Anorexia, Constipation, Impaction, and Bowel Obstruction, Pain, Psychosocial Effects of Cancer and Its Treatment, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
psychosocial effects of cancer and its treatment, unspecified adult solid tumor, protocol specific, constipation, impaction, and bowel obstruction, anorexia, pain
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.
Interventions
DRUGnicotine
OTHERPlacebo
PROCEDUREQuality of life
Sponsors
National Cancer Institute (NCI)
Mayo Clinic
Study design
Allocation
RANDOMIZED
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of whether ≥ 50% of patients utilize nicotine for treating hunger pain ≥ 2 times over a 48-hour period | 48 Hours |
Secondary
| Measure | 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 |
Outcome results
None listed