IncobotulinumtoxinA (Xeomin®, Merz) (INA) will be reconstituted with preservative-free normal saline to a dilution of 5mL:100 units.
Study participants in this arm will receive 50u INA (total volume 2.5mL) injected into each limb, max 2 limbs per subject (either bilateral hands or bilateral feet.)
Hands: INA will be injected across the palmar surface of the digits in a grid like pattern covering a total of 25 sites per limb (0.1mL/site).
Feet: INA will be injected across the dorsal surface of the feet also in a grid like pattern covering a total of 25 sites per limb (0.1mL/site).

Study participants in this arm will 2.5mL normal saline injected into each limb, max 2 limbs per subject (either bilateral hands or bilateral feet.)
Hands: saline will be injected across the palmar surface of the digits in a grid like pattern covering a total of 25 sites per limb (0.1mL/site).
Feet: Saline will be injected across the dorsal surface of the feet also in a grid like pattern covering a total of 25 sites per limb (0.1mL/site).

Peripheral Neuropathy Due to Chemotherapy

IncobotulinumtoxinA (Xeomin®, Merz) (INA) will be reconstituted with preservative-free normal saline to a dilution of 5mL:100 units. Study participants will receive 50u INA (total volume 2.5mL) injected into each limb, max 2 limbs per subject (either bilateral hands or bilateral feet.) Study participants will receive one series of injections during the trial. In the hands, INA will be injected across the palmar surface of the digits in a grid like pattern covering a total of 25 sites per limb (0.1mL/site). In the feet, INA will be injected across the dorsal surface of the foot in a grid like pattern covering a total of 25 sites per limb (0.1mL/site). Injections will be performed intradermally using a 5/16-inch, 32-g needle

IncobotulinumtoxinA (Xeomin®, Merz) (INA)

Study participants will total volume 2.5mL of 0.9% Normal saline injected into each limb, max 2 limbs per subject (either bilateral hands or bilateral feet.) Study participants will receive one series of injections during the trial. In the hands, 0.9% Normal saline will be injected across the palmar surface of the digits in a grid like pattern covering a total of 25 sites per limb (0.1mL/site). In the feet, 0.9% Normal saline will be injected across the dorsal surface of the foot in a grid like pattern covering a total of 25 sites per limb (0.1mL/site). Injections will be performed intradermally using a 5/16-inch, 32-g needle

Normal saline

Botox® [package insert]. Irvine, CA: Allergan, Inc; 2011

Froedtert Hospital

Botulinum Toxin A for the Treatment of Chemotherapy Induced Peripheral Neuropathy

The primary outcome of this study will be the change pain as measured by the NPS at 8 weeks post intervention as compared to baseline NPS scores. The NPS is a validated scale that is used to classify patient's neuropathic pain. It includes assessment of global pain intensity and pain unpleasantness, two items addressing the location of the pain as deep or surface, and six items addressing the specific qualities of neuropathic such as sharp, hot, dull, cold, sensitivity, and itchy.

Change pain as measured by the NPS at additional time points: 2weeks, 4 weeks, 12 weeks, 6 months when compared to baseline scores.

Change in the pain characteristics as measured by each NPS domain when compared to baseline at additional time points: 2weeks, 4 weeks, 8 weeks, 12 weeks, 6 months. Domains include: assessment of global pain intensity and pain unpleasantness, two items addressing the location of the pain as deep or surface, and six items addressing the specific qualities of neuropathic such as sharp, hot, dull, cold, sensitivity, and itchy.

Change in the Neuropathic Pain Impact on Quality of Life (NePIQoL) score at time points: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months. The NePIQoL is a validated scale comprised of 42 items organized into 7 categories of questions affecting quality of life: symptoms, relationships, psychological, social activity, physical change, personal care, overall health and overall quality of life

incidence of treatment related adverse events within each cohort

Erin McGonigle

Assistant Professor

Medical College of Wisconsin

Examination of participants prior to chemotherapy. Venous occlusion plethysmography SphygmoCor 24hour blood pressure DEXA scan Laboratory blood samples

Examination of participants immediately after chemotherapy. Venous occlusion plethysmography SphygmoCor 24hour blood pressure DEXA scan Laboratory blood samples

Examination of participants one year after chemotherapy. Venous occlusion plethysmography SphygmoCor 24hour blood pressure DEXA scan Laboratory blood samples

Breast Neoplasms

Endothelial Dysfunction

Cardiovascular Disease

Metabolic Syndrome

To characterize endothelial function in vivo the effect of vasodilatating substances is measured in the forearm circuit. The substances is administered via a thin catheter placed in the Brachial artery near the elbow in local anesthesia. Once the vessels dilate, the blood flow in the forearm will increase and the flow change is a measure of the vasodilatory capacity of that substance. The change is measured with classical venous occlusion plethysmography. The method described is established at Aarhus University Hospital and has been used for several decades to illustrate the effect of vasoactive drugs on the human circulation, meaning it is a proven and well documented method.

Venous occlusion plethysmography

Applanation tonometry (pulse wave velocity and central blood pressure/arterial stiffness): The central blood pressure and the augmentation index is estimated from the shape of the radial pulse wave measured with a tonometer.
Pulse wave velocity (PWV) is calculated from the average difference between the pulse pressure wave measured with a tonometer and the R in an ECG recorded simultaneously.

SphygmoCor

24hour blood pressure

Measurements of body composition: Total body fat and fat free mass is measured by Dual Energy X-ray Absorptiometry (DEXA).

DEXA scan

Fasting blood tests are drawn from an antecubital placed catheter (albumin, ALAT/ASAT, alkaline phosphatase, bilirubin, gammaglutamyl transferase, coagulation factors, red and white blood cells, creatinin, potassium, sodium, fasting lipids, fasting glucose, hemoglobin A1C, insulin, sex hormones, von Willebrand factor, low grade inflammation markers, DNA and RNA for later analyses, including relevant coding genes).
Further more urine samples to determine possible systemic impact of cardiovascular disease.
We will create a biobank containing urine and blood samples from participants for future research, provided that the participant gives her permission.
Responsibility for the biobank lies with the project responsible physician, Anders Bonde Jensen.

Laboratory blood samples

Aarhus University Hospital

Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium

P-Kolesterol, P-Kolesterol HDL, P-Kolesterol LDL, P-Triglyceride, P-Glukose, P-Progesteron, P-Testosteron, P-Von Willebrand-faktor, P-Natrium, P-Kalium, P-Kreatinin and P-Østradiol.

The SCORE-system is a well- established and validated method using age, gender, smoking status, systolic blood pressure and plasma cholesterol for risk stratification.

University of Aarhus

Danish Cancer Society

Type II Diabetes Mellitus

30 drops in 1 cup of water three times a day for 3 months

Abroma Augusta Q (mother tincture)

,Father Muller Homoeopathic Medical College, Prasanth Nivas Ashram Nmpt Hospital

Therapeutic Efficacy of "Abroma Agusta" in HbA1c % in NIDDM

Therapeutic Efficacy of Homoeopathic Mother Tincture of "Abroma Agusta" in Changing the Level of Glycated Hb (HbA1c %) in Diabetes Mellitus Type II (NIDDM

alkaloid/i̇nme

Botulinum Toxin A for the Treatment of Chemotherapy Induced Peripheral Neuropathy

Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium

Therapeutic Efficacy of "Abroma Agusta" in HbA1c % in NIDDM

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