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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00425906
• Other study ID #: CDR0000526182
• Secondary ID: P30CA015083MC03C
• Status: Withdrawn
• Phase: N/A
• First received: January 19, 2007
• Last updated: January 11, 2016
• Start date: December 2003

Study information

• Verified date: July 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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 Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anorexia
• Constipation
• Constipation, Impaction, and Bowel Obstruction
• Intestinal Obstruction
• Pain
• Psychosocial Effects of Cancer and Its Treatment
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• nicotine

Other:
• Placebo

Procedure:
• Quality of life

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of whether = 50% of patients utilize nicotine for treating "hunger pain" = 2 times over a 48-hour period		48 Hours	No
Secondary	Toxicity as measured by CTCAE v 2.0		48 hours	Yes
Secondary	Global quality of life		48 hours	No
Secondary	Hunger assessment		48 hours	No
Secondary	Change in circulating hormonal concentrations (for patients enrolled at the Mayo Rochester Clinic only)		48 hours	No