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

This study has been withdrawn prior to enrollment.
(No patient enrollment occurred.)
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00425906
First received: January 19, 2007
Last updated: July 1, 2011
Last verified: July 2011
  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:


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
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
Fecal Impaction
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 April 17, 2014