Breast NeoplasmsNCT00310882
Involvement of Endogenous Digitalis-like Compounds in Breast Cancer
An observational study of Breast Neoplasms and Fibrocystic Disease of Breast, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasms, Fibrocystic Disease of Breast, Mammaplasty
- How many people
- 250 participants
- Where
- 1 siteIsrael
- Study dates
- May 2006to May 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women with first diagnosis of Breast Cancer or a benign Breast Disease
Who may be able to join
- first visit to a Breast Disease Ambulance for consultation
- no pregnancy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- 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)
- 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
- Conditions
- Breast Neoplasms, Fibrocystic Disease of Breast, Mammaplasty
- Keywords
- breast cancer, digitalis like compounds, prognostic factor
- Medical subject headings
- Breast Neoplasms, Fibrocystic Breast Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2006 (estimated)
- Study startMay 2006
- Study completionMay 2008 (estimated)
Why it stopped: the PI is no longer work at Hadassah
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Heidrun Weideman, Principal investigator, Hadassah Hebrew University Medical Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00310882
- Sponsor's protocol ID
- 297-31.3-06-HMO-CTIL
- Status last verified
- May 2008
- First submitted
- 4 Apr 2006
- Last updated
- 8 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Involvement of Endogenous Digitalis-like Compounds in Breast Cancer
- ClinicalTrials.gov ID
- NCT00310882
- Acronym / sponsor ID
- 297-31.3-06-HMO-CTIL
- Conditions
- Breast Neoplasms, Fibrocystic Disease of Breast, Mammaplasty
- Keywords
- breast cancer, digitalis like compounds, prognostic factor
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: the PI is no longer work at Hadassah
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- May 2006
- Study completion
- May 2008 (estimated)
- First posted
- 5 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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)
- 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
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women with first diagnosis of Breast Cancer or a benign Breast Disease
Key inclusion criteria (2 listed)
- first visit to a Breast Disease Ambulance for consultation
- no pregnancy
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heidrun Weideman principal investigator
Hadassah Hebrew University Medical Centers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms and Fibrocystic Disease of Breast, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2011.