Nicotine in Treating "Hunger Pain" in Patients With Malignant Bowel Obstruction Caused By Cancer
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.
Constipation, Impaction, and Bowel Obstruction
Psychosocial Effects of Cancer and Its Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Procedure: Quality of life
|Study Design:||Allocation: Randomized
Primary Purpose: Supportive Care
|Official Title:||A Pilot Study of Nicotine for "Hunger Pain" in Patients With Bowel Obstruction From Incurable Cancer|
- Determination of whether ≥ 50% of patients utilize nicotine for treating "hunger pain" ≥ 2 times over a 48-hour period [ Time Frame: 48 Hours ]
- 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 ]
|Study Start Date:||December 2003|
|Experimental: Nicotine inhaler||Drug: nicotine Procedure: Quality of life|
|Placebo Comparator: Placebo inhaler||Other: Placebo Procedure: Quality of life|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00425906
|Study Chair:||Aminah Jatoi, MD||Mayo Clinic|
|Principal Investigator:||Gerardo Colon-Otero, MD||Mayo Clinic|