Trial Outcomes & Findings for St. John's Wort in Relieving Hot Flashes in Postmenopausal Women With Non-Metastatic Breast Cancer (NCT NCT00110136)

Results Overview

Primary objective was to assess the change in hot flashes over a four week period in patients given St. John's Wort

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

9 participants

Primary outcome timeframe

Baseline and four weeks

Results posted on

2021-09-29

Participant Flow

Participant milestones

Participant milestones
Measure	St. John's Wort Patient given one 300mg St. John's Wort tablet three times per day St. John's Wort: St. John's Wort 300mg tablet three times per day
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

St. John's Wort in Relieving Hot Flashes in Postmenopausal Women With Non-Metastatic Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	St. John's Wort n=9 Participants Patient given one 300mg St. John's Wort tablet three times per day St. John's Wort: St. John's Wort 300mg tablet three times per day
Age, Continuous	55.2 years STANDARD_DEVIATION 7.0 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized White	9 participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and four weeks

Population: All registered participants

Primary objective was to assess the change in hot flashes over a four week period in patients given St. John's Wort

Outcome measures

Outcome measures
Measure	St. John's Wort n=9 Participants Patient given one 300mg St. John's Wort tablet three times per day St. John's Wort: St. John's Wort 300mg tablet three times per day
Effect of St. John's Wort on Hot Flash Frequency as Recorded in a Daily Hot Flash Diary From Baseline to 4 Weeks Baseline	7.8 number of occurrences Standard Deviation 5.3
Effect of St. John's Wort on Hot Flash Frequency as Recorded in a Daily Hot Flash Diary From Baseline to 4 Weeks Four Weeks	7.0 number of occurrences Standard Deviation 5.3

SECONDARY outcome

Timeframe: Baseline and four weeks

Population: All registered participants

The hot flash score is calculated as the frequency of hot flashes times the severity of the hot flashes averaged over a week. Frequency is the number of hot flashes in a day. Severity is coded 0=None, 1=Mild, 2=Moderate, and 3=Severe. Score for each day is frequency times severity. Weekly score is averaged over seven days. Score ranges from 0 to infinity Lower scores are better.

Outcome measures

Outcome measures
Measure	St. John's Wort n=9 Participants Patient given one 300mg St. John's Wort tablet three times per day St. John's Wort: St. John's Wort 300mg tablet three times per day
Effect of St. John's Wort on Hot Flash Score as Recorded in a Daily Hot Flash Diary From Baseline to 4 Weeks Four Weeks	15.0 frequency times severity Standard Deviation 17.3
Effect of St. John's Wort on Hot Flash Score as Recorded in a Daily Hot Flash Diary From Baseline to 4 Weeks Baseline	19.4 frequency times severity Standard Deviation 17.5

SECONDARY outcome

Timeframe: Six weeks following baseline (four weeks of active treatment and two weeks of follow-up)

Population: All registered participants

Toxicities are quantified using the standard NCI toxicity criteria. The outcome is the percentage of participants who experience one or more toxicities. More detailed information on toxicities is found in the adverse events section.

Outcome measures

Outcome measures
Measure	St. John's Wort n=9 Participants Patient given one 300mg St. John's Wort tablet three times per day St. John's Wort: St. John's Wort 300mg tablet three times per day
Estimation of Toxicities While on St. John's Wort	66.67 percentage of participants Interval 29.93 to 92.51

SECONDARY outcome

Timeframe: Baseline and four weeks

Population: All registered participants.

Quality of life was measured by the SF12 (MCS and PCS subscales). First we'll summarize the MCS. SF-12 is the short form Health Survey (a short version of the SF-36) developed for the Medical Outcomes Study. It is managed by QualityMetric. MCS is the mental health component of the SF-12. A normal population has a mean of 50 and a SD of 10. Higher numbers represent better mental health. The range is 0 to 100. Higher scores represent better mental health.

Outcome measures

Outcome measures
Measure	St. John's Wort n=9 Participants Patient given one 300mg St. John's Wort tablet three times per day St. John's Wort: St. John's Wort 300mg tablet three times per day
Effect of St. John's Wort on Quality of Life (MCS) Baseline	53.3 units on a scale Standard Deviation 7.5
Effect of St. John's Wort on Quality of Life (MCS) Four Weeks	53.8 units on a scale Standard Deviation 4.0

SECONDARY outcome

Timeframe: Baseline and four weeks

Population: All registered participants.

Quality of life was measured by the SF12 (MCS and PCS subscales). Now we'll summarize the PCS. SF-12 is the short form Health Survey (a short version of the SF-36) developed for the Medical Outcomes Study. It is managed by QualityMetric. PCS is the physical health component of the SF-12. Normal population has a mean of 50 and a SD of 10. Higher scores reflect better physical health. The range is 0 to 100. Higher scores represent better mental health.

Outcome measures

Outcome measures
Measure	St. John's Wort n=9 Participants Patient given one 300mg St. John's Wort tablet three times per day St. John's Wort: St. John's Wort 300mg tablet three times per day
Effect of St. John's Wort on Quality of Life (PCS) Baseline	47.4 units on a scale Standard Deviation 12.6
Effect of St. John's Wort on Quality of Life (PCS) Four Weeks	47.4 units on a scale Standard Deviation 9.6

SECONDARY outcome

Timeframe: Baseline and four weeks

Population: All registered participants.

POMS stands for the Profile of Mood States This is a short version of the POMS (17 questions). Each question is scored on a 0 to 4 scale. The POMS score is the sum of the responses to the 17 questions. Responses to some questions have been reversed to make higher responses better. The range is 0 to 68. Higher scores represent better overall mood.

Outcome measures

Outcome measures
Measure	St. John's Wort n=9 Participants Patient given one 300mg St. John's Wort tablet three times per day St. John's Wort: St. John's Wort 300mg tablet three times per day
Mood is Measured by the POMS Short Form. Baseline	51.7 units on a scale Standard Deviation 8.4
Mood is Measured by the POMS Short Form. Four Weeks	56.1 units on a scale Standard Deviation 3.4

Adverse Events

St. John's Wort

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	St. John's Wort n=9 participants at risk Patient given one 300mg St. John's Wort tablet three times per day St. John's Wort: St. John's Wort 300mg tablet three times per day
Gastrointestinal disorders Diarrhea	11.1% 1/9 • Number of events 2 • Ten weeks
Nervous system disorders Dizziness	33.3% 3/9 • Number of events 4 • Ten weeks
Gastrointestinal disorders Dry Mouth	44.4% 4/9 • Number of events 9 • Ten weeks
General disorders Fatigue	22.2% 2/9 • Number of events 3 • Ten weeks
Nervous system disorders Headache	22.2% 2/9 • Number of events 3 • Ten weeks
General disorders Hot Flashes	11.1% 1/9 • Number of events 1 • Ten weeks
General disorders Insomnia	44.4% 4/9 • Number of events 7 • Ten weeks
General disorders Pain	11.1% 1/9 • Number of events 2 • Ten weeks
Eye disorders Photosensiivity	11.1% 1/9 • Number of events 1 • Ten weeks
Gastrointestinal disorders Proctitis	11.1% 1/9 • Number of events 1 • Ten weeks
Skin and subcutaneous tissue disorders Prutitus	22.2% 2/9 • Number of events 3 • Ten weeks
Skin and subcutaneous tissue disorders Rash	11.1% 1/9 • Number of events 2 • Ten weeks

Additional Information

Dr. Doug Case

Wake Forest CCOP Research Base

Phone: (336) 716-1048

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place