Official Title: “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 Type: Interventional

Study Design: Supportive Care, Randomized, Double-Blind, Placebo Control

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.

Intervention(s) in this Clinical Trial

• Drug: nicotine
• Procedure: psychosocial assessment and care
• Procedure: quality-of-life assessment

Primary Measures

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

Secondary Measures

• 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)

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Mayo Clinic

Overall Clinical Trial Officials and Contacts

Aminah Jatoi, MD Study Chair Mayo Clinic  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00425906

Study ID Number: CDR0000526182

ClinicalTrials.gov Identifier: NCT00425906

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database