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:	Mayo Clinic
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 Other: Placebo Procedure: Quality of life

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Double-Blind Primary Purpose: Supportive Care
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 Mayo Clinic:

Primary Outcome Measures:

Determination of whether ≥ 50% of patients utilize nicotine for treating "hunger pain" ≥ 2 times over a 48-hour period [ Time Frame: 48 Hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity as measured by CTCAE v 2.0 [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
Global quality of life [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Hunger assessment [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Change in circulating hormonal concentrations (for patients enrolled at the Mayo Rochester Clinic only) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	December 2003

Arms	Assigned Interventions
Experimental: Nicotine inhaler	Drug: nicotine Procedure: Quality of life
Placebo Comparator: Placebo inhaler	Other: Placebo 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.

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

Sponsors and Collaborators

Mayo Clinic

National Cancer Institute (NCI)

Investigators

Study Chair:	Aminah Jatoi, MD	Mayo Clinic
Principal Investigator:	Gerardo Colon-Otero, MD	Mayo Clinic in Florida

More Information

No publications provided

Responsible Party:	Aminah Jatoi, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00425906 History of Changes
Other Study ID Numbers:	CDR0000526182, P30CA015083, MC03C2, 1217-03
Study First Received:	January 19, 2007
Last Updated:	July 1, 2011
Health Authority:	United States: Federal Government

Keywords provided by Mayo Clinic:

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

Additional relevant MeSH terms:

Anorexia
Constipation
Intestinal Obstruction
Signs and Symptoms, Digestive
Signs and Symptoms
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012