Involvement of Endogenous Digitalis-like Compounds in Breast Cancer

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ClinicalTrials.gov Identifier: NCT00310882

Recruitment Status : Withdrawn (the PI is no longer work at Hadassah)

First Posted : April 5, 2006

Last Update Posted : April 8, 2011

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Sponsor:

Information provided by:

Hadassah Medical Organization

Study Description

Brief Summary:

The endogenous digitalis-like compounds (DLC)are steroid hormones synthesized and released from the adrenal gland.They are integrated in the feed-back system of the Hypothalami-Pituitary-Adrenal gland axis.One of their remarkable function is to induce apoptosis in malignant cells. Recently, accumulating data point to the possibility of using synthetic DLC as new anti-cancer drugs. Less is known about the endogenous metabolism of these compounds in cancer patients.

Proceeding from preliminary clinical data which demonstrated significantly reduced DLC plasma levels in breast cancer patients and from in vitro data which showed an impaired release of DLC towards stress stimuli in athymic nude mice,we put up the hypothesis that a latent adrenal insufficiency with low DLC levels facilitates the induction and progression of tumor diseases.

Condition or disease
Breast Neoplasms Fibrocystic Disease of Breast Mammaplasty

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Detailed Description:

To pursue this question about endogenous DLC metabolism in cancer patients we intend to start with the measurement of DLC plasma levels in breast cancer patients at the time of first diagnosis and compare them to women with benign breast disease as well as healthy women.

Aim of the Study

To evaluate the basal DLC plasma concentrations in cancer patients at the time of first diagnosis and the function of the HPA axis, with focussing on breast cancer patients.
To analyze a potential change of HPA function and, in parallel, DLC plasma concentrations in the course of therapy, with special respect to treatment failure.
To establish a potential correlation between DLC plasma concentrations and risk factors in BC.

Patients and Methods

Patients:

I. 50 - (100) patients with breast cancer at the time of first diagnosis

II. 50 - (100) patients with a benign disease of the breast

III. 50 - (100) women undergoing plastic surgery of the breast

IV. 50 - (100) women who need no further exploration after visit in ambulance (=normal population)

V. additionally a group of 25 - 50 students (age 20-40) will be analyzed in a pilot study

Methods:

Time-schedule for Group I (Group II. - IV. alike, according to disease and/or situation)

Day of first presentation of the woman at the clinic
Day of first diagnosis, i.e. biopsy/FNA
Day of start of treatment: operation, chemo-/radiotherapy (tst = 0)
Day + 30, + 60, + 90
6 month and 1 year after start of treatment

The Group V. (students) will be analyzed in a special schedule, preceding the study 1-2 months:

4 weeks before an important exam
a day before the exam (-3 days)
a day after the exam (+ 3 days)
2 weeks after the exam
6 weeks after the exam

Parameters

Biochemistry (Group I. - V.)

Basal DLC plasma concentration
Basal serum Cortisol concentration
Basal plasma ATCH concentration
Basal Aldosterone/Renin concentration
Electrolytes (potassium, sodium, calcium, chloride)

Pathology/Immunohistochemistry (Group I. + II., when benign, including last 4 points)

Tumor size
lymph node status
E/P receptors
Grade
HER2/neu
Bcl-2
Ki67
p53

Radiology (Group I.)

If abdominal CT available measurement of size of the adrenal glands

Endocrinologic tests (Group I. - IV.)

Dexamethasone-test (low dose):
- 2 mg Dexamethasone p.o. at 24:00
- measurement of Cortisol and DLC at 8:00 the next morning
ACTH-test:
- basal plasma concentrations of Cortisol, DLC and ACTH
- administration of 250 µg ACTH (Synachten®) i.v.
- measurement of Cortisol and DLC after 30 min. and 60 min.
Facultative: Metapyrone test

at following time intervals:

Dexamethasone-test
- around the time of first presentation (± 5 days)
- around the time of start of treatment (± 5 days); corresponding times for Group II.- IV.
- Day + 30, +60, +90
- 6 month and a year after start of treatment
ACTH-test
- On the day of first presentation
- On the day of start of treatment; corresponding times for Group II.- IV.
- Day + 30, +60, +90
- 6 months and one year after start of treatment

Psychometric test for Stress Evaluation (Group I. - V.)

at the day of first presentation (Students: in between the last 2 weeks before an exam)
at the end of the study

Study Design

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Study Type :	Observational
Estimated Enrollment :	250 participants
Observational Model:	Case-Control
Time Perspective:	Prospective
Official Title:	Involvement of Endogenous Digitalis-like Compounds in Breast Cancer
Study Start Date :	May 2006
Estimated Study Completion Date :	May 2008

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Breast cancer Cystic fibrosis

MedlinePlus related topics: Breast Cancer

Drug Information available for: Digitalis

Genetic and Rare Diseases Information Center resources: Cystic Fibrosis

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Biospecimen Retention: Samples Without DNA

blood samples

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Women with first diagnosis of Breast Cancer or a benign Breast Disease

Criteria

Inclusion Criteria:

first visit to a Breast Disease Ambulance for consultation
no pregnancy

Exclusion Criteria:

no severe heart disease (EF > 40%)
no therapy with digitalis
no acute/chronic inflammatory disease (e.g. RA, M. Crohn)
no dysfunction of the Hypothalamo-Pituitary-Adrenal system
no severe mental disorder

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00310882

Locations

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Israel
Hadassah Hebrew University Medical Centers
Jerusalem, Israel

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

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Principal Investigator:	Heidrun Weideman	Hadassah Hebrew University Medical Centers

More Information

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Responsible Party:	Dr. Tanir Allweiss, Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00310882
Other Study ID Numbers:	297-31.3-06-HMO-CTIL
First Posted:	April 5, 2006 Key Record Dates
Last Update Posted:	April 8, 2011
Last Verified:	May 2008

Keywords provided by Hadassah Medical Organization:


breast cancer digitalis like compounds prognostic factor

Additional relevant MeSH terms:

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Breast Neoplasms Cystic Fibrosis Fibrocystic Breast Disease Breast Diseases Neoplasms by Site Neoplasms Skin Diseases	Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases

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