Nicotine in Treating "Hunger Pain" in Patients With Malignant Bowel Obstruction Caused By Cancer - Full Text View

Sponsor:	Mayo Clinic
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00425906

Purpose

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.

Condition	Intervention
Anorexia Constipation, Impaction, and Bowel Obstruction Pain Psychosocial Effects of Cancer and Its Treatment Unspecified Adult Solid Tumor, Protocol Specific	Drug: nicotine Procedure: psychosocial assessment and care Procedure: quality-of-life assessment

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double-Blind, Placebo Control
Official Title:	A Pilot Study of Nicotine for "Hunger Pain" in Patients With Bowel Obstruction From Incurable Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Constipation Intestinal Obstruction

Drug Information available for: Nicotine tartrate Nicotine polacrilex

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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

Secondary Outcome 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)

Estimated Enrollment:	20
Study Start Date:	December 2003

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425906

Locations

United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

National Cancer Institute (NCI)

Investigators

Study Chair:	Aminah Jatoi, MD	Mayo Clinic
Investigator:	Gerardo Colon-Otero, MD	Mayo Clinic
Investigator:	Lynn C. Hartmann, MD	Mayo Clinic
Investigator:	Bobbie S. Gostout, MD	Mayo Clinic
Investigator:	Richard D. Hurt, MD	Mayo Clinic
Investigator:	Lorraine Fitzpatrick, MD	Mayo Clinic
Investigator:	Tom Moyer, PhD	Mayo Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000526182, MAYO-MC03C2
Study First Received:	January 19, 2007
Last Updated:	July 20, 2009
ClinicalTrials.gov Identifier:	NCT00425906 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

psychosocial effects of cancer and its treatment
unspecified adult solid tumor, protocol specific
constipation, impaction, and bowel obstruction
anorexia
pain

Additional relevant MeSH terms:

Nicotine polacrilex
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Agonists
Signs and Symptoms, Digestive
Gastrointestinal Diseases
Nicotinic Agonists
Physiological Effects of Drugs
Central Nervous System Stimulants
Cholinergic Agents
Intestinal Diseases
Pharmacologic Actions

Intestinal Obstruction
Signs and Symptoms
Digestive System Diseases
Nicotine
Autonomic Agents
Therapeutic Uses
Anorexia
Constipation
Ganglionic Stimulants
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010