AnorexiaNCT00425906
Nicotine in Treating "Hunger Pain" in Patients With Malignant Bowel Obstruction Caused By Cancer
A study testing nicotine and Quality of life in people with Anorexia and Constipation, Impaction, and Bowel Obstruction, run by Mayo Clinic.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Anorexia, Constipation, Impaction, and Bowel Obstruction, Pain
- What is being tested?
- nicotine and Quality of life
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2003to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
About this study
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.
Read the 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.
- Conditions
- Anorexia, Constipation, Impaction, and Bowel Obstruction, Pain, Psychosocial Effects of Cancer and Its Treatment, Unspecified Adult Solid Tumor, Protocol Specific
- Being tested
- nicotine, Placebo, Quality of life
- Keywords
- psychosocial effects of cancer and its treatment, unspecified adult solid tumor, protocol specific, constipation, impaction, and bowel obstruction, anorexia, pain
- Medical subject headings
- Anorexia, Constipation, Intestinal Obstruction, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nicotineDrug
PlaceboOther
Quality of lifeProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Nicotine inhaler | Experimental | Not described Receives: Drug: nicotine; Procedure: Quality of life |
| Placebo inhaler | Placebo comparator | Not described Receives: Other: Placebo; Procedure: Quality of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of whether ≥ 50% of patients utilize nicotine for treating "hunger pain" ≥ 2 times over a 48-hour period
Measured: 48 Hours
Secondary outcomes (4)
Toxicity as measured by CTCAE v 2.0
Measured: 48 hours
Global quality of life
Measured: 48 hours
Hunger assessment
Measured: 48 hours
Change in circulating hormonal concentrations (for patients enrolled at the Mayo Rochester Clinic only)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2007 (estimated)
- Study startDec 2003
Why it stopped: No patient enrollment occurred.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnorexiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Aminah Jatoi, MD, Study chair, Mayo ClinicGerardo Colon-Otero, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00425906
- Sponsor's protocol ID
- CDR0000526182
- Other IDs
- P30CA015083, MC03C2, 1217-03
- Status last verified
- Jul 2011
- First submitted
- 19 Jan 2007
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Nicotine for "Hunger Pain" in Patients With Bowel Obstruction From Incurable Cancer
- ClinicalTrials.gov ID
- NCT00425906
- Acronym / sponsor ID
- CDR0000526182
- 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
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patient enrollment occurred.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2003
- First posted
- 23 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicotine inhaler | Experimental | Drug: nicotine, Procedure: Quality of life |
| Placebo inhaler | Placebo comparator | Other: Placebo, Procedure: Quality of life |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nicotine | Drug | Nicotine inhaler |
| Placebo | Other | Placebo inhaler |
| Quality of life | Procedure or surgery | Nicotine inhaler, Placebo inhaler |
Primary outcome
Determination of whether ≥ 50% of patients utilize nicotine for treating "hunger pain" ≥ 2 times over a 48-hour period
Time frame: 48 Hours
4 secondary outcomes
Toxicity as measured by CTCAE v 2.0
Time frame: 48 hours
Global quality of life
Time frame: 48 hours
Hunger assessment
Time frame: 48 hours
Change in circulating hormonal concentrations (for patients enrolled at the Mayo Rochester Clinic only)
Time frame: 48 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aminah Jatoi, MD study chair
Mayo Clinic
Gerardo Colon-Otero, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A study testing nicotine and Quality of life in people with Anorexia and Constipation, Impaction, and Bowel Obstruction, run by Mayo Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of whether ≥ 50% of patients utilize nicotine for treating "hunger pain" ≥ 2 times over a 48-hour period (time frame: 48 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2016.