FatiguePhase 3NCT00003266
Methylphenidate in Treating Patients With Melanoma
A Phase 3 study testing methylphenidate hydrochloride and quality-of-life assessment in people with Fatigue and Unspecified Adult Solid Tumor, Protocol Specific, run by Eastern Cooperative Oncology Group at 59 sites in 3 countries.
Trial summary
RATIONALE: Methylphenidate may relieve some of the side effects of chemotherapy in patients with melanoma. It is not known whether receiving methylphenidate is more effective than receiving no further therapy in treating patients with melanoma. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Fatigue, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- methylphenidate hydrochloride and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 59 sitesin 3 countries
- Study dates
- 12 Oct 1999to May 2002
- Phase
- Phase 3
- 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: On interferon alfa-2b treatment for at least 8 weeks Dose must be stable for 2 weeks prior to and during study Fatigue level at least 4 on the Symptom and Fatigue Self Evaluation Form (0 none, 10 worst possible)
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: More than 4 weeks Hematopoietic: Hematocrit at least 30% Hepatic: Not specified Renal: Creatinine no greater than 2.0 mg/dL Other: No history of any of the following: Chronic use of anticonvulsants Seizure disorder Motor tics Glaucoma Family history or diagnosis of Tourette's disorder No allergic reaction or hypersensitivity to methylphenidate Cognitively able to participate Not incarcerated Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: See Disease Characteristics No monoamine oxidase inhibitors within 2 months
Trial locations and contacts
59 sites in 3 countries.
59 sites in 3 countries
United States57 sites
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
New England Medical Center Hospital
Boston, Massachusetts, 02111
Veterans Affairs Medical Center - Brooklyn
Brooklyn, New York, 11209
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, 60611
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, 30033
CCOP - Central Illinois
Decatur, Illinois, 62526
CCOP - Colorado Cancer Research Program, Inc.
Denver, Colorado, 80209-5031
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
CCOP - Duluth
Duluth, Minnesota, 55805
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, 07018-1095
CCOP - Evanston
Evanston, Illinois, 60201
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
Veterans Affairs Medical Center - Gainsville
Gainesville, Florida, 32608-1197
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, 46202
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, 54449
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, 53295
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
Nashville, Tennessee, 37212
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
CCOP - Ochsner
New Orleans, Louisiana, 70121
Veterans Affairs Medical Center - New York
New York, New York, 10010
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, 10016
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68131
Veterans Affairs Medical Center - Palo Alto
Palo Alto, California, 94304
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102-1192
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Veterans Affairs Medical Center - Pittsburgh
Pittsburgh, Pennsylvania, 15240
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
University of Rochester Cancer Center
Rochester, New York, 14642
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
Stanford University Medical Center
Stanford, California, 94305-5408
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
Veterans Affairs Medical Center - Tampa (Haley)
Tampa, Florida, 33612
Albert Einstein Comprehensive Cancer Center
The Bronx, New York, 10461
MBCCOP-Our Lady of Mercy Cancer Center
The Bronx, New York, 10466
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
CCOP - Oklahoma
Tulsa, Oklahoma, 74136
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096
About this study
Official title: Double-Blind Randomized Trial of Methylphenidate for Alleviation of Fatigue and Lethargy Associated With Interferon Alpha 2b
RATIONALE: Methylphenidate may relieve some of the side effects of chemotherapy in patients with melanoma. It is not known whether receiving methylphenidate is more effective than receiving no further therapy in treating patients with melanoma.
PURPOSE: Randomized phase III trial to determine if methylphenidate is more effective than no further therapy for the relief of fatigue and drowsiness in treating patients with melanoma who have received high-dose interferon alfa for 8-24 weeks.
Read the detailed description
OBJECTIVES: I. Determine whether methylphenidate decreases fatigue and lethargy in cancer patients receiving interferon alfa. II. Determine whether the use of methylphenidate in this patient population decreases the number of dose reductions of interferon alfa due to toxicities other than myelosuppression or elevated liver function tests. III. Assess whether efficacy or toxicity of methylphenidate in this patient population is concentration dependent. IV. Compare the fatigue subscale and the proposed Brief Fatigue Inventory.
OUTLINE: This is a randomized, double-blind, placebo-controlled, two arm study. Patients are stratified according to initial fatigue level (high vs moderate), and treatment with tumor vaccine (yes vs no). Patients are randomized to one of two treatment arms. Arm I: Patients receive oral methylphenidate twice daily. Arm II: Patients receive oral placebo twice daily. Treatment is continued for 21 consecutive days with dose escalations as tolerated and as needed by patient judgement, followed by an additional week to evaluate the effect of drug withdrawal. Patients are contacted by telephone at least twice weekly during the 21 day treatment and 7 day washout phase to assess adverse or rebound effects. Before the study begins and at weekly clinic visits for the 4 week study period, patients complete a series of questionnaires to measure mood, levels of fatigue and lethargy, and sense of well being. Patients also keep a short daily diary of study medication doses and degree of tiredness. Patients are followed every 3 months for 2 years, then every 6 months for the next 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 200 patients will be accrued into this study within 39 months.
- Being tested
- methylphenidate hydrochloride, quality-of-life assessment
- Keywords
- unspecified adult 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.
methylphenidate hydrochlorideDrug
quality-of-life assessmentProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2003 (estimated)
- Study start12 Oct 1999
- Primary completionMay 2002
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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Cooperative Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Paul R. Hutson, PharmD, Study chair, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003266
- Sponsor's protocol ID
- CDR0000066161
- Other IDs
- E-2Z96, NCI-P98-0130
- Status last verified
- Jun 2023
- First submitted
- 1 Nov 1999
- Last updated
- 18 Jun 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind Randomized Trial of Methylphenidate for Alleviation of Fatigue and Lethargy Associated With Interferon Alpha 2b
- ClinicalTrials.gov ID
- NCT00003266
- Acronym / sponsor ID
- CDR0000066161
- Keywords
- unspecified adult solid tumor, protocol specific, fatigue
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Eastern Cooperative Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 12 Oct 1999 (actual)
- Primary completion
- May 2002 (actual)
- First posted
- 28 Oct 2003 (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: Methylphenidate may relieve some of the side effects of chemotherapy in patients with melanoma. It is not known whether receiving methylphenidate is more effective than receiving no further therapy in treating patients with melanoma.
PURPOSE: Randomized phase III trial to determine if methylphenidate is more effective than no further therapy for the relief of fatigue and drowsiness in treating patients with melanoma who have received high-dose interferon alfa for 8-24 weeks.
Detailed description
OBJECTIVES: I. Determine whether methylphenidate decreases fatigue and lethargy in cancer patients receiving interferon alfa. II. Determine whether the use of methylphenidate in this patient population decreases the number of dose reductions of interferon alfa due to toxicities other than myelosuppression or elevated liver function tests. III. Assess whether efficacy or toxicity of methylphenidate in this patient population is concentration dependent. IV. Compare the fatigue subscale and the proposed Brief Fatigue Inventory.
OUTLINE: This is a randomized, double-blind, placebo-controlled, two arm study. Patients are stratified according to initial fatigue level (high vs moderate), and treatment with tumor vaccine (yes vs no). Patients are randomized to one of two treatment arms. Arm I: Patients receive oral methylphenidate twice daily. Arm II: Patients receive oral placebo twice daily. Treatment is continued for 21 consecutive days with dose escalations as tolerated and as needed by patient judgement, followed by an additional week to evaluate the effect of drug withdrawal. Patients are contacted by telephone at least twice weekly during the 21 day treatment and 7 day washout phase to assess adverse or rebound effects. Before the study begins and at weekly clinic visits for the 4 week study period, patients complete a series of questionnaires to measure mood, levels of fatigue and lethargy, and sense of well being. Patients also keep a short daily diary of study medication doses and degree of tiredness. Patients are followed every 3 months for 2 years, then every 6 months for the next 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 200 patients will be accrued into this study within 39 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- Double blind
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 |
|---|---|---|
| methylphenidate hydrochloride | Drug | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
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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.
Paul R. Hutson, PharmD study chair
University of Wisconsin, Madison
59 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing methylphenidate hydrochloride and quality-of-life assessment in people with Fatigue and Unspecified Adult Solid Tumor, Protocol Specific, run by Eastern Cooperative Oncology Group at 59 sites in 3 countries.
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: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in United States, Puerto Rico, South Africa. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 18 Jun 2023.