Dextromethorphan in Treating Patients With Fatigue Caused by Cancer
This study has been terminated.
(slow accrual)
Sponsor:
University of Medicine and Dentistry New Jersey
Collaborator:
Information provided by:
University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT00176540
First received: September 12, 2005
Last updated: May 16, 2011
Last verified: May 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Fatigue Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: dextromethorphan hydrobromide |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | A Pilot Trial to Evaluate the Effects of Dextromethorphan in Patients Suffering From Cancer-Related Fatigue |
Resource links provided by NLM:
Further study details as provided by University of Medicine and Dentistry New Jersey:
Primary Outcome Measures:
- Efficacy
Secondary Outcome Measures:
- Correlation of the changes in cancer-related fatigue with the levels of plasma homocysteine versus red blood cell folate
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2003 |
| Study Completion Date: | August 2007 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 12 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00176540
Locations
| United States, New Jersey | |
| Cancer Institute of New Jersey at Hamilton | |
| Hamilton, New Jersey, United States, 08690 | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | |
| New Brunswick, New Jersey, United States, 08903 | |
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Investigators
| Principal Investigator: | Susan Goodin, PharmD, FCCP, BCOP | Cancer Institute of New Jersey |
More Information
Additional Information:
No publications provided
| Responsible Party: | Susan Goodin, MD, UMDNJ/CINJ |
| ClinicalTrials.gov Identifier: | NCT00176540 History of Changes |
| Other Study ID Numbers: | CDR0000539650, P30CA072720, CINJ-5017v2, CINJ-4598, CINJ-NJ11005 |
| Study First Received: | September 12, 2005 |
| Last Updated: | May 16, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Medicine and Dentistry New Jersey:
|
unspecified adult solid tumor, protocol specific unspecified childhood solid tumor, protocol specific fatigue |
Additional relevant MeSH terms:
|
Fatigue Neoplasms Signs and Symptoms Dextromethorphan Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Antitussive Agents Central Nervous System Agents Therapeutic Uses Respiratory System Agents |
ClinicalTrials.gov processed this record on June 18, 2013