Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Supportive care Closed 18 and over NCI MAYO-MC03C2 NCT00425906

Objectives

1. Determine whether patients with malignant bowel obstruction due to incurable cancer utilize a potential therapy for "hunger pain."
2. Determine, preliminarily, the efficacy and toxicity of nicotine in treating "hunger pain" in these patients.
3. Determine whether nicotine results in a decline in circulating ghrelin (for patients enrolled at the Mayo Rochester Clinic only).
4. Evaluate hormonal changes in patients treated with nicotine (for patients enrolled at the Mayo Rochester Clinic only).

Entry 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

Prior/Concurrent Therapy:

• Concurrent short-term use of dexamethasone or other hormonal therapy or symptom control strategy allowed

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

Expected Enrollment

A total of 20 patients will be accrued for this study.

Outcomes

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

Toxicity as measured by CTCAE v 2.0
Global quality of life
Hunger assessment
Change in circulating hormonal concentrations (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.

Trial Contact Information

Trial Lead Organizations

Mayo Clinic Cancer Center

Aminah Jatoi, MD, Protocol chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu
Gerardo Colon-Otero, MD, Protocol co-chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu
Lynn Hartmann, MD, Protocol co-chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu
Bobbie Gostout, MD, Protocol co-chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu
Richard Hurt, MD, Protocol co-chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu
Lorraine Fitzpatrick, MD, Protocol co-chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu
Tom Moyer, PhD, Protocol co-chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu

Registry Information
Official Title		A Pilot Study of Nicotine for "Hunger Pain" in Patients with Bowel Obstruction from Incurable Cancer
Trial Start Date		2003-12-15
Registered in ClinicalTrials.gov		NCT00425906
Date Submitted to PDQ		2006-11-30
Information Last Verified		2007-06-05
NCI Grant/Contract Number		CA15083