Ignite Creation Date:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2025-12-26 @ 5:24 PM
Study NCT ID:
NCT00425906
Status:
WITHDRAWN
Last Update Posted:
2016-01-12
First Post:
2007-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nicotine in Treating "Hunger Pain" in Patients With Malignant Bowel Obstruction Caused By Cancer
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
A Pilot Study of Nicotine for "Hunger Pain" in Patients With Bowel Obstruction From Incurable Cancer
Status:
WITHDRAWN
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No patient enrollment occurred.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
* 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA015083 | NIH | None | https://reporter.nih.gov/quic… | View |
| MC03C2 | OTHER | Mayo Clinic Cancer Center | View | |
| 1217-03 | OTHER | Mayo Clinic IRB | View |