Methylphenidate Treatment of Cancer-Related Fatigue | NCT00758407

Studies
Methylphenidate Treatment of Cancer-Related Fatigue

NCT00758407

Sponsor

Medice Arzneimittel Pütter GmbH & Co KG

Status

Completed

Last Update Posted

Jan 13, 2010Estimated

Enrollment

66Estimated

Phase

Phase 2Phase 3

Conditions

Cancer-related Fatigue

Interventions

Methylphenidate hydrochloride
Placebo

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2006

Primary Completion Date

Jan 2010Actual

Completion Date

Not provided

First Submitted Date

Sep 24, 2008

First Submission Date that Met QC Criteria

Sep 24, 2008

First Posted Date

Sep 25, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2010

Last Update Posted Date

Jan 13, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this randomized controlled clinical trial is to investigate the efficacy and safety of methylphenidate in patients with fatigue caused by cancer.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator		Drug: Methylphenidate hydrochloride
2	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Methylphenidate hydrochloride	Drug	sustained release, dosage according to an individual titration schedule	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
General Fatigue measured by the Multidimensional Fatigue Inventory (Subscale General Fatigue)		6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Quality of Life (EORTC-QLQ C30)		6 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

history of Cancer
MFI >40
Karnofsky Index >=70
outpatient
patient are able to give informed consent

Exclusion Criteria:

treatment with psychostimulants in the past two weeks before screening
active tumor disease
depression (HADS >10)
cachexia (BMI <18kg/m2)
clinically relevant kidney disorders
clinically relevant liver disorder
pathological ECG-finding
high blood pressure
occlusive arterial disease
angina pectoris
cardiac arrhythmias
CHD
post heart-attack status
post stroke status
known elevated intra-ocular pressure
known enlarged prostates
latent and manifest hyperthyreosis
alcohol, medication or drug dependency in the past six months or manifest drug abuse
participation in a clinical study within the past 30 days
participation in this study at an earlier point in time
simultaneous participation in another clinical trial
women of child-bearing age without adequate contraception (contraceptives, intrauterine device , no sexual intercourse)
pregnancy (positive pregnancy test) or lactation period

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Manfred Heim, Prof.	Sonnenbergklinik, Hardstr. 13, D-37242 Bad Sooden-Allendorf	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sonnenbergklinik		Bad Sooden-Allendorf			Germany
Dr. J.-U. Rüffer

Condition Browse Module

MeSH Terms

ID	Term
D005221	Fatigue
D009369	Neoplasms

Ancestor Terms

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008774	Methylphenidate

Ancestor Terms

ID	Term
D010648	Phenylacetates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided