NCT01032200 · REGISTRY CONDITION SEARCH

Armodafinil in Treating Fatigue Caused By Radiation Therapy in Patients With Primary Brain Tumors

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2021-09-28

RATIONALE: Armodafinil may help relieve fatigue and improve quality of life in patients with cancer receiving radiation therapy to the brain. PURPOSE: This clinical trial is studying how well armodafinil works in treating fatigue caused by radiation therapy in patients with primary brain tumors.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Retention

→

outcome · POSTED

Adherence

→

outcome · POSTED

Fatigue

→

outcome · POSTED

Sleepiness

→

outcome · POSTED

HVLT-IR

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

eligibility Criteria: Inclusion Criteria * Histologically confirmed primary brain tumor, including any of the following: * Glioblastoma multiforme * Anaplastic astrocytoma * Anaplastic oligodendroglioma * Anaplastic mixed oligoastrocytoma * Low-grade glioma * Meningioma * Ependymoma * Other primary brain tumor histologies * Planning to undergo external-beam cranial radiotherapy (partial- or whole-brain radiotherapy) meeting all of the following criteria: * Total dose ≥ 4,500 cGy * Total number of fractions ≥ 25 fractions * Dose per fraction ≥ 150 cGy PATIENT CHARACTERISTICS: * Karnofsky performance status 60-100% * Hemoglobin ≥ 10.0 g/dL (erythropoietin or transfusion allowed for symptomatically anemic patients with a hemoglobin \< 10 g/dL) * Creatinine ≤ 2 mg/dL * Total bilirubin ≤ 2 times upper limit of normal (ULN) * SGOT and SGPT ≤ 3 times ULN * Not pregnant or nursing * Negative pregnancy test * Sexually active women of childbearing potential must use a reliable method of birth control * It is recommended that patients use non-hormonal contraceptives, in addition to or in place of hormonal contraceptives, during and for one month following treatment with armodafinil * Prior malignancies allowed Exclusion Criteria: * No baseline headaches (i.e., headaches occurring in the week before baseline assessment) of grade 4 severity (defined as severe and disabling headaches, requiring analgesics, and interfering with and preventing function or activities of daily living) * No concurrent uncontrolled illness that may cause fatigue; interfere with drug absorption, distribution, metabolism, or excretion; or limit compliance with study requirements including, but not limited to, any of the following: * Ongoing or active infection * Chronic renal insufficiency * Psychiatric illness (psychosis, psychotic disorder, history of suicide attempt, or actively suicidal) * Extreme social situations (e.g., transportation issues that would preclude study compliance) * Patients with a history of cardiac issues (symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia) should not use armodafinil as it may cause chest pain, palpitations, dyspnea, and transient ischemic T-wave changes on ECG * No history of allergic reaction attributed to modafinil or armodafinil * No anticipated or planned excessive consumption of coffee, tea, and/or caffeine-containing beverages averaging \> 600 mg of caffeine/day (i.e., approximately 6 cups of coffee/day, 12 cups of hot tea/day, or 12 cans of cola/day) PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior fractionated external-beam cranial radiotherapy * More than 30 days since prior monoamine oxidate inhibitors or investigational drugs * More than 2 weeks since prior and no concurrent modafinil (Provigil), donepezil (Aricept), memantine hydrochloride (Namenda), methylphenidate (Ritalin), dextroamphetamine-amphetamine (Adderall), ginkgo biloba, or any other cognitive function-enhancing drugs * At least 4 weeks since prior and no concurrent interstitial or intracavitary chemotherapy and/or radiotherapy or stereotactic radiosurgery (i.e., Gamma Knife, Linac, or Cyberknife) * No concurrent erythropoietin, transfusion, or iron therapy (unless patient is symptomatically anemic with hemoglobin \< 10 g/dL) * Concurrent chemotherapy allowed * Concurrent hormonal therapy for other malignancies allowed * No concurrent non-hormonal therapy (e.g., Herceptin and other targeted agents), or cytotoxic chemotherapy * No concurrent clopidogrel bisulfate (Plavix)
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
intervention Names
Drug: Armodafinil
label
Arm I - Armodafinil
type
EXPERIMENTAL
description
Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
intervention Names
Other: placebo
label
Arm II - Placebo
type
PLACEBO_COMPARATOR

interventions

arm Group Labels
Arm I - Armodafinil
description
Given orally
name
Armodafinil
type
DRUG
arm Group Labels
Arm II - Placebo
description
Given orally
name
placebo
type
OTHER

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: QUADRUPLE
who Masked: PARTICIPANT
CARE_PROVIDER
INVESTIGATOR
OUTCOMES_ASSESSOR

primary Purpose

SUPPORTIVE_CARE

Enrollment

count: 54
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Retention is defined as the percentage of participants who complete the 4 week post-RT questionnaires.
measure
Retention
time Frame
4 weeks post-RT (approximately 3 months post randomization)
description
Adherence is the percentage of ideal number of pills taken while on study (based on returned diaries)
measure
Adherence
time Frame
4 weeks post-RT (approximately 3 months post randomization)

secondary Outcomes

description
Fatigue is measured by the fatigue subscale of the Functional Assessment of Chronic Illness Therapy Questionnaire. It consists of 13 questions each answered on a 0 to 4 scale. The fatigue score is the sum of the responses with some questions reverse scored. The total Score ranges from 0 to 52, with higher scores indicating less fatigue.
measure
Fatigue
time Frame
4 weeks post-RT
description
Sleepiness as measured by the Epworth Sleep Scale. It consists of 8 questions that measure daytime sleepiness in which the patient records their likelihood of dozing or sleeping during a number of routine daily activities. ESS scores range from 0 to 24. Higher scores denote greater sleepiness.
measure
Sleepiness
time Frame
4 weeks post-RT
description
HVLT-IR is the Hopkins Verbal learning test - immediate recall. Participants are given 12 words to remember. They are then asked to recall those words. This is repeated 3 times. Minimum recalled words 0 maximum 36. The HVLT-IR score is the sum of correctly recalled words across the three trials. Higher scores indicate better recall.
measure
HVLT-IR
time Frame
4 weeks post-RT

Full study description

brief Summary: RATIONALE: Armodafinil may help relieve fatigue and improve quality of life in patients with cancer receiving radiation therapy to the brain. PURPOSE: This clinical trial is studying how well armodafinil works in treating fatigue caused by radiation therapy in patients with primary brain tumors.
detailed Description: OBJECTIVES: Primary * To estimate study accrual, adherence, retention, and participation of patients with primary brain tumors undergoing partial- or whole-brain radiotherapy who are randomized to receive armodafinil or placebo. * To estimate the variability of fatigue, quality of life, and neurocognitive function in these patients. Secondary * To obtain a preliminary estimate of the effect of armodafinil on fatigue as measured by the fatigue subscale of the FACIT-F and the Brief Fatigue Inventory. * To estimate the rates of toxicity and adverse events associated with armodafinil. * To obtain preliminary estimates of the effect of armodafinil on sleepiness as measured by the Epworth Sleep Scale; overall quality of life and brain-specific quality of life as measured by the FACT-G with the brain subscale; and cognitive function as measured by a comprehensive Wake Forest Cognitive Function Battery. OUTLINE: This is a multicenter study. Patients are stratified according to therapy (radiotherapy alone vs radiotherapy and chemotherapy) and Karnofsky performance status (60-80% vs 90-100%). Patients are randomized to 1 of 2 arms. * Arm I: Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity. * Arm II: Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity. Patients complete questionnaires assessing fatigue, quality of life, and neurocognitive function at baseline and periodically during study.

Source references

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-ff411dadbeeb17d73857
requested nct id
NCT01032200
primary nct id
NCT01032200
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Pilocytic+Astrocytoma&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
119a798b3a8ac773dc927301b40893d7acb58e99507e3cc7b6aa8527b4e6bb63
payload sha256
7ffc71f7a11b710c9831e4a0e361342a1d8fbb7e09815d94ad61d2ad3dc91d22
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-ff411dadbeeb17d73857
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT01032200
occurrences
context exact
NCT01032200
end
11
exact text
NCT01032200
start
0
offset unit
unicode_code_points
query cond
Pilocytic Astrocytoma
query disease state id
ds-pilocytic-astrocytoma
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-pilocytic-astrocytoma-000.json
source file sha256
119a798b3a8ac773dc927301b40893d7acb58e99507e3cc7b6aa8527b4e6bb63
source json pointer
/studies/4/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
7376f5b8fe8c29c112609a7a901ad1ce0e025e374a3c04af5b3f48412c3fbbb3
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Pilocytic+Astrocytoma&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice