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

NCT00425906 | Withdrawn DMC

• 4 other identifiers: CDR0000526182P30CA015083MC03C21217-03
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• Determination of whether ≥ 50% of patients utilize nicotine for treating "hunger pain" ≥ 2 times over a 48-hour period

  48 Hours

Secondary Outcomes (4)

• Toxicity as measured by CTCAE v 2.0

  48 hours

• Global quality of life

  48 hours

• Hunger assessment

  48 hours

• Change in circulating hormonal concentrations (for patients enrolled at the Mayo Rochester Clinic only)

  48 hours

Study Arms (2)

Nicotine inhaler

EXPERIMENTAL

Drug: nicotine; Procedure: Quality of life

Placebo inhaler

PLACEBO COMPARATOR

Other: Placebo; Procedure: Quality of life

Interventions

nicotine DRUG

Nicotine inhaler

Placebo OTHER

Placebo inhaler

Quality of life PROCEDURE

Nicotine inhaler; Placebo inhaler

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Anorexia; Constipation; Intestinal Obstruction; Pain

Interventions

Nicotine; Quality of Life

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Aminah Jatoi, MD

  Mayo Clinic

  STUDY CHAIR

• Gerardo Colon-Otero, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 19, 2007
• First Posted: January 23, 2007
• Study Start: December 1, 2003
• Last Updated: January 12, 2016

Record last verified: 2011-07