NCT00110136

Brief Summary

RATIONALE: St. John's wort may help relieve hot flashes in women with breast cancer. PURPOSE: This phase II trial is studying how well St. John's wort works in relieving hot flashes in women with non-metastatic breast cancer.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Mar 2006

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

19 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2005

Completed
11 months until next milestone

Study Start

First participant enrolled

March 16, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
6.7 years until next milestone

Results Posted

Study results publicly available

December 29, 2014

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

2 years

First QC Date

May 3, 2005

Results QC Date

September 4, 2014

Last Update Submit

September 28, 2021

Conditions

Breast CancerHot Flashes

Keywords

recurrent breast cancerstage I breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerbreast cancer in situductal breast carcinoma in situhot flashes

Outcome Measures

Primary Outcomes (1)

  • Effect of St. John's Wort on Hot Flash Frequency as Recorded in a Daily Hot Flash Diary From Baseline to 4 Weeks

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

    Baseline and four weeks

Secondary Outcomes (5)

  • Effect of St. John's Wort on Hot Flash Score as Recorded in a Daily Hot Flash Diary From Baseline to 4 Weeks

    Baseline and four weeks

  • Estimation of Toxicities While on St. John's Wort

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

  • Effect of St. John's Wort on Quality of Life (MCS)

    Baseline and four weeks

  • Effect of St. John's Wort on Quality of Life (PCS)

    Baseline and four weeks

  • Mood is Measured by the POMS Short Form.

    Baseline and four weeks

Study Arms (1)

St. John's Wort

EXPERIMENTAL

Patient given one 300mg St. John's Wort tablet three times per day

Drug: St. John's Wort

Interventions

St. John's WortDRUG

St. John's Wort 300mg tablet three times per day

St. John's Wort

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age
  • and over
  • Sex
  • Female
  • Menopausal status
  • Post-menopausal (i.e., no menstrual periods ≥ 12 months or surgical menopause)
  • Performance status
  • ECOG 0-2
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Not specified
  • Hepatic
  • Bilirubin \< 2 mg/dL
  • SGOT ≤ 2 times normal
  • +2 more criteria

You may not qualify if:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No history of intolerance to St. John's wort
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • Not specified
  • Chemotherapy
  • No concurrent cytotoxic chemotherapy
  • Endocrine therapy
  • No concurrent selective estrogen-receptor modulators or aromatase inhibitors (e.g., anastrozole, letrozole, or exemestane) allowed
  • Concurrent tamoxifen allowed
  • No concurrent estrogen, progestational agents, or androgens for the alleviation of hot flashes
  • No concurrent corticosteroids
  • Radiotherapy
  • Not specified
  • +27 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Helen F. Graham Cancer Center at Christiana Hospital

Newark, Delaware, 19713, United States

Location

MBCCOP - Howard University Cancer Center

Washington D.C., District of Columbia, 20060, United States

Location

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, 33136, United States

Location

CCOP - Central Illinois

Decatur, Illinois, 62526, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

Feist-Weiller Cancer Center at Louisiana State University Health Sciences

Shreveport, Louisiana, 71130-3932, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

CCOP - Beaumont

Royal Oak, Michigan, 48073-6769, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Cancer Research for the Ozarks

Springfield, Missouri, 65804, United States

Location

CCOP - St. Louis-Cape Girardeau

St Louis, Missouri, 63141, United States

Location

Alamance Cancer Center at Alamance Regional Medical Center

Burlington, North Carolina, 27216, United States

Location

Hugh Chatham Memorial Hospital

Elkin, North Carolina, 28621, United States

Location

CCOP - Southeast Cancer Control Consortium

Goldsboro, North Carolina, 27534-9479, United States

Location

Leo W. Jenkins Cancer Center at ECU Medical School

Greenville, North Carolina, 27835-6028, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

South Carolina Cancer Specialists

Hilton Head Island, South Carolina, 29925, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsHot FlashesBreast Carcinoma In SituCarcinoma, Intraductal, Noninfiltrating

Interventions

Hypericum extract LI 160

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCarcinoma in SituCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeAdenocarcinomaNeoplasms, Ductal, Lobular, and Medullary

Limitations and Caveats

This study was stopped early due to concerns about the interaction between St. John's wort and tamoxifen.

Results Point of Contact

Title
Dr. Doug Case
Organization
Wake Forest CCOP Research Base
dcase@wakehealth.edu
(336) 716-1048

Study Officials

  • Michelle Naughton, PhD

    Wake Forest University Health Sciences

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2005

First Posted

May 4, 2005

Study Start

March 16, 2006

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

September 29, 2021

Results First Posted

December 29, 2014

Record last verified: 2021-09

Locations

US(19)