Nicotine in Treating Hunger Pain in Patients With Malignant Bowel Obstruction Caused By Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Study of Nicotine for Hunger Pain in Patients With Bowel Obstruction From Incurable Cancer

Conditions
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Pain, Anorexia, Constipation, Impaction, and Bowel Obstruction, Psychosocial Effects of Cancer and Its Treatment, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: nicotine
* Other: Placebo
* Procedure: Quality of life


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nicotine inhaler<br> | Drug: nicotine<br> <br> Procedure: Quality of life<br> <br> |
| Placebo Comparator: Placebo inhaler<br> | Other: Placebo<br> <br> Procedure: Quality of life<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of whether ≥ 50% of patients utilize nicotine for treating hunger pain ≥ 2 times over a 48-hour period |  | 48 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity as measured by CTCAE v 2.0 |  | 48 hours | 
| Global quality of life |  | 48 hours | 
| Hunger assessment |  | 48 hours | 
| Change in circulating hormonal concentrations (for patients enrolled at the Mayo Rochester Clinic only) |  | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychosocial effects of cancer and its treatment, unspecified adult solid tumor, protocol specific, constipation, impaction, and bowel obstruction, anorexia, pain