Pine Street Foundation Clinical Trials Locator & Research News

HIFU (HIGH INTENSITY FOCUSED ULTRASOUND GUIDED BY MRI) FOR BREAST CANCER

STUDY RATIONALE: Imaging procedures, such as MRI, may allow better detection of breast cancer than mammogram. A new technique called High Intensity Focused Ultrasound (HIFU) may be able to kill tumor cells by heating the breast tumor cells without affecting the surrounding tissue.
RECRUITING: Men or women with biopsy-confirmed stages I, II, or IIIa invasive breast cancer, with one lesion no greater than 3.5 cm in diameter by MRI.
CONTACT: Mayo Clinic Cancer Center, Rochester, Minnesota, Kathy R. Brandt, (507) 284-2804; Centre Hospitalier de l'Universite de Montreal, Quebec, David Gianfelice, MD, (514) 891-8000 ext. 35619.
COMMENT: The Pine Street Foundation began reporting on HIFU in 2002 after we attended a conference on this technology in Seattle. We've been actively following the work of various international HIFU research groups (including the one at Oxford, England) and recently made a site visit to a HIFU program at the People's Hospital in Beijing in August 2003 (see Avenues 4).
This HIFU technology was first developed in China and the Mayo Clinic protocol is the first HIFU breast cancer trial outside of China.

HIFU FOR PROSTATE CANCER

STUDY RATIONALE: High Intensity Focused Ultrasound (HIFU) may be able to kill tumor cells by heating the prostate tumor cells without affecting the surrounding tissue.
RECRUITING: Men with biopsy-confirmed locally recurrent prostate cancer after prior surgery or external-beam radiation, who had an initial diagnosis of organ-confined disease (clinical stage T1 or T2 only). Gleason score no greater than 7, and PSA levels between 0.5 and 10.0.
CONTACT: Indiana University Cancer Center, Michael O. Koch, MD, (317) 630-6044.
COMMENT: This HIFU technology for prostate cancer was first developed in France.

LYMPHEDEMA AFTER BREAST CANCER SURGERY: PYCNOGENOL

STUDY RATIONALE: To investigate whether pycnogenol can improve healing of lymphedema.
RECRUITING: Women with lymphedema in one arm, at least two months after breast cancer surgery, and at least two months after chemotherapy or radiation.
CONTACT: Paul Hutson, Pharm.D., University of Wisconsin, (608) 263-2496, prhutson@pharmacy.wisc.edu.
COMMENT: The best results with lymphedema are obtained by starting treatment as early as possible. This trial design could be improved by adding a third treatment group that would examine the effectiveness of manual lymph drainage, a specialized massage technique originally developed in Switzerland, in treating lymphedema.

METASTATIC BREAST CANCER: DOCETAXEL & GARLIC

STUDY RATIONALE: Garlic stimulates liver metabolism. Taking garlic extract (600 mg, twice daily) during weekly docetaxel chemotherapy may also speed the metabolism of docetaxel, possibly reducing effectiveness of the drug.
RECRUITING: Women with metastatic breast cancer, at least three weeks after chemotherapy, and at least two weeks after hormonal therapy.
CONTACT: National Cancer Institute (NCI), (800) 411-1222, prpl@mail.cc.nih.gov.
COMMENT: Pine Street Foundation has long been focusing attention on what supplements should or should not be used at the same time as chemotherapy. As garlic is one of the most widely used supplements in the United States, it is of crucial public health importance to evaluate whether it may interfere with chemotherapy if both are circulating through the body at the same time.

DIABETES AND INSULIN RESISTANCE SYNDROME (SYNDROME X): GINKGO BILOBA

STUDY RATIONALE: Ginkgo biloba stimulates pancreatic beta-cell function in diabetes mellitus. It may also change the way the liver metabolizes diabetic medications.
RECRUITING: People with type 2 diabetes mellitus, age 20 to 75, who are taking oral diabetes medications - Glucotrol, Glucophage and Actose or Avandia.
CONTACT: George B. Kudolo, PhD, University of Texas, (210) 567-8866, kudolo@uthscsa.edu.
COMMENT: Insulin resistance syndrome is associated with the rise in obesity in the United States and may result from the over-emphasis on carbohydrates in the diet for the past two decades. This is an important trial that may show benefit with a relatively simple approach. As ginko is one of the most widely used supplements in the United States, it is of crucial public health importance to evaluate whether it actually works, especially in the context of diabetes and insulin resistance syndrome.

GREEN TEA IN PREVENTING PROSTATE CANCER: DOSAGE COUNTS

A well-designed study from China was published in January 2004 in the International Journal of Cancer, showing that green tea was clearly and strongly protective against developing prostate cancer. What is important about this study is that the authors were very specific in their assessment of quantity of tea consumed, which makes the results of this research straightforward to implement. Compared to those who did not drink green tea, subjects who were regular green tea drinkers lowered their risk of developing prostate cancer by 72%; subjects who drank green tea for over 40 years lowered their risk by 88%; consuming more than 1.5 kilograms of dried tea leaves per year lowered risk by 91%. While 1.5 kg of dried tea leaves appears to be a large quantity, it translates to approximately just one tablespoon of green tea leaves per day. Limitations of the study are that control subjects, used for comparison, were recruited in hospitals. This type of study design, called a case-control study, compares cases that are usually recruited from a hospital, to controls who do not have the disease in question. When controls are also recruited from a hospital, they are likely to be different in many ways from the general population, thus possibly biasing the results compared to what might have been found if control subjects had been recruited from the general population. In addition, the study was conducted in China, which has one of the world's lowest rates of prostate cancer. This means that the protection gained from drinking green tea may not be as strong in Western countries, where prostate cancer rates are much higher. Nevertheless, this study is a good example of how research can focus on ordinary food items that meet the definition of "could help, probably can't hurt."

SOURCE: Protective effect of green tea against prostate cancer: a case-control study in southeast China. Jian L, Xie LP, Lee AH, Binns CW. School of Public Health, Curtin University of Technology, Perth, WA, Australia. Int J Cancer. 2004 Jan 1;108(1):130-5.

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