe: Baseline, 6 weeks following completion of XRT
• Results posted on: 2019-09-18

Participant Flow

Participant milestones

Measure	Placebo Placebo Placebo: daily placebo for 6 weeks	Curcumin 500 mg BID Curcumin: 500 mg BID
Overall Study STARTED	15	15
Overall Study COMPLETED	13	15
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Placebo Placebo Placebo: daily placebo for 6 weeks	Curcumin 500 mg BID Curcumin: 500 mg BID
Overall Study Adverse Event	1	0
Overall Study Randomized but did not take study drug	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Placebo n=15 Participants Placebo Placebo: daily placebo for 6 weeks	Curcumin n=15 Participants 500 mg BID Curcumin: 500 mg BID	Total n=30 Participants Total of all reporting groups
Age, Continuous	51.87 years STANDARD_DEVIATION 10.67 • n=93 Participants	50.47 years STANDARD_DEVIATION 10.01 • n=4 Participants	51.17 years STANDARD_DEVIATION 10.19 • n=27 Participants
Sex: Female, Male Female	15 Participants n=93 Participants	15 Participants n=4 Participants	30 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=93 Participants	15 Participants n=4 Participants	30 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	7 Participants n=93 Participants	6 Participants n=4 Participants	13 Participants n=27 Participants
Race (NIH/OMB) White	7 Participants n=93 Participants	7 Participants n=4 Participants	14 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline, 6 weeks following completion of XRT

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.

Outcome measures

Measure	Placebo n=13 Participants Placebo Placebo: daily placebo for 6 weeks	Curcumin n=15 Participants 500 mg BID Curcumin: 500 mg BID
PBMC NF-kB DNA Binding Measured in ng/Well Baseline	9.01 ng/well Standard Deviation 14.70	9.56 ng/well Standard Deviation 5.63
PBMC NF-kB DNA Binding Measured in ng/Well 6 weeks post-treatment	17.54 ng/well Standard Deviation 9.24	16.04 ng/well Standard Deviation 16.13

PRIMARY outcome

Timeframe: Baseline, 6 weeks following completion of XRT

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.

Outcome measures

Measure	Placebo n=13 Participants Placebo Placebo: daily placebo for 6 weeks	Curcumin n=15 Participants 500 mg BID Curcumin: 500 mg BID
Plasma TNF-alpha Baseline	5.87 ng/well Standard Deviation 3.52	4.93 ng/well Standard Deviation 1.75
Plasma TNF-alpha 6 weeks post-treatment	4.93 ng/well Standard Deviation 1.75	5.24 ng/well Standard Deviation 0.97

PRIMARY outcome

Timeframe: Baseline, 6 weeks following completion of XRT

Population: Assays were not analyzed due to lack of funding.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, 6 weeks following completion of XRT

Population: Assays were not analyzed due to lack of funding.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, 6 weeks following completion of XRT

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

Outcome measures

Measure	Placebo n=13 Participants Placebo Placebo: daily placebo for 6 weeks	Curcumin n=15 Participants 500 mg BID Curcumin: 500 mg BID
Plasma IL-6 Measured in pg/ml Baseline	2.29 pg/mL Standard Deviation 3.26	1.84 pg/mL Standard Deviation 1.32
Plasma IL-6 Measured in pg/ml 6 weeks post-treatment	2.04 pg/mL Standard Deviation 2.36	1.77 pg/mL Standard Deviation 1.59

PRIMARY outcome

Timeframe: Baseline, 6 weeks following completion of XRT

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

Outcome measures

Measure	Placebo n=13 Participants Placebo Placebo: daily placebo for 6 weeks	Curcumin n=15 Participants 500 mg BID Curcumin: 500 mg BID
Plasma C-reactive Protein (CRP) Measured in mg/L Baseline	2.71 mg/L Standard Deviation 2.97	2.72 mg/L Standard Deviation 3.48
Plasma C-reactive Protein (CRP) Measured in mg/L 6 weeks post-treatment	3.85 mg/L Standard Deviation 4.36	2.30 mg/L Standard Deviation 2.95

SECONDARY outcome

Timeframe: Baseline, 6 weeks following completion of XRT

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.

Outcome measures

Measure	Placebo n=13 Participants Placebo Placebo: daily placebo for 6 weeks	Curcumin n=15 Participants 500 mg BID Curcumin: 500 mg BID
Fatigue Baseline	56.69 score on a scale Standard Deviation 15.70	57.40 score on a scale Standard Deviation 13.30
Fatigue 6 weeks post-treatment	50.23 score on a scale Standard Deviation 13.86	46.67 score on a scale Standard Deviation 13.62

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Curcumin

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=15 participants at risk Placebo Placebo: daily placebo for 6 weeks	Curcumin n=15 participants at risk 500 mg BID Curcumin: 500 mg BID
Cardiac disorders Chest Pain	0.00% 0/15 • 6 weeks 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.	6.7% 1/15 • Number of events 1 • 6 weeks 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.
Injury, poisoning and procedural complications Motor vehicle accident	0.00% 0/15 • 6 weeks 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.	6.7% 1/15 • Number of events 1 • 6 weeks 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.

Other adverse events

Measure	Placebo n=15 participants at risk Placebo Placebo: daily placebo for 6 weeks	Curcumin n=15 participants at risk 500 mg BID Curcumin: 500 mg BID
Respiratory, thoracic and mediastinal disorders Cough	6.7% 1/15 • Number of events 1 • 6 weeks 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.	6.7% 1/15 • Number of events 1 • 6 weeks 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.
Respiratory, thoracic and mediastinal disorders Nasal symptoms	40.0% 6/15 • Number of events 7 • 6 weeks 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.	33.3% 5/15 • Number of events 5 • 6 weeks 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.
Respiratory, thoracic and mediastinal disorders Sore/itchy throat	26.7% 4/15 • Number of events 4 • 6 weeks 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.	33.3% 5/15 • Number of events 5 • 6 weeks 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.
Respiratory, thoracic and mediastinal disorders Wheezing	6.7% 1/15 • Number of events 1 • 6 weeks 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.	0.00% 0/15 • 6 weeks 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.
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	0.00% 0/15 • 6 weeks 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.	6.7% 1/15 • Number of events 1 • 6 weeks 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.
Ear and labyrinth disorders Ear pain	0.00% 0/15 • 6 weeks 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.	6.7% 1/15 • Number of events 1 • 6 weeks 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.
Musculoskeletal and connective tissue disorders Joint pain	26.7% 4/15 • Number of events 4 • 6 weeks 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.	6.7% 1/15 • Number of events 1 • 6 weeks 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.
Musculoskeletal and connective tissue disorders Muscle pain	40.0% 6/15 • Number of events 7 • 6 weeks 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.	0.00% 0/15 • 6 weeks 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.
Musculoskeletal and connective tissue disorders Fractured elbow	0.00% 0/15 • 6 weeks 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.	6.7% 1/15 • Number of events 1 • 6 weeks 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.
Skin and subcutaneous tissue disorders Skin irritation	13.3% 2/15 • Number of events 2 • 6 weeks 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.	6.7% 1/15 • Number of events 1 • 6 weeks 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.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/15 • 6 weeks 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.	40.0% 6/15 • Number of events 6 • 6 weeks 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.
Skin and subcutaneous tissue disorders Cold sore	6.7% 1/15 • Number of events 1 • 6 weeks 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.	0.00% 0/15 • 6 weeks 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.
Skin and subcutaneous tissue disorders Blisters	0.00% 0/15 • 6 weeks 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.	6.7% 1/15 • Number of events 1 • 6 weeks 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.
Skin and subcutaneous tissue disorders Nail loss	0.00% 0/15 • 6 weeks 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.	6.7% 1/15 • Number of events 1 • 6 weeks 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.
Gastrointestinal disorders Reflux/Indigestion	0.00% 0/15 • 6 weeks 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.	6.7% 1/15 • Number of events 1 • 6 weeks 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.
Gastrointestinal disorders Gastroenteritis	0.00% 0/15 • 6 weeks 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.	6.7% 1/15 • Number of events 1 • 6 weeks 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.
Gastrointestinal disorders Stomach Pain	20.0% 3/15 • Number of events 3 • 6 weeks 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.	13.3% 2/15 • Number of events 2 • 6 weeks 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.
Gastrointestinal disorders Nausea	26.7% 4/15 • Number of events 4 • 6 weeks 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.	33.3% 5/15 • Number of events 7 • 6 weeks 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.
Gastrointestinal disorders Stool change/Flatulence	33.3% 5/15 • Number of events 5 • 6 weeks 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.	20.0% 3/15 • Number of events 3 • 6 weeks 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.
Renal and urinary disorders Urinary tract infection	0.00% 0/15 • 6 weeks 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.	6.7% 1/15 • Number of events 1 • 6 weeks 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.
Reproductive system and breast disorders Menstrual changes	26.7% 4/15 • Number of events 4 • 6 weeks 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.	6.7% 1/15 • Number of events 1 • 6 weeks 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.
Reproductive system and breast disorders Vaginal dryness	0.00% 0/15 • 6 weeks 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.	6.7% 1/15 • Number of events 1 • 6 weeks 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.
Reproductive system and breast disorders Breast discomfort/pain	20.0% 3/15 • Number of events 3 • 6 weeks 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.	6.7% 1/15 • Number of events 1 • 6 weeks 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.
General disorders Headache	33.3% 5/15 • Number of events 5 • 6 weeks 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.	20.0% 3/15 • Number of events 5 • 6 weeks 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.
General disorders Vertigo/ Dizziness	0.00% 0/15 • 6 weeks 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.	13.3% 2/15 • Number of events 3 • 6 weeks 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.
General disorders Toothache	6.7% 1/15 • Number of events 1 • 6 weeks 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.	0.00% 0/15 • 6 weeks 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.
General disorders Chills/Hot flashes	26.7% 4/15 • Number of events 4 • 6 weeks 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.	26.7% 4/15 • Number of events 4 • 6 weeks 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.
Cardiac disorders Heart murmur/Palpitations	0.00% 0/15 • 6 weeks 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.	13.3% 2/15 • Number of events 2 • 6 weeks 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.
Cardiac disorders High Blood pressure	0.00% 0/15 • 6 weeks 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.	6.7% 1/15 • Number of events 4 • 6 weeks 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.
Infections and infestations Abscess	6.7% 1/15 • Number of events 1 • 6 weeks 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.	0.00% 0/15 • 6 weeks 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.
Nervous system disorders Memory impairment	6.7% 1/15 • Number of events 1 • 6 weeks 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.	6.7% 1/15 • Number of events 1 • 6 weeks 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.
Nervous system disorders Insomnia	6.7% 1/15 • Number of events 1 • 6 weeks 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.	20.0% 3/15 • Number of events 3 • 6 weeks 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.
Nervous system disorders Anxiety/Irritability/Mood change	6.7% 1/15 • Number of events 1 • 6 weeks 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.	20.0% 3/15 • Number of events 3 • 6 weeks 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.
Nervous system disorders Neuropathy	0.00% 0/15 • 6 weeks 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.	6.7% 1/15 • Number of events 1 • 6 weeks 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.
Nervous system disorders Carpal tunnel	6.7% 1/15 • Number of events 1 • 6 weeks 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.	0.00% 0/15 • 6 weeks 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.
Blood and lymphatic system disorders Anemia	6.7% 1/15 • Number of events 1 • 6 weeks 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.	0.00% 0/15 • 6 weeks 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.
Blood and lymphatic system disorders Leukopenia	0.00% 0/15 • 6 weeks 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.	6.7% 1/15 • Number of events 1 • 6 weeks 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.
General disorders Fatigue	13.3% 2/15 • Number of events 2 • 6 weeks 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.	13.3% 2/15 • Number of events 2 • 6 weeks 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.
General disorders Swollen Glands	0.00% 0/15 • 6 weeks 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.	6.7% 1/15 • Number of events 1 • 6 weeks 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.

Additional Information

Andrew Miller, MD

Emory University

Phone: 404-727-8260

Email: amill02@emory.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place