Trial Information

A Pilot Study of Nicotine for "Hunger Pain" in Patients With Bowel Obstruction From Incurable 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.