Trial Outcomes & Findings for A Pilot Study of Chemo-prevention of Green Tea in Women With Ductal Carcinoma in Situ (NCT NCT01060345)

NCT ID: NCT01060345

Last Updated: 2020-04-09

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: Prior to starting study and after 4-6 weeks of treatment
• Results posted on: 2020-04-09

Participant Flow

Participant milestones

Measure	Women With Ductal Carcinoma in Situ Women who have been diagnosed with ductal carcinoma in situ (DCIS) and will be taking Polyphenon E Polyphenon E: three 200mg capsules (600mg total dose of the study drug) with food (within one hour of eating a substantial meal) daily for a minimum of 4 weeks, or until the day before surgery
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Study of Chemo-prevention of Green Tea in Women With Ductal Carcinoma in Situ

Baseline characteristics by cohort

Measure	Women With Ductal Carcinoma in Situ n=20 Participants Women who have been diagnosed with ductal carcinoma in situ (DCIS) and will be taking Polyphenon E Polyphenon E: three 200mg capsules (600mg total dose of the study drug) with food (within one hour of eating a substantial meal) daily for a minimum of 4 weeks, or until the day before surgery
Age, Continuous	56.8 years n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Prior to starting study and after 4-6 weeks of treatment

Population: 0 analyzed, data not collected as the study stopped early due to lack of drug supply

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Prior to study start and 4-6 weeks after treatment

Population: 0 analyzed, data not collected as the study stopped early due to lack of drug supply

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Prior to study start and 4-6 weeks after treatment

Population: 0 analyzed, data not collected as the study stopped early due to lack of drug supply

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Prior to study start and 4-6 weeks after treatment

Population: 0 analyzed, data not collected as the study stopped early due to lack of drug supply

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Prior to study start and after 4-6 weeks of treatment

Population: 0 analyzed, data not collected as the study stopped early due to lack of drug supply

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Prior to study start and after 4-6 weeks of treatment

Population: 0 analyzed, data not collected as the study stopped early due to lack of drug supply

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Number of patients with adverse event.

Outcome measures

Measure	Women With Ductal Carcinoma in Situ n=20 Participants Women who have been diagnosed with ductal carcinoma in situ (DCIS) and will be taking Polyphenon E Polyphenon E: three 200mg capsules (600mg total dose of the study drug) with food (within one hour of eating a substantial meal) daily for a minimum of 4 weeks, or until the day before surgery
Safety of Green Tea Ingestion	6 Participants

Adverse Events

Women With Ductal Carcinoma in Situ

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Women With Ductal Carcinoma in Situ n=20 participants at risk Women who have been diagnosed with ductal carcinoma in situ (DCIS) and will be taking Polyphenon E Polyphenon E: three 200mg capsules (600mg total dose of the study drug) with food (within one hour of eating a substantial meal) daily for a minimum of 4 weeks, or until the day before surgery
General disorders Fatigue	5.0% 1/20 • 6 weeks
Psychiatric disorders Anxiety	10.0% 2/20 • 6 weeks
Nervous system disorders Headache	10.0% 2/20 • 6 weeks
Gastrointestinal disorders Abdominal pain	5.0% 1/20 • 6 weeks
Reproductive system and breast disorders Breast pain	5.0% 1/20 • 6 weeks
Gastrointestinal disorders Constipation	5.0% 1/20 • 6 weeks
Gastrointestinal disorders Rectal hemorrhage	5.0% 1/20 • 6 weeks
Respiratory, thoracic and mediastinal disorders Cough	5.0% 1/20 • 6 weeks
Cardiac disorders Palpitations	5.0% 1/20 • 6 weeks
Respiratory, thoracic and mediastinal disorders Sore throat	5.0% 1/20 • 6 weeks

Additional Information

Nora Jaskowiak, MD

University of Chicago

Phone: 773-702-2048

Email: njaskowi@surgery.bsd.uchicago.edu

Results disclosure agreements

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