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

Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001695
• Other study ID #: 980098
• Secondary ID: 98-C-0098
• Status: Completed
• Phase: N/A
• First received: November 3, 1999
• Last updated: March 3, 2008
• Start date: April 1998
• Est. completion date: January 2002

Study information

• Verified date: January 2002
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: January 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Neoplasm

Locations

Country	Name	City	State
United States	National Cancer Institute (NCI)	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Cassileth BR, Chapman CC. Alternative and complementary cancer therapies. Cancer. 1996 Mar 15;77(6):1026-34. Review. — View Citation

Eisenberg DM, Kessler RC, Foster C, Norlock FE, Calkins DR, Delbanco TL. Unconventional medicine in the United States. Prevalence, costs, and patterns of use. N Engl J Med. 1993 Jan 28;328(4):246-52. — View Citation