Combination of Fermented Soy with Chemo-Therapy -Results of a Phase I Study -
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Transcript of Combination of Fermented Soy with Chemo-Therapy -Results of a Phase I Study -
Combination Combination of Fermented Soyof Fermented Soy with Chemo-Therapy with Chemo-Therapy
-Results of a Phase I Study --Results of a Phase I Study - Dr. Ursula Jacobs Dr. Ursula Jacobs
Klinik am Alpenpark Klinik am Alpenpark D-83707 Ringsee am TegernseeD-83707 Ringsee am Tegernsee
Germany Germany
PD Dr.Dr. Uwe D Rohr PD Dr.Dr. Uwe D Rohr
MED19 Medical CenterMED19 Medical CenterWien-GrinzingWien-Grinzing
Austria Austria
Vienna Dec. 7th 2007
Soy suppresses Soy suppresses Inflammation and CancerInflammation and Cancer
MAPK
NFkB
IL-6 APOPTOSIS
Soy-Isoflavones
Inflammation Cancer
MAPK
NFkB
IL-6 APOPTOSIS
Cancer
Inflammation Cancer CachexiaDepression Imhof et al, 2006
Haegemans et al, 2006Sartyr et al, 2007
MAPK
NFkB
IL-6 APOPTOSIS
Soy-Isoflavone
Inflammation Cancer
MAPK
NFkB
IL-6 APOPTOSIS
Cancer
Inflammation Cancer CachexiaDepression
Chemo-Therapy
Chemo-Therapy Chemo-Therapy increases Inflammation and Reduces Apoptosis increases Inflammation and Reduces Apoptosis
Imhof et al, 2006Haegemans et al, 2006Sartyr et al, 2007
MAPK
NFkB
IL-6 APOPTOSIS
Inflammation Cancer CachexiaDepression
Patient-CharacteristicsPatient-Characteristics
CancerCancer BreastBreast ProstateProstate OvarOvarNumberNumber 88 55 33
Age ( Years)Age ( Years)Min-Max(Years)Min-Max(Years)
585844 - 6644 - 66
585848 - 6348 - 63
5252
DiagnosisDiagnosisPrimary TumorPrimary Tumor(Years)(Years)Min-Max (Years)Min-Max (Years)
8,18,1
4,1 - 12.1 4,1 - 12.1
6,96,9
4,7 - 8,34,7 - 8,3
22
11
Patient with Patient with MetastasisMetastasis
6 out of 86 out of 8 4 out 54 out 5 --
Chemo.Chemo.TherapyTherapy(Years)(Years)Min-Max (Years)Min-Max (Years)
22
1,1 - 3,21,1 - 3,2
2,22,2
--
2,32,3
2-2,82-2,8
Tumor Breast Prostate Ovary
n = number of participants
8 5 3
ER-ß ?
ER- + + +
Her-2-Rec. - -
Apoptose
p21
VEGF - - -
Anti-angiogenese
+ + +
Phase I Study*
Summary of Molecular Results Summary of Molecular Results Combination-Therapy Combination-Therapy
Fermented Soy Fermented Soy ++ Chemo-Therapy Chemo-Therapy * 3Month Therapy
Rohr , et al 2007 , unpublished results
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Inhibition of Cell Cycle
IsoflavoneTamoxifen
Fermented Soy and ER-ß Expression in dissimated cells
n=5
ER-ßER-ß300
200
100
0 Zeit (Monate)
0 1,5 3
Patient consume Isoflavones regularly Patients with high GLEASON Factor(High Malignicy)
facher Anstieg
PSA-ValuePSA-Value300
200
100
0
Zeit (Monate)
0 1,5 3
Fermented Soy and Classical Cancer Parameter
Forschung und Praxis 435; 2006 S 16
Cachexia is the leading death among cancer patients
Cachexia:
Part of Aging Process Chronic Inflammatory Aging Diseases and Cancer: Chronic Inflammatory Aging Diseases and Cancer:
Estrogen-Receptor-Beta (ER-ß) Estrogen-Receptor-Beta (ER-ß) DeficienciesDeficiencies
ER-ß
Inflammation(IL-6, TNF-...)
Cancer
suppresses suppresses
Arteriosclerosis, Blood Pressure, Dementia, Osteoporosis, Cystitis , etc.
Cachexia
Cytocines cause CachexiaCytocines cause Cachexia
Morley et al Morley et al Am J Clin Nutr Am J Clin Nutr 2006;83:735– 432006;83:735– 43
Inflammation Marker TNF-Inflammation Marker TNF- can be reduced by Soy - Isoflavones can be reduced by Soy - Isoflavones
120 mg Genistein / day
n=16 postmenopausa women
Rohr , et al 2007 Times (Weeks)
Base line Isoflavone consumption after consumtion
Tumor Brust Prostata Ovar
n = Patienten 8 5 3
Reduction of Cachexia
+ + +
Increase of Apoptosis
+ + +
Phase I Study*
Cachexia and Apoptosis Cachexia and Apoptosis
Combination (Fermented Soy Combination (Fermented Soy ++ Chemo-Therapy) Chemo-Therapy)
* 3Month Therapy
Rohr , et al 2007 , unpublished data
Appetite Increaseby fermented Soy during Chemotherapy
in Breast Cancer Patients
13. Have you lacked appetite?
13. Have you lacked appetite?
Please answer all of the questions yourself by circling the number that best applies to you
Not at All
Little a Bit
Quite Very much
after 3 Month
EORTC QLQ-C30 (Version1)
Rohr , et al 2007 , nicht veröffentichte Ergebnisse
Body Weight Increase by fermented Soy and Chemotherapy
Mamma Ca
130
120
110
100
130
120
110
100
Body Weight Increase(%)
130
120
110
100
130
120
110
100
Body Weight Increase(%)
Prostate Ca
EORTC QLQ-C30 (Version1)
Rohr , et al 2007 , nicht veröffentichte Ergebnisse
130
120
110
100
130
120
110
100
Body Weight Increase(%)
Ovarian Ca
after 3 Month
Soy-Isoflavone do not act like Soy-Isoflavone do not act like Estrogens !!!Estrogens !!!
Cerebral hemisphäre :ER-ß Rezeptoren
cognition
Hypothalamus : ER-ß und Testosteron Rezeptoren
Ängstlichkeit, Depression, Stress, Stress, PMS, ADD/ADHD, Hormone Regulation & mehr
Stress reduction silences Immune-System
Stress accompanies Cancer
Psychotropic-Effects of Fermented Soyin Cancer Therapy
(with Chemo-Therapy) documented by a standardized Questionaire
EORTC QLQ-C30 (Version1)
23. Were you stressed ?
24. were you depressed ?
24. were you depressed ?
Uwe Rohr, unreported results, 2007
23. Were you stressed ?
Please answer all of the questions yourself by circling the number that best applies to you
Not at All
Little a Bit
Quite Very much
after 3 Month
after 3 Month
Mamma Ca
Mamma Ca
25. Did you have difficulties either memorize things or finding words ?
25. Did you have difficulties either memorize things or finding words ?
Please answer all of the questions yourself by circling the number that best applies to you
Not at All
Little a Bit
Quite Very much
Psychotropic-Effects of Fermented Soyin Cancer Therapy
(with Chemo-Therapy) documented by a standardized Questionaire
EORTC QLQ-C30 (Version1)
after 3 Month
Uwe Rohr, unreported results, 2007
ER-ß , ER-ß , ER-ER-
CNSER-ER-ß
ArteriesER-ß
Mamma ER-ER-ß
BladderER-ß
UterusER-
Ovaries ER-ER-ß
Bones ER-ER-ß
LungER-ER-ß
LiverER-
ColonER-ßER-
ProstateER-ER-ß
TesticlesER-ER-ß
Uwe D Rohr , GYNE 2006
-Cystitis (3 cases in breast cancer cases) -Cystitis (3 cases in breast cancer cases) -sleep improvement (8 x = 75 % of all -sleep improvement (8 x = 75 % of all participants) participants) -no poll allergy (5 cases) -no poll allergy (5 cases) -improved cognition (75%) -improved cognition (75%)
Joint painJoint pain-no pain in finger joints (2x)-no pain in finger joints (2x)-no backpain (1x) -no backpain (1x)
General observation in man and womenGeneral observation in man and women-Improved skin appearances -Improved skin appearances -improved nails and hairs -improved nails and hairs
Improvement of ER-ß related Diseases by Improvement of ER-ß related Diseases by fermented Soyfermented Soy
(Not including (Not including psychotropicpsychotropic effects) effects)
Patient U.L Patient U.L
Date of Birth.: 14.5.58
08/03 First Diagnosis: Mamma CA, Primary tumorTumor-Excission, plus Axilla-Dissection
6 x cycles Chemotherapie, 3 x cycles Zoladex 11/3 Liver metastasen, Chemo-Embolisation, Prof. Vogel , Frankfurt 01/05 Leber Metatstasen: komplette Remission of primary tumor
26.07.06 New liver Metastasis
Begin 04/07 HAELAN 951
25.4.2007 2.8.2007 12/07
Tumor-Size Reduction by Tumor-Size Reduction by Fermented SoyFermented Soy
0
5
Liver Tumor -Diameter (cm)
Fermented SoyStrong Mood Improvement
Depression
Fermented Soy Strong Mood Improvement
Patient U.L.Patient U.L.
Uwe Rohr et al, unreported results, 2007
25.4.2007 2.8.2007 12/07
Tumor-Size, Depression, Body-WeightTumor-Size, Depression, Body-Weight
And And fermented Soy fermented Soy
0
5
Liver Tumor -Diameter
(cm)
Fermented SoyFermented Soy
Body Weigth Improvement
(kg)
5kg
10kg
Strong depression
strong mood improvementstrong mood improvement
Uwe Rohr et al , unreported results, 2007
25.4.2007 2.8.2007 12/07
Can Dissiminated Breast Cancer-Cells be reduced by Can Dissiminated Breast Cancer-Cells be reduced by by fermented Soy ?by fermented Soy ?(Cancer Stem-Cells)(Cancer Stem-Cells)
0
5000
Fermented Soy Treatment
Patient SM, 48 Years
Cell Numbers per
(ml) ongoing
Uwe Rohr et al , unreported results, 2007
Fermented Soy
3 month
In blood
Metastasis
Invasive Cacinoma
Cavities
Residual-Tumor
Cavities
Residual-Tumor
Numbers
MalignityIn blood
Invasive Carcinoma
Metastasis
Phase I Study In Vienna
(Schematic description)
Cancer Stem-Cell
Less malignant Cancer Stem Cell
non cancerogenic cancer cell
non cancerogenic cancer cell