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

Sponsor

Mayo Clinic (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00425906

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anorexia Constipation, Impaction, and Bowel Obstruction Pain Psychosocial Effects of Cancer and Its Treatment Unspecified Adult Solid Tumor, Protocol Specific	Drug: nicotine Other: Placebo Procedure: Quality of life	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Masking:

Double

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Dec 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nicotine inhaler	Drug: nicotine Procedure: Quality of life
Placebo Comparator: Placebo inhaler	Other: Placebo Procedure: Quality of life

Arm

Intervention/Treatment

Experimental: Nicotine inhaler

Drug: nicotine

Procedure: Quality of life

Placebo Comparator: Placebo inhaler

Other: Placebo

Procedure: Quality of life

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]