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Program in Integrative Medicine

Research

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The following research studies are currently being conducted in the Program in Integrative Medicine. If you are interested in participating, please call 913-588-6104 to leave your contact information. A study representative will contact you shortly.

Evaluation of Bioidentical Hormones in Early Menopause

Now Recruiting

http://www.clinicaltrials.gov/ct/show/NCT00302731?order=1

This pilot study is designed as a prospective double blind, placebo controlled study comparing 4 groups of women who are within 7 years of menopause. There will be 10 women in each of the 4 groups with a total of 40 women enrolled and these women will be treated for 12 months.

The Long-Term Goal is to provide health care practitioners and consumers with evidence-based recommendations for the use of bioidentical hormone replacement.

The Short-Term Goal of this pilot study is to provide safety information for bioidentical hormone use by evaluating surrogate markers for cardiovascular disease (lipid levels), with secondary evaluation of breast (mammogram) and uterus (endovaginal ultrasound), and to collect information about bone preservation.

The Hypothesis is: bioidentical hormone replacement therapy provides a safe alternative to standard hormone replacement therapy.

To test this hypothesis the following Specific Aim has been identified:  To determine if bioidentical hormone replacement therapy is associated with improved lipid profiles (surrogate marker for cardiovascular disease) when compared to Prempro. This will be determined by evaluating lipid levels at baseline and during the 12-month treatment period.

Inclusion Criteria:

  • Female
  • Ambulatory
  • Within 7 years post menopause
  • Positive history of menopausal symptoms such as vasomotor symptoms or osteoporosis in a study subject unable to tolerate bisphosphonates
  • FSH greater than 20 mIU/mL
  • Intact uterus and at least one intact ovary
  • Amenorrhea for 3 months or greater up to 7 years
  • Normal pap smear results within 12 months
  • Normal mammogram result within 12 months
  • Agreeable to a 3 month washout period with no hormones prior to entering the trial
  • Women who have no language barrier, are cooperative, and who can give informed consent before entering this study

Exclusion Criteria:

  • Unwilling to take hormone replacement for the 12 month period
  • Evidence of clinically significant psychiatric disorder by history/examination that would prevent the patient from completing the study.
  • Active deep venous thrombosis, pulmonary embolism, or a history of these conditions
  • Active or recent arterial thromboembolic disease
  • Undiagnosed vaginal bleeding
  • Hypersensitivity to ingredients in Prempro
  • Patients with known current bone disorders other than primary osteoporosis
  • Patients with pathological fractures
  • Patients with suspected or history of carcinoma of the breast or estrogen dependent neoplasms such as endometrial carcinoma.
  • Patients who have ≥ 5mm endometrial thickness by endovaginal (transvaginal) ultrasound.
  • Patients who have impaired renal function evidenced by serum creatinine greater than 2.5 mg/dL.
  • Patients who have impaired hepatic function evidenced by transaminase (AST/ALT) ≥2.5X upper limit
  • Patients with severe malabsorption syndromes.
  • Patients who consume an excess of alcohol or abuse drugs (an excess of alcohol is defined as more than four of any one or combination of the following per day: 30 mL distilled spirits, 340 mL beer, or 120 mL wine).
  • Patients who received any investigational drug within the proceeding month
  • tobacco use will not be allowed
  • Treatment with therapeutic doses of any of the following medications more recently than 3 months:
    • Estrogen
    • Callcitonin
    • Progestins
    • Androgen
    • SERMS
    • Bisphosphonates
    • Corticosteroids
    • Progesterone
    • Lithium
    • Heparin
    • Fluorides
    • Vitamin D - 50,000IU
    • Anticonvulsants
    • Herbal menopause treatments
    • Phosphate binding antacids

HDIVAA-Hepatitis C

The study is recruiting people with chronic (longstanding) hepatitis C who have failed treatment with the usual therapy (interferon and ribavirin). It is known that considerable numbers of people with cancer and chronic viral hepatitis are receiving high doses of intravenous vitamin C from physicians as a treatment.  When vitamin C is given in this manner, it is known that it acts like a drug and not a vitamin.  It is not proven in scientifically designed treatment studies that high doses of intravenous vitamin C are safe, although high doses of intravenous vitamin C have been given to patients for over 30 years. No formal study has been done at these high doses in patients with hepatitis C. Currently, the FDA has not approved the use of high dose intravenous vitamin C (given through a vein in your arm) as a hepatitis treatment.  High dose Vitamin C creates hydrogen peroxide around the infected cells. Researchers believe it is hydrogen peroxide that kills the virus. 

You will receive 30 treatments of intravenous vitamin C over a period of 20 weeks, plus one month of follow-up after treatment is completed. Your hepatitis doctor must know you are planning to participate in this study.  The study staff will notify your doctor by letter with your permission.  The dose of intravenous vitamin C will be started at 25 grams and may be increased up to 100 grams, until your blood level of vitamin C after the infusion reaches a predetermined level, which other studies have suggested suppresses the growth of the hepatitis C virus.  Each infusion will take from 50 to 200 minutes to complete.  You will receive infusions twice a week for 10 weeks and then once a week for another 10 weeks.

Pilot Study to Assess Precision and Reproducibility of an Erythrocyte ELISA Assay for Metallothionein.

Zinc is an essential trace mineral required for hundreds of reactions in the human body.  Zinc balance has therefore become a rich area for medical research.  Some people have zinc deficiency from trouble absorbing or storing zinc, and many studies now link zinc deficiency to many different human disorders.   We would like to learn how and why this happens, so we are trying to develop a new test to help us measure metallothionein, where zinc is stored.

We hypothesize that relative zinc deficiency is common, intimately relates to multiple, diverse disease states, and will be reflected by changes in metallothionein abundance.  Our specific aim is to perform a pilot study to establish the metallothionein test as an additional biomarker that can be used among a battery of tests to better evaluate a subject’s overall zinc status or response to therapy.

We anticipate the results of this study will be available by summer 2009, and hope to thereafter extend metallothionein testing to targeted populations.

Hecht Foundation:

(1) Safety and Effectiveness of Adding Intravenous Vitamin C to Gemcitabine Chemotherapy for Pancreatic Cancer, and (2) Assessing Pharmacokinetic and Pharmacodynamic Interactions When Adding Intravenous Ascorbate to Frontline Gemcitabine Chemotherapy in the Treatment of Locally Advanced or Metastatic Pancreatic Cancer

  1. We are proposing a study in advanced pancreatic cancer patients not eligible for surgical resection undergoing chemotherapy with a Primary Hypothesis that adding IV vitamin C to gemcitabine chemotherapy for pancreatic cancer will be safe and not inhibit the effectiveness of gemcitabine chemotherapy. We will determine if it is safe to combine gemcitabine chemotherapy with IV vitamin C. We will enroll up to 14 participants with pancreatic cancer. Safety will be assessed by obtaining the following evaluations: toxicity graded by the NCI CTC v 3.0, urinalysis pre- and post-infusion, ECG, basic metabolic panel, bicarbonate (pH surrogate marker), CBC, and osmolality. This protocol will be conducted in the General Clinical Research Center at the University of Kansas Medical Center.

  2. Assess pharmacokinetic and pharmacodynamic interactions when adding IV ascorbate to frontline gemcitabine chemotherapy in the treatment of locally advanced or metastatic pancreatic cancer not eligible for surgical resection. By measuring PK data when combining gemcitabine chemotherapy along with IV ascorbate on the same day, it will be determined if there are reduced gemcitabine levels in the presence of ascorbate. Initially 7 participants will be enrolled and if no significant interaction defined, an additional 7 will be enrolled. If deemed safe and no significant change identified in gemcitabine chemotherapy levels, the participants enrolled will be continued on the dual treatment plan of gemcitabine chemotherapy and IV ascorbate given on a prescribed schedule. The participants will be followed until there is progression of disease with a secondary hypothesis that there may be a benefit when combining the front-line chemotherapy with IV ascorbate. If there appears to be a benefit, a Phase II clinical trial is planned.

Marcus Foundation: Pharmacokinetic Evaluation of Intravenous Vitamin C

This research study will be conducted at the University of Kansas Medical Center with Jeanne Drisko, M.D. as the principal investigator.   Approximately 24 participants with cancer and approximately 42 healthy people will be enrolled and seen in the General Clinical Research Center at KU Medical Center. The goal of testing intravenous vitamin C is to achieve a desired good outcome at the smallest dose with minimal side effects.

Pharmacokinetic evaluation deals with the dose-concentration part. The pharmacokinetic processes of absorption, distribution, and elimination by the body determines how rapidly and for how long the drug will appear at the target location. Also, the relationship between a beneficial or toxic effect of a drug, and the safety of the drug needs to be established for different concentrations.

It is known that people with cancer are using high doses of intravenous vitamin C as a cancer treatment and this is occurring not infrequently. When vitamin C is given in this manner, it is known that it acts like a drug and not a vitamin. It is not known how high-doses of intravenous vitamin C are handled and eliminated by the body or if it is safe. This is in spite of the fact that high-dose intravenous vitamin C has been given to patients for over 30 years. No formal pharmacokinetic study has been done at these high doses.

Multiple doses of vitamin C will be given by vein in this study. The first dose level will be 25 grams, followed by 50 grams, then 75 grams, and finally 100 grams. Three to 6 people will be invited to participate in each of the dose levels and you will be asked to get a total of 4 doses at that level spread out over 4 weeks. In addition, you will have an initial visit and a follow-up visit both lasting 30 minutes. This will total 6 visits. Each of the 4 infusion visits will last 24 hours and the same procedure will be followed that is outlined above for visits 1 and 4 only (see the schedule attached to the end of the consent). On visits 2 and 3 you will not have blood collected over the entire 24 hours, but only have blood collected at the beginning and when the infusion is over. The total blood drawn for visits 2 and 3 will be approximately 2 tablespoons and will check your kidney and liver function. You will be asked to give 9 urine samples over the 24-hours. You will have an electrocardiogram at each of these visits.