Pain Clinical Trial
Official title:
A Pilot Study of Nicotine for "Hunger Pain" in Patients With Bowel Obstruction From Incurable Cancer
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.
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.
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05559255 -
Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI
|
N/A | |
| Completed |
NCT04748367 -
Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care
|
N/A | |
| Terminated |
NCT04356352 -
Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain
|
Phase 2/Phase 3 | |
| Completed |
NCT05057988 -
Virtual Empowered Relief for Chronic Pain
|
N/A | |
| Completed |
NCT04466111 -
Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
|
||
| Recruiting |
NCT05868122 -
A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy
|
Phase 3 | |
| Recruiting |
NCT06206252 -
Can Medical Cannabis Affect Opioid Use?
|
||
| Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
| Completed |
NCT03273114 -
Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain
|
N/A | |
| Enrolling by invitation |
NCT06087432 -
Is PNF Application Effective on Temporomandibular Dysfunction
|
N/A | |
| Completed |
NCT05508594 -
Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001
|
Phase 2/Phase 3 | |
| Recruiting |
NCT03646955 -
Partial Breast Versus no Irradiation for Women With Early Breast Cancer
|
N/A | |
| Active, not recruiting |
NCT03472300 -
Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
|
||
| Completed |
NCT03678168 -
A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries
|
N/A | |
| Completed |
NCT03286543 -
Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System
|
N/A | |
| Completed |
NCT03931772 -
Online Automated Self-Hypnosis Program
|
N/A | |
| Completed |
NCT02913027 -
Can We Improve the Comfort of Pelvic Exams?
|
N/A | |
| Terminated |
NCT02181387 -
Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor?
|
Phase 4 | |
| Recruiting |
NCT06032559 -
Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment
|
Phase 3 | |
| Active, not recruiting |
NCT03613155 -
Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care
|