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

Mayo Clinic

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Conditions

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

Interventions

nicotineDRUG

PlaceboOTHER

Quality of lifePROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Determination of whether ≥ 50% of patients utilize nicotine for treating "hunger pain" ≥ 2 times over a 48-hour period

Time frame: 48 Hours

Secondary Outcomes

Toxicity as measured by CTCAE v 2.0

Time frame: 48 hours

Global quality of life

Time frame: 48 hours

Hunger assessment

Time frame: 48 hours

Change in circulating hormonal concentrations (for patients enrolled at the Mayo Rochester Clinic only)

Time frame: 48 hours

Data from ClinicalTrials.gov

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