Nicotine in Treating "Hunger Pain" in Patients With Malignant Bowel Obstruction Caused By Cancer
NCT ID: NCT00425906
Last Updated: 2016-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
NA
INTERVENTIONAL
2003-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Nabilone Effect on the Attenuation of Anorexia, Nutritional Status and Quality of Life in Lung Cancer Patients
NCT02802540
Fasting-mimicking Diet With Chemo-immunotherapy in Non-small Cell Lung Cancer (NSCLC)
NCT03700437
Placebo Controlled, Randomized Safety and Efficacy Study of RC-1291 in Cancer Anorexia/Cachexia.
NCT00267358
Study to Compare the Effects of Repeated Doses of an Investigational New Drug and a Placebo on Appetite in Advanced Cancer and Anorexia
NCT04803305
Enteral Nutrition With L-Carnitine for Cachexia in Non-Small Cell Lung Cancer
NCT07035444
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SUPPORTIVE_CARE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Nicotine inhaler
nicotine
Quality of life
Placebo inhaler
Placebo
Quality of life
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
nicotine
Placebo
Quality of life
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
120 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Mayo Clinic
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mayo Clinic
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Aminah Jatoi, MD
Role: STUDY_CHAIR
Mayo Clinic
Gerardo Colon-Otero, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MC03C2
Identifier Type: OTHER
Identifier Source: secondary_id
1217-03
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000526182
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.