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

Primary Purpose

Anorexia, Constipation, Impaction, and Bowel Obstruction, Pain

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
nicotine
Placebo
Quality of life
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anorexia focused on measuring psychosocial effects of cancer and its treatment, unspecified adult solid tumor, protocol specific, constipation, impaction, and bowel obstruction, anorexia, pain

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Nicotine inhaler

    Placebo inhaler

    Arm Description

    Outcomes

    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)

    Full Information

    First Posted
    January 19, 2007
    Last Updated
    January 11, 2016
    Sponsor
    Mayo Clinic
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00425906
    Brief Title
    Nicotine in Treating "Hunger Pain" in Patients With Malignant Bowel Obstruction Caused By Cancer
    Official Title
    A Pilot Study of Nicotine for "Hunger Pain" in Patients With Bowel Obstruction From Incurable Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2011
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No patient enrollment occurred.
    Study Start Date
    December 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Mayo Clinic
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anorexia, Constipation, Impaction, and Bowel Obstruction, Pain, Psychosocial Effects of Cancer and Its Treatment, Unspecified Adult Solid Tumor, Protocol Specific
    Keywords
    psychosocial effects of cancer and its treatment, unspecified adult solid tumor, protocol specific, constipation, impaction, and bowel obstruction, anorexia, pain

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Nicotine inhaler
    Arm Type
    Experimental
    Arm Title
    Placebo inhaler
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    nicotine
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Type
    Procedure
    Intervention Name(s)
    Quality of life
    Primary Outcome Measure Information:
    Title
    Determination of whether ≥ 50% of patients utilize nicotine for treating "hunger pain" ≥ 2 times over a 48-hour period
    Time Frame
    48 Hours
    Secondary Outcome Measure Information:
    Title
    Toxicity as measured by CTCAE v 2.0
    Time Frame
    48 hours
    Title
    Global quality of life
    Time Frame
    48 hours
    Title
    Hunger assessment
    Time Frame
    48 hours
    Title
    Change in circulating hormonal concentrations (for patients enrolled at the Mayo Rochester Clinic only)
    Time Frame
    48 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    120 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Aminah Jatoi, MD
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Gerardo Colon-Otero, MD
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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