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

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

Study Overview

• Status: Withdrawn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

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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

PRIOR CONCURRENT THERAPY:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Gerardo Colon-Otero, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: December 1, 2003

Study Registration Dates

• First Submitted: January 19, 2007
• First Submitted That Met QC Criteria: January 19, 2007
• First Posted (Estimate): January 23, 2007

Study Record Updates

• Last Update Posted (Estimate): January 12, 2016
• Last Update Submitted That Met QC Criteria: January 11, 2016
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: unspecified adult solid tumor, protocol specific; pain; psychosocial effects of cancer and its treatment; anorexia; constipation, impaction, and bowel obstruction
• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Intestinal Diseases; Anorexia; Constipation; Intestinal Obstruction; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: CDR0000526182; P30CA015083 (U.S. NIH Grant/Contract); MC03C2 (Other Identifier: Mayo Clinic Cancer Center); 1217-03 (Other Identifier: Mayo Clinic IRB)