Symptoms and General Pathology

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Neoplasms

Skin and Connective Tissue Diseases

Recurrence

Carcinoma

Breast Neoplasms

Carcinoma in Situ

Breast Carcinoma In Situ

Hot Flashes

Carcinoma, Intraductal, Noninfiltrating

Carcinoma, Ductal, Breast

Breast Diseases

Skin Diseases

Herbal and Botanical

All Drugs and Chemicals

St. John's Wort

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

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

Michelle Naughton, PhD

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.

OBJECTIVES:

Primary

* Determine the efficacy of Hypericum perforatum (St. John's wort) in alleviating hot flashes, in terms of hot flash frequency, score, and duration and disruption of daily activities caused by hot flashes, in postmenopausal women with non-metastatic breast cancer.
* Determine hot flash changes over 4 weeks in patients treated with this drug.

Secondary

* Determine the toxicity of this drug in these patients.
* Determine the effect of Hypericum perforatum (St. John's wort) on serum tamoxifen levels in women receiving tamoxifen therapy.
* Determine the effect of Hypericum perforatum (St. John's wort) on general health-related quality of life and mood at 2 and 4 weeks relative to baseline, and during the 2 week post-treatment phase in these patients.
* To evaluate changes in average weekly hot flush scores and duration over course of study.

OUTLINE: This is a multicenter study.

Patients receive oral Hypericum perforatum (St. John's wort) three times daily for 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients complete a daily diary of the frequency, severity, and duration of their hot flashes, and complete quality of life and mood assessments every 2 weeks during study treatment and continuing weekly for 2 weeks after completion of study treatment.

Patients receiving tamoxifen will have blood tests to measure serum tamoxifen levels at baseline, 2, 4, and 6 weeks.

PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.

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

A Phase II Study of St. John's Wort for the Treatment of Hot Flashes in Women With a History of Breast Cancer

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

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.

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.

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.

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.

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.

National Cancer Institute (NCI)

Wake Forest University Health Sciences

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

Age, Categorical

Sex: Female, Male

White

Race/Ethnicity, Customized

United States

Region of Enrollment

All registered participants are used in the analysis.

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

Dr. Doug Case

Analysis of the change in hot flash frequency from baseline to four weeks; null hypothesis is no change.

Baseline

Four Weeks

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

Assessment of the change in the hot flash score over time

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

Estimation of Toxicities While on St. John's Wort

Assess the change in MCS from baseline to four weeks in patients receiving St. John's wort.

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

Assess the change in PCS from baseline to four weeks; null hypothesis is no change.

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

Assess the change in mood from baseline to four weeks. Null hypothesis is no change.

Patients 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.

Overall Study

Digestive System Diseases

Rare Diseases

Neoplasm Metastasis

Stomach Neoplasms

Peritoneal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Stomach Cancer

St. John's Wort 900 milligram once oral preoperative \& intraoperative irradiation with light (photodynamic diagnosis (PDD) and therapy (PDT), with the appropriate wavelength (390-440 nanometer) over 15 minutes

Single oral doses (900 milligram) 2-4 hours before laparoscopy

Intraoperative irradiation with light (photodynamic diagnosis (PDD) and therapy (PDT), with the appropriate wavelength (390-440 nanometer) over 15 minutes

Photodynamic diagnostic and therapy

Stefan Beckert, Prof. Dr.

Alfred Königsrainer, Prof. Dr.

The study would examine by hypericin-supported Fluoreszenzlaparoskopy in terms of tumor size, number and location of the combination of photodynamic diagnosis (PDD) and therapy (PDT) with regard to the detection of peritoneal metastases of locally advanced gastric cancer at 50 adult patients.

Hypericin-PDT study is an examination of patients with gastric cancer. The peritoneal carcinosis (PC) of the adult represents the final stage of an advanced tumor and was treated in the past, usually by means of palliative chemotherapy. An improvement in survival for patients with PC could be further improved through the use of maximum cytoreductive surgery (CRS) can be achieved with radical removal of the entire tumor mass and the combination of CRS and intraperitoneal hyperthermic chemotherapy (HIPEC) event-free survival and overall survival. A cure of patients is achieved only in the rarest cases. An essential problem in the treatment of peritoneal carcinomatosis is that can only be poorly differentiated from surrounding tissue due to their location, the tumors often not well recognized because of their size or. This results to differ (as scar tissue) for the surgeon the difficulty between eigentlichem tumor tissue and surrounding tissue.

Through the use of innovative diagnostic and therapeutic options (for example, photodynamic diagnosis (PDD) and therapy (PDT)) above mentioned problems can be improved. In photodynamic diagnosis contrast between tumor and surrounding healthy tissue is improved by an interaction of photodynamic active substance with light of a particular wavelength. The PDT is based on a topical or systemic administration of a photosensitizer (here hypericin), which is irradiated with light of a suitable wavelength and in the presence of oxygen oxygen radicals (with the consequence of a direct cytotoxicity of the tumor cells leading) forms.

The study will be carried out in the Department of General, Visceral and Transplantation Surgery Tübingen at 50 adult patients. The study proposed would examine by hypericin-supported Fluoreszenzlaparoskopy in terms of tumor size, number and location of the combination of photodynamic diagnosis (PDD) and therapy (PDT) with regard to the detection of peritoneal metastases of locally advanced gastric cancer.

Pilot Study on Intra-abdominal Photodynamic Diagnosis in Peritoneal Carcinosis

Detection of peritoneal metastases of locally - advanced gastric cancer by hypericin - supported Fluoreszenzlaparoskopie in terms of tumor size \[cm\]

Detection of peritoneal metastases of locally - advanced gastric cancer by hypericin - supported Fluoreszenzlaparoskopie in terms of number \[n\]

Detection of peritoneal metastases of locally - advanced gastric cancer by hypericin - supported Fluoreszenzlaparoskopie in terms of location \[central, right upper, epigastrium, left upper, , left flank, left lower, pelvis, riht lower, right flank, upper jejunum, lower jejunum, upper ileum, lower illeum\]

Hypericin levels in the peritoneum and serum the day of surgery

Histological evidence of apoptosis in peritoneal metastasis after photodynamic therapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
St. John's Wort in Relieving Hot Flashes in Postmenopausal Women With Non-Metastatic Breast Cancer	NCT00110136	Breast Cancer Hot Flashes	St. John's Wort	18 Years -	Wake Forest University Health Sciences
St. John's Wort in Relieving Hot Flashes in Postmenopausal Women With Non-Metastatic Breast Cancer	NCT00110136	Breast Cancer Hot Flashes	St. John's Wort	18 Years -	Wake Forest University Health Sciences
Pilot Study on Intra-abdominal Photodynamic Diagnosis in Peritoneal Carcinosis	NCT02840331	Peritoneal Carc...	St. John's Wort Photodynamic di...	18 Years -	University Hospital Tuebingen

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