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

Mayo Clinic

Status: Withdrawn

Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Anorexia; Constipation, Impaction, and Bowel Obstruction; Psychosocial Effects of Cancer and Its Treatment; Pain

Treatments: Procedure: Quality of life; Drug: nicotine; Other: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00425906

P30CA015083 (U.S. NIH Grant/Contract)

1217-03 (Other Identifier)

CDR0000526182

MC03C2 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

0 participants in 2 patient groups, including a placebo group

Nicotine inhaler

Experimental group

Treatment:

Drug: nicotine

Procedure: Quality of life

Placebo inhaler

Placebo Comparator group

Treatment:

Procedure: Quality of life

Other: Placebo