FatigueNCT00176540
Dextromethorphan in Treating Patients With Fatigue Caused by Cancer
A study testing dextromethorphan hydrobromide in people with Fatigue and Unspecified Adult Solid Tumor, Protocol Specific, run by University of Medicine and Dentistry of New Jersey at 2 sites in United States.
Trial summary
RATIONALE: Dextromethorphan may help relieve fatigue in patients with cancer. PURPOSE: This clinical trial is studying how well dextromethorphan works in treating patients with fatigue caused by cancer. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Fatigue, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
- What is being tested?
- dextromethorphan hydrobromide
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2003to Aug 2007
- 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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of malignancy
- Must be undergoing active treatment for malignancy which may include hormonal therapy (e.g., tamoxifen citrate or leuprolide acetate), but not radiotherapy alone
- Fatigue score ≥ 4 on a verbal analogue scale of 0 to 10
- No untreated cancer-related anemia
PATIENT CHARACTERISTICS:
- Hemoglobin > 10 g/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able to swallow pills
- No known allergy to dextromethorphan hydrobromide
- No patients known to be phenotypically poor metabolizers of CYP2D6
- No untreated hypothyroidism
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Prior single-dose inhibitors (e.g., ranitidine or cimetidine) for hypersensitivity prophylaxis allowed
- Erythropoietic growth factor therapy of > 8 weeks duration allowed
- No concurrent CYP2D6 inducers or inhibitors
- No concurrent monoamine oxidase inhibitors
- No other concurrent medications containing dextromethorphan hydrobromide
- No concurrent over-the-counter medication, herbal product, vitamin, food supplement, or any other type of special product unless permission to continue use is obtained from the Principal Investigator
- No other concurrent anticancer investigational agents or therapies
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, 08690
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
About this study
Official title: A Pilot Trial to Evaluate the Effects of Dextromethorphan in Patients Suffering From Cancer-Related Fatigue
RATIONALE: Dextromethorphan may help relieve fatigue in patients with cancer.
PURPOSE: This clinical trial is studying how well dextromethorphan works in treating patients with fatigue caused by cancer.
Read the detailed description
OBJECTIVES:
Primary
- Assess the effects of dextromethorphan hydrobromide in patients with cancer-related fatigue.
Secondary
- Correlate the changes in cancer-related fatigue with the levels of plasma homocysteine versus red blood cell folate.
OUTLINE: This is a multicenter, open-label, pilot study.
Patients receive oral dextromethorphan hydrobromide 3 times a day on days 1-7. Treatment repeats weekly for up to 3 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
- Conditions
- Fatigue, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
- Being tested
- dextromethorphan hydrobromide
- Keywords
- unspecified adult solid tumor, protocol specific, unspecified childhood solid tumor, protocol specific, fatigue
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dextromethorphan hydrobromideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Secondary outcomes (1)
Correlation of the changes in cancer-related fatigue with the levels of plasma homocysteine versus red blood cell folate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startOct 2003
- Primary completionAug 2007
- Study completionAug 2007
Why it stopped: slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Susan Goodin, PharmD, FCCP, BCOP, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00176540
- Sponsor's protocol ID
- CDR0000539650
- Other IDs
- P30CA072720, CINJ-5017v2, CINJ-4598, CINJ-NJ11005
- Status last verified
- May 2011
- First submitted
- 12 Sep 2005
- Last updated
- 17 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial to Evaluate the Effects of Dextromethorphan in Patients Suffering From Cancer-Related Fatigue
- ClinicalTrials.gov ID
- NCT00176540
- Acronym / sponsor ID
- CDR0000539650
- Conditions
- Fatigue, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
- Keywords
- unspecified adult solid tumor, protocol specific, unspecified childhood solid tumor, protocol specific, fatigue
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow accrual
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Medicine and Dentistry of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2003
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 15 Sep 2005 (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: Dextromethorphan may help relieve fatigue in patients with cancer.
PURPOSE: This clinical trial is studying how well dextromethorphan works in treating patients with fatigue caused by cancer.
Detailed description
OBJECTIVES:
Primary
- Assess the effects of dextromethorphan hydrobromide in patients with cancer-related fatigue.
Secondary
- Correlate the changes in cancer-related fatigue with the levels of plasma homocysteine versus red blood cell folate.
OUTLINE: This is a multicenter, open-label, pilot study.
Patients receive oral dextromethorphan hydrobromide 3 times a day on days 1-7. Treatment repeats weekly for up to 3 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Study design
- Primary purpose
- Supportive care
- Masking
- None (open label)
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| dextromethorphan hydrobromide | Drug | – |
Primary outcome
Efficacy
1 secondary outcome
Correlation of the changes in cancer-related fatigue with the levels of plasma homocysteine versus red blood cell folate
Results and safety
The study was stopped early (reason given: slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2011.
- Clinical trial summary from the National Cancer Institute's PDQ® databaseLink provided by the sponsor.
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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.
Susan Goodin, PharmD, FCCP, BCOP principal investigator
Rutgers Cancer Institute of New Jersey
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dextromethorphan hydrobromide in people with Fatigue and Unspecified Adult Solid Tumor, Protocol Specific, run by University of Medicine and Dentistry of New Jersey at 2 sites in United States.
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: stopped early, as of the sponsor's last update on 17 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 stopped early (reason given: slow accrual). Results are not available in the source record.
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?
Efficacy. 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 17 May 2011.