Clinical trial NCT00425906: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: 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
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-01-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Determination of whether ≥ 50% of patients utilize nicotine for treating "hunger pain" ≥ 2 times over a 48-hour period
timeFrame: 48 Hours
Secondary outcomes:
measure: Toxicity as measured by CTCAE v 2.0
timeFrame: 48 hours
measure: Global quality of life
timeFrame: 48 hours
measure: Hunger assessment
timeFrame: 48 hours
measure: Change in circulating hormonal concentrations (for patients enrolled at the Mayo Rochester Clinic only)
timeFrame: 48 hours
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Aminah Jatoi, MD
role: STUDY_CHAIR
affiliation: Mayo Clinic
name: Gerardo Colon-Otero, MD
role: PRINCIPAL_INVESTIGATOR
References: