[MOL] Alt. Treatments in Trials [01417] Medicine On Line


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[MOL] Alt. Treatments in Trials



 

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•The University of Texas Center for Alternative Medicine (UT-CAM) is one of
11 research centers established by the Office of Alternative Medicine at
the National Institutes of Health to evaluate alternative therapies. The
University of Texas Center is the only OAM supported institution focused
solely on alternative and complementary treatments for cancer. •During Year
1, our primary aims were to evaluate the science for
biopharmacologic/herbal/natural therapies in a systematic fashion, develop
a network of AM practitioners/researchers for collaborative research, and
establish a research agenda. We assessed the state of the science for some
30 widely used, potentially promising CAM therapies, built a network of CAM
and conventional practitioners, and established a research agenda. •During
Year 2, our primary goal was to develop protocols and facilitate research.
We completed a pilot survey on use and attitudes of CAM therapies and
finalized protocols. •The goals for this Year 3, currently in progress, are
to continue to develop and implement protocols, submit proposals to funding
agencies and foundations, and update and expand the state of the science
reviews. •We hope to assist you in thinking critically about your options.
Information is critical, not only for you, but also for your treating
physician. In the event you choose a treatment that is outside mainstream
medical practice, we encourage you to inform your primary physician(s) and
oncologist. 


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Current Projects

CLINICAL:



•Melatonin: A randomized Phase III study is underway to 1) determine if 20
mg of melatonin, in a continuous daily administration, decreases the
hematopoetic toxicity of CHOP in patients with large cell lymphoma of
favorable risk, and 2) determine response rate, disease free survival, and
survival of patients treated with CHOP and melatonin. •Mistletoe: A pilot
study is currently underway to assess the feasibility of recruiting and
administering Helixor A mistletoe (Viscum album L) to patients who have
advanced, unresectable, or recurrent esophagus cancer and are candidates
for palliative treatment. The study will document quality of life and
clinical benefit associated with mistletoe treatment. •Flor· Essence Herbal
Tonic: A clinical protocol is being finalized for a pilot study that will
1) determine the feasibility of accrual and compliance of Stage IV
colorectal cancer patients post chemotherapy to a clinical trial using the
herbal extract Flor· Essence, 2) document safety and tolerability of
Flor-Essence, 3) determine quality of life associated with Flor· Essence,
and 4) determine the impact of Flor· Essence on clinical outcomes (eg,
pain, weight, and number and function of T lymphocytes). •714-X: A
prospective outcome monitoring evaluation system (POMES) for 714-X is under
development to 1) monitor the safety of chronic daily administration of
714-X among 5 patients who have pathologically confirmed cancer and have
either failed or refused conventional therapy, 2) assess the effect of
714-X on quality of life and performance status, and 3) document the effect
of 714-X on biological markers, disease progression, and survival. 



ANIMAL STUDIES:



•Ginseng: Two protocols were designed to determine if Korean Red Ginseng
saponins can 1) modulate carcinogenic metabolism and 2) impact the
progression of established and developing precancerous lesions in the rat
colon. In Protocol 1, ginseng significantly modulated aberrant crypt foci
in the low dose group (0.1 g/kg), amounting to a 25% suppression compared
with carcinogen only controls; however, we did not find suppression at the
higher dose (1g/kg). Results of Protocol 2 suggest no protective effect of
ginseng on developing lesions. We are preparing to replicate Protocol 1.
•Shark Cartilage: A series of in-vivo experiments with frozen liquid shark
cartilage extract will start in September to determine the optimum dose and
timing of the cartilage intervention after tumor inoculation using prostate
specific antigen (PSA) and growth kinetics of the prostate tumor in Phase
I. Phase II will determine the impact of optimal dose and time on 1)
survival 2) clinical outcomes of PSA and vascular endothelial growth factor
(VEGF), and 3) microvascular density of the tumor volume.




LABORATORY STUDIES:




•Coenzyme Q10 (Ubiquinone): We are co-administering Coenzyme Q10 (CoQ10)
with standard anticancer drugs for breast cancer to 1) assess the relative
toxicity of (CoQ10) in a human breast cancer cell line (MCF7), and 2)
assess whether the agent interferes with or augments the cytotoxicity of
standard chemotherapeutic agents (ie, Adriamycin, Paclitaxel, Cisplatin,
and Taxol) and the new anticancer drugs, proteasome inhibitors. The second
phase testing the effect of CoQ10 on the impact of Adriamycin apoptosis
mediated pathway is pending. •Green Tea: To test the impact of green tea on
mutagen-induced damage, a Poisson regression model (Stata 5.0) used the
number of chromatid breaks as the dependent variable and green tea, the
mutagen, and the interaction of green tea and mutagen as predictor
variables. The analysis of the antioxidant properties of green tea has been
completed, and a manuscript is in preparation. The findings suggest that
green tea may be associated with decreased genetic damage as cells treated
with green tea tended to have fewer chromatid breaks than untreated cells.
•Anticancer Agents from Marine Sourse (Seacucumber): A series of
experiments are currently underway to 1) isolate and purify the active
ingredient of the marine animal and 2) evaluate the effectiveness of the
natural agent to block an enzyme that accelerates cancer progression in
animal models. 



SURVEYS & EPIDEMIOLOGIC RESEARCH:



•Survey of Use & Attitudes of Complementary/Alternative Medicine: Data
analysis is currently underway for a survey at U.T. M.D. Anderson Cancer
Center clinics to assess the prevalence of use, attitudes, and disclosure
to physicians of use of alternative/complementary therapies by cancer
patients. •Flor· Essence (Essiac): A pattern of use survey of the widely
used Flor· Essence: is currently underway. Based on the pattern of use
survey, we will identify cancer patients and survivors and invite them to
participate in a second survey to learn more about their experience with
the product. •Coley Toxins: The survival experience of patients with
cancers of the breast, ovarian, kidney, and soft tissues who received the
Coley toxins has been compared with patient records of the Surveillance
Endpoint Epidemiologic Results (SEER). The Cox Proportional Hazard model
with time dependent covariates controlled for the lapse time from diagnosis
to treatment with the Coley toxins and tested for the significance of
covariates to assess the survival experience. Results suggest that risk of
death was not significantly higher for Coley patients for any of the cancer
sites. •Hoxsey & Livingston Cancer Therapies: Two historical cohort studies
comparing the survival experience of patients treated during 1992 at these
two established alternative/complementary clinics are in progress. Reviews
of the Social Security Death Index to determine survival status of cancer
patients treated at both clinics are complete and follow-up to confirm
survival status is underway. •Vitamin C: In a closed workshop with 10
carefully selected experts, we will 1) critically assess the scientific
evidence of vitamin C as a cancer treatment and possible modes of action,
2) identify a limited set of clinical research questions to be answered,
and 3) design the most rigorous, scientific clinical trial design to test
high dose vitamin C, including appropriate cancer population,
inclusion/exclusion criteria, and biological outcomes.



NOTE: Information on clinical trials at MD Anderson Cancer Center can be
found by clicking the MDACC icon on this website or at
"www.mdanderson.org". 


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Credits
Please send comments and suggestions to UTCAM 


URL: http://www.sph.uth.tmc.edu/utcam/resact.htm 
last revision on August 10, 1998 
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