Nicotine in Treating "Hunger Pain" in Patients With Malignant Bowel Obstruction Caused By Cancer
Primary Purpose
Anorexia, Constipation, Impaction, and Bowel Obstruction, Pain
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
nicotine
Placebo
Quality of life
Sponsored by
About this trial
This is an interventional supportive care trial for Anorexia focused on measuring psychosocial effects of cancer and its treatment, unspecified adult solid tumor, protocol specific, constipation, impaction, and bowel obstruction, anorexia, pain
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of any incurable malignancy
- Presence of malignant bowel obstruction
Must be on strict "nothing per os" (NPO) status over the next 48 hours
- Ice chips allowed
- Acknowledges that "hunger pain" is a problem
PATIENT CHARACTERISTICS:
- Mentally competent
- No history of life-threatening arrhythmia
- No severe or worsening angina
- No accelerated hypertension
- No known hypersensitivity to nicotine
- Not pregnant or nursing
- Negative pregnancy test
PRIOR CONCURRENT THERAPY:
- Concurrent short-term use of dexamethasone or other hormonal therapy or symptom control strategy allowed
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Nicotine inhaler
Placebo inhaler
Arm Description
Outcomes
Primary Outcome Measures
Determination of whether ≥ 50% of patients utilize nicotine for treating "hunger pain" ≥ 2 times over a 48-hour period
Secondary Outcome Measures
Toxicity as measured by CTCAE v 2.0
Global quality of life
Hunger assessment
Change in circulating hormonal concentrations (for patients enrolled at the Mayo Rochester Clinic only)
Full Information
NCT ID
NCT00425906
First Posted
January 19, 2007
Last Updated
January 11, 2016
Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00425906
Brief Title
Nicotine in Treating "Hunger Pain" in Patients With Malignant Bowel Obstruction Caused By Cancer
Official Title
A Pilot Study of Nicotine for "Hunger Pain" in Patients With Bowel Obstruction From Incurable Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Withdrawn
Why Stopped
No patient enrollment occurred.
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
RATIONALE: The use of a nicotine inhaler may help decrease appetite and relieve "hunger pain" (an intense craving for food) in patients with malignant bowel obstruction caused by cancer.
PURPOSE: This randomized clinical trial is studying the side effects and how well a nicotine inhaler works in treating "hunger pain" in patients with malignant bowel obstruction caused by cancer.
Detailed Description
OBJECTIVES:
Determine whether patients with malignant bowel obstruction due to incurable cancer utilize a potential therapy for "hunger pain."
Determine, preliminarily, the efficacy and toxicity of nicotine in treating "hunger pain" in these patients.
Determine whether nicotine results in a decline in circulating ghrelin (for patients enrolled at the Mayo Rochester Clinic only).
Evaluate hormonal changes in patients treated with nicotine (for patients enrolled at the Mayo Rochester Clinic only).
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter, pilot study. Patients are stratified according to vomiting status within the past 24 hours (yes vs no) and use of narcotics (yes vs no). Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive a nicotine inhaler to use as needed for "hunger pain." Treatment continues for up to 48 hours in the absence of unacceptable toxicity .
Arm II: Patients receive a placebo inhaler to use as needed for "hunger pain." Treatment continues for up to 48 hours in the absence of unacceptable toxicity.
After 48 hours, patients in arm I may continue nicotine therapy off study. Patients in arm II who are not surgical candidates may cross over to treatment with the nicotine inhaler off study.
Blood and spot urine samples are collected at baseline and after 48 hours from patients enrolled at the Mayo Rochester Clinic. Blood samples are analyzed to evaluate circulating hormone (e.g., ghrelin, leptin) concentrations. Urine samples are analyzed to evaluate nicotine and nicotine metabolite concentrations.
Global quality of life is assessed at baseline and after 48 hours. "Hunger pain" is assessed at baseline.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia, Constipation, Impaction, and Bowel Obstruction, Pain, Psychosocial Effects of Cancer and Its Treatment, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
psychosocial effects of cancer and its treatment, unspecified adult solid tumor, protocol specific, constipation, impaction, and bowel obstruction, anorexia, pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nicotine inhaler
Arm Type
Experimental
Arm Title
Placebo inhaler
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
nicotine
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Type
Procedure
Intervention Name(s)
Quality of life
Primary Outcome Measure Information:
Title
Determination of whether ≥ 50% of patients utilize nicotine for treating "hunger pain" ≥ 2 times over a 48-hour period
Time Frame
48 Hours
Secondary Outcome Measure Information:
Title
Toxicity as measured by CTCAE v 2.0
Time Frame
48 hours
Title
Global quality of life
Time Frame
48 hours
Title
Hunger assessment
Time Frame
48 hours
Title
Change in circulating hormonal concentrations (for patients enrolled at the Mayo Rochester Clinic only)
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of any incurable malignancy
Presence of malignant bowel obstruction
Must be on strict "nothing per os" (NPO) status over the next 48 hours
Ice chips allowed
Acknowledges that "hunger pain" is a problem
PATIENT CHARACTERISTICS:
Mentally competent
No history of life-threatening arrhythmia
No severe or worsening angina
No accelerated hypertension
No known hypersensitivity to nicotine
Not pregnant or nursing
Negative pregnancy test
PRIOR CONCURRENT THERAPY:
Concurrent short-term use of dexamethasone or other hormonal therapy or symptom control strategy allowed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aminah Jatoi, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gerardo Colon-Otero, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Nicotine in Treating "Hunger Pain" in Patients With Malignant Bowel Obstruction Caused By Cancer
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