Bupropion and intensive behavioral therapy in Cancer and Tobacco Abuse - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Cancer and Tobacco Abuse

Intervention / Treatment

Drug: Bupropion and intensive behavioral therapy

Detailed Description

There is overwhelming evidence to support tobacco use as the number one cause of preventable cancer and cardiovascular death. Smoking is responsible for at least 30% of all cancer deaths and nearly 90% of lung cancer deaths. There is robust phase III randomized data to show improved smoking cessation with both behavioral strategies as well as pharmacologic interventions such as bupropion.

Despite significant evidence showing survival, toxicity and quality of life detriments in cancer patients who continue smoking after diagnosis, roughly one third of cancer patients continue to use tobacco. There is a relative paucity of data regarding smoking cessation programs in cancer patient populations. Several single institution, as well as cooperative group (ECOG), efforts have been published with varying results. However, to date, there are no published reports on the success of pharmacologic smoking cessation interventions in cancer patients.

Patients undergoing definitive/curative radiotherapy often receive daily treatment over the course of three to eight weeks. They are often accompanied and supported daily by family members or companions, many of whom smoke. This represents a huge exposure to the health care system and a unique opportunity for intensive intervention in both cancer patients and their families/companions during their "daily routine" of radiotherapy. To date, there is no published report on intensive tobacco cessation intervention concurrent with radiotherapy in cancer patients and their families or companions.

We propose a feasibility study of an intensive tobacco cessation program to be delivered to radiation oncology patients and/or their family/companions concurrent with planned radiotherapy. This program will feature an intensive behavioral intervention as well as the pharmacologic agent bupropion.

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Indiana
  - Indianapolis, Indiana, United States, 46202
    - Indiana University, Department of Radiation Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Eligibility for Radiotherapy Patients
age 18 years or older
receiving three weeks or more of external beam radiotherapy
report smoking one or more cigarettes in the past 30 days or self-identify as a smoker
Cancer Stage:
Stage I-III
IVa Head and Neck Malignancy is allowed
Stage I-IV breast, prostate, testis or lymphoma also allowed
at least one year life expectancy
have given written informed consent
KPS 70-100

Eligibility for Family/Companions of Radiotherapy Patients (Note: Family members/companions are eligible for this protocol regardless of whether the index radiotherapy patient is eligible or willing to participate.)

age 18 years or older
at least one year life expectancy
radiotherapy patient is receiving three weeks or more of external beam radiotherapy
Person is committed to bringing/accompanying the patient to radiotherapy at least three days per week.
report smoking one or more cigarettes in the past 30 days or self-identify as a smoker
Family member/companion of patients under radiotherapy treatment for any stage of cancer
have given written informed consent
KPS 70-100

Exclusion Criteria:

Exclusion Criteria for both Radiotherapy Patients and their Families/Companions
serious or unstable cardiac, renal, hypertensive, pulmonary, endocrine, or neurologic disorders, as assessed by the study-site physician
a current diagnosis of major depressive episode or a history of panic disorder, psychosis, bipolar disorder, or eating disorders
pregnancy or lactation
any history of allergy/intolerance or adverse reaction to bupropion
history of seizure disorder, bulimia or anorexia nervosa
use of an MAOi within 14 days
current use of another antidepressant
abrupt discontinuation of alcohol or sedatives
unwilling/unable to meet with the behavioral interventionalist for 20 minutes, at least 3 days per week during the course of radiotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To test the feasibility of using the medication bupropion and behavioral therapy to help people stop smoking in the radiation oncology clinic. Time Frame: 1 year from enrollment	1 year from enrollment

Secondary Outcome Measures

Outcome Measure	Time Frame
Smoking cessation status will be formally assessed by patient report, and for those reporting tobacco abstinence, confirmed by carbon monoxide breath testing concentrations of 10 ppm or less. Time Frame: 1 year from enrollment	1 year from enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University School of Medicine

Collaborators

Walther Cancer Institute

Investigators

Principal Investigator: Anna McDaniel, DNS, RN, FAAN, Department of Environments for Health, Indiana University School of Nursing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

October 7, 2005

First Submitted That Met QC Criteria