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Survey of the Use of Alternative Medical Therapies in Adult Cancer Patients Enrolled in Phase I Clinical Trials


N/A
N/A
N/A
Not Enrolling
Both
Neoplasm

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Trial Information

Survey of the Use of Alternative Medical Therapies in Adult Cancer Patients Enrolled in Phase I Clinical Trials


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.

Inclusion 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.

Type of Study:

Observational

Study Design:

N/A

Authority:

United States: Federal Government

Study ID:

980098

NCT ID:

NCT00001695

Start Date:

April 1998

Completion Date:

January 2002

Related Keywords:

  • Neoplasm
  • Complementary Medicine
  • Unproven Treatments
  • Herbal
  • Neoplasms

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892