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

Not Applicable

Withdrawn

• Conditions: Anorexia; Unspecified Adult Solid Tumor, Protocol Specific; Pain; Constipation, Impaction, and Bowel Obstruction; Psychosocial Effects of Cancer and Its Treatment
• Interventions: Other: Placebo; Drug: nicotine; Procedure: Quality of life

• Registration Number: NCT00425906
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2007-01-19
• Study First Submitted QC: 2007-01-19
• Study First Posted: 2007-01-23
• Status Verified: 2011-07
• Last Update Submitted: 2016-01-11
• Last Update Posted: 2016-01-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Placebo inhaler	Placebo	-
Placebo inhaler	Quality of life	-
Nicotine inhaler	Quality of life	-
Nicotine inhaler	nicotine	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Toxicity as measured by CTCAE v 2.0	48 hours
Hunger assessment	48 hours
Change in circulating hormonal concentrations (for patients enrolled at the Mayo Rochester Clinic only)	48 hours
Global quality of life	48 hours