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Home > "S" Clinical Trials Conditions > Survey of the Use of Alternative Medical Therapies in Adult Cancer Patients Enrolled in Phase I Clinical Trials  Survey of the Use of Alternative Medical Therapies in Adult Cancer Patients Enrolled in Phase I Clinical Trials
Survey of the Use of Alternative Medical Therapies in Adult Cancer Patients Enrolled in Phase I Clinical Trials
For Condition: Neoplasm
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: Simultaneous use of alternative or complementary medical therapies by cancer patients undergoing conventional medical treatment is extremely common and may not always be disclosed to the patient's treating physician. Cancer patients undergoing Phase I therapy on clinical trials constitute a special population of patients, since by definition, their prescribed therapy is scientifically unproven in terms of efficacy. Phase I patients are closely monitored for adverse effects in order to identify and characterize the toxicities and to define a tolerable dose of their experimental treatment. Thus, the unrecognized use of alternative therapies by patients actively enrolled in phase I trials may potentially confound rational drug development by causing adverse side effects or by contributing to drug interactions. Examples of clinical toxicities induced by alternative medical treatments include liver dysfunction or renal failure caused by herbal preparations, or hematologic abnormalities, such as eosinophilia-myalgia syndrome caused by tryptophan food supplements. Therefore, it is important to document and determine the prevalence of alternative therapy use in this specific patient population; however, this issue has not previously been examined in a scientifically rigorous manner. We propose to conduct a survey and interview study of phase I cancer patients enrolled in ongoing clinical trials at the National Cancer Institute to determine the prevalence of alternative therapy use in this population. This study will also examine patient attitudes and perceptions regarding their use of alternative therapy as compared with their scientifically-sanctioned phase I experimental therapy. This information has important implications for drug development.
Details: Simultaneous use of alternative or complementary medical therapies by cancer patients undergoing conventional medical treatment is extremely common and may not always be disclosed to the patient's treating physician. Cancer patients undergoing Phase I therapy on clinical trials constitute a special population of patients, since by definition, their prescribed therapy is scientifically unproven in terms of efficacy. Phase I patients are closely monitored for adverse effects in order to identify and characterize the toxicities and to define a tolerable dose of their experimental treatment. Thus, the unrecognized use of alternative therapies by patients actively enrolled in phase I trials may potentially confound rational drug development by causing adverse side effects or by contributing to drug interactions. Examples of clinical toxicities induced by alternative medical treatments include liver dysfunction or renal failure caused by herbal preparations, or hematologic abnormalities, such as eosinophilia-myalgia syndrome caused by tryptophan food supplements. Therefore, it is important to document and determine the prevalence of alternative therapy use in this specific patient population; however, this issue has not previously been examined in a scientifically rigorous manner. We propose to conduct a survey and interview study of phase I cancer patients enrolled in ongoing clinical trials at the National Cancer Institute to determine the prevalence of alternative therapy use in this population. This study will also examine patient attitudes and perceptions regarding their use of alternative therapy as compared with their scientifically-sanctioned phase I experimental therapy. This information has important implications for drug development.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Patients must be registered and actively participating in a Phase I clinical trial in the Division of Hematology/Oncology, National Naval Medical Center. Patients must be able to give signed, informed consent. Patients must be greater than or equal to 18 years old. Patients must be medically well enough to be interviewed and to fill out the study questionnaire. Patients must not have been previously enrolled in this study.
Total Enrollment: 125
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 980098; 98-C-0098
Study Start Date: April 17, 1998
Record last reviewed: January 17, 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001695
Other Neoplasm Studies:
1. Collection of Blood, Bone Marrow, Tumor, or Tissue Samples from Patients with Cancer to Study Drug Resistance
2. A Phase I Trial of Daily Bolus Flavopiridol in Patients with Refractory Neoplasms
3. The Use of Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI) to Assess the Effects of Anti-Neoplastic Therapy on Tumor Associated Vasculature
4. Experimental Drug BMS-247550 to Treat Cancer
5. Continuing Care and Treatment for Patients with Cancer/AIDS/Skin Disease
Related Studies:
Other Neoplasm Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Survey of the Use of Alternative Medical Therapies in Adult Cancer Patients Enrolled in Phase I Clinical Trials
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