Methylphenidate HCl or Modafinil in Treating Young Patients With Excessive Daytime Sleepiness After Cancer Therapy

NCT01348607 | Terminated Phase 2 Results DMC

• 3 other identifiers: SCUSF 0803SCUSF-08035U10CA081920-11
• Study Type: interventional
• Target: 1
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Methylphenidate hydrochloride or modafinil may help reduce daytime sleepiness and improve the quality of life of patients with excessive daytime sleepiness after cancer therapy. It is not yet known whether methylphenidate hydrochloride or modafinil are more effective than a placebo in reducing daytime sleepiness in these patients. PURPOSE: This randomized phase II trial is studying methylphenidate hydrochloride or modafinil to see how well they work compared with a placebo in treating young patients with excessive daytime sleepiness after cancer therapy.

Conditions

Central Nervous System Tumor, Pediatric; Fatigue; Specific Disorders of Sleep

Keywords

psychosocial effects of cancer and its treatment; sleep disorders; fatigue; childhood craniopharyngioma

Outcome Measures

Primary Outcomes (1)

• Average Daytime Napping Minutes in a Week

  Outcome measure was the total of daytime napping minutes in a week as assessed by participant sleep diaries

  29 days

Secondary Outcomes (1)

• Adverse Events

  29 days

Study Arms (3)

Arm I - methylphenidate hydrochloride

EXPERIMENTAL

Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.

Drug: methylphenidate hydrochloride

Arm II -modafinil

EXPERIMENTAL

Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.

Drug: modafinil

Arm III placebo

PLACEBO COMPARATOR

Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.

Drug: placebo

Interventions

methylphenidate hydrochloride DRUG

Given orally

Also known as: methylphenidate HCl, Concerta

Arm I - methylphenidate hydrochloride

modafinil DRUG

Given orally

Also known as: Provigil

Arm II -modafinil

placebo DRUG

Given orally

Also known as: potato starch placebo, placebo capsule

Arm III placebo

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patient and family must agree to return to the clinic up to 8 times within 2 months
• Children ≥ 8 and \<18 years of age at the time of study entry who were previously treated for:
• a hypothalamic tumor
• mid-line brain tumor
• a tumor involving one or both thalami
• craniopharyngioma
• diagnosis of hydrocephalus secondary to a brain tumor or treatment of a brain tumor that required placement of a permanent shunt.
• Off cancer treatment for at least six months
• Proficient in English
• Able to swallow capsules
• Experiencing symptoms of excessive daytime sleepiness (EDS) for at least three months prior to study entry that is not a result of inadequate sleep hygiene or other known medical disorder.
• Negative pregnancy test

You may not qualify if:

• Patients treated with doxorubicin or high dose cyclophosphamide
• History of a clinically significant drug sensitivity to methylphenidate, modafinil, armodafinil or any of their components
• Known cardiac disorders including arrhythmias, hypertension requiring treatment or structural heart disease
• Have taken methylphenidate or modafinil within the last 14 days
• Current/concurrent use of antihistamines, benzodiazepine, anticonvulsants or alcohol
• Clinical diagnosis of major depression, subclinical depression, or anxiety disorder
• History of psychosis or mania
• Patients with suicidal ideation
• Diagnosis with anemia, untreated hypothyroidism, mononucleosis or narcolepsy
• History of substance abuse
• Pregnant or breast feeding
• A total dietary intake of more than 500 mg of caffeine per day (e.g., approximately ten 330 mL cans of soft drinks, five cups of coffee or tea, or 750 g chocolate per day).

Sponsors & Collaborators

• University of South Florida: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Central Nervous System Neoplasms; Fatigue; Sleep Wake Disorders

Interventions

Methylphenidate; Modafinil

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Limitations and Caveats

This study was closed prior to completion due to a lack of feasibility and low accrual by the Data Monitoring and Safety Board (DSMB).

Results Point of Contact

• Title: Cristina Burroughs, Clinical Research Administrator
• Organization: SunCoast CCOP Research Base

Cristina.Burroughs@epi.usf.edu

(813) 396-9237

Study Officials

• Gerald Rosen, MD

  Children's Hospitals and Clinics of Minnesota - St. Paul

  STUDY CHAIR

• Tom Geller, MD

  St. Louis University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2011
• First Posted: May 5, 2011
• Study Start: July 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 21, 2014
• Results First Posted: September 19, 2013

Record last verified: 2014-01