Head And Neck CancerPhase 1/2NCT01330446
Single Agent Armodafinil for Patient-Reported Fatigue Following Radiation Therapy for Head and Neck Cancer
A Phase 1/2 study testing Armodafinil and Questionnaires in people with Head And Neck Cancer and Fatigue, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial summary
The goal of this clinical research study is to learn if armodafinil can reduce fatigue and other common symptoms in patients that have received treatment for head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head And Neck Cancer, Fatigue
- What is being tested?
- Armodafinil and Questionnaires
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 May 2011to 8 Dec 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who were treated with either definitive or postoperative radiation or chemoradiation therapy for HNC with moderate to severe levels of patient reported fatigue, at 6 or more weeks after completing all planned cancer therapy. Patients who rated their fatigue level at 5 or greater on a 0 to 10 scale during any follow-up clinic visits at MD Anderson.
- Male and female patients >= 18 years old.
- Patients who speak English (due to the novel research and its complexity, we are only accruing English-speaking patients to the protocol).
- Patients must agree to discontinue any current herbal supplement use, and refrain from taking any herbal supplement while on protocol.
- Patients must be willing and able to review and understand informed consent documents and to provide written consent.
- Women of childbearing potential (women who are not postmenopausal for at least 1 year and are not surgically sterile) must have a negative urine pregnancy test.
- Sexually active males and females must agree to use effective birth control or to be abstinent for the duration of the study period.
- Women currently taking birth control pills or planning to start birth control pills must agree to an additional method of birth control (either abstinence or a barrier method) while on the study medication and for 1 additional month after study completion.
Who cannot join
- Patients who rated their fatigue level at 4 or less over the past 24 hours based on the fatigue at its worst item of the BFI.
- Patients with clinical evidence of active persistent cancer or progressive disease after completing planned cancer therapy, or with active recurrent cancer.
- Patients with potential medical or other underlying causes of fatigue, as determined by the treating physician or PI
- Patients with Hb <10.5 g/dL within previous 2 weeks.
- Patients with untreated or uncontrolled hypothyroidism, or TSH > ULN or free T4 < lower level of normal within previous 2 weeks.
- Patients with underlying cardiac or pulmonary disease resulting in dyspnea, hypoxia, or hypercapnia.
Show all 28Show fewer
- Patients with a Karnofsky performance status <70
- Patients less than 18 years old
- Patients who are enrolled and receiving active treatment in other symptom intervention trials or who are in the treatment phase of another clinical trial
- Patients with pre-existing psychosis or bipolar disorder
- Patients with pre-existing renal impairment, as evidenced by serum creatinine > ULN on the most recent blood work, done at least within the previous 2 weeks.
- Patients with pre-existing cirrhosis or hepatic impairment or with abnormal liver function test as evidenced by total bilirubin > 1.5 x ULN or 2 times the upper limit of normal of alkaline phosphatase (ALP), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) on the most recent blood work, done at least within the previous 2 weeks.
- Patients with pre-existing Tourette's syndrome
- Patients who have used monoamine oxidase (MAO inhibitors) within the past 14 days
- Patients undergoing abrupt discontinuation of ethanol or sedatives (including benzodiazepines)
- Patients currently taking, or having taken within the previous 1 month, armodafinil, modafinil, amphetamine, or methylphenidate
- Patients on anticoagulants (i.e. warfarin, coumadin, or heparin) or clopidogrel
- Patients with a history of clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies or drug reactions
- Patients with a history of angina or cardiac ischemia, a recent history of myocardial infarction (within the past 1 year) or left ventricular hypertrophy, or patients with mitral valve prolapse
- Patients with uncontrolled hypertension or tachycardia, as determined by treating physician
- Patients who are pregnant, breastfeeding, or planning to become pregnant during the study period and for 1 month after stopping the study drug.
- Female patients who are currently on birth control pills as primary means of contraception, but are not willing to seek an additional effective method of contraception (such as barrier method) during the study period and for 1 month after stopping the study drug.
- Patients with a history of CNS stimulant abuse, such as methylphenidate, dextroamphetamine, or modafinil.
- Patients with major depressive disorder or severe depression (a score of 13 or greater on the BDI Fast Screen (BDI-FS). If this is the case, we will notify their treating physician for appropriate management or referral.
- Patients with current or a history of suicidal ideation.
- Patients currently taking midazolam, cyclosporine, ethinyl estradiol, or triazolam
- Patients currently taking carbamazepine, phenobarbital, rifampin, aminoglutethimide, nafcillin, nevirapine, phenytoin, azole antifungals, clarithromycin, diclofenac, doxycycline, erythromycin, imatinib, isoniazid, nefazodone, nicardipine, propofol, protease inhibitors, quinidine, telithromycin, or verapamil
- Patients currently taking omeprazole, diazepam, propanolol, chlomipramine (or other tricyclic antidepressants), citalopram, methsuximide, or sertraline.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lyndon B. Johnson General Hospital
Houston, Texas, 77026
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Armodafinil for Persistent Patient-Reported Fatigue Following Radiation Therapy for Head and Neck Cancer: a Randomized Phase II Study
The goal of this clinical research study is to learn if armodafinil can reduce fatigue and other common symptoms in patients that have received treatment for head and neck cancer.
Read the detailed description
Armodafinil is designed to stimulate the central nervous system, which may increase wakefulness and reduce fatigue.
A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
Study Groups:
If participant is found eligible to take part in this study, participant will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. Group 1 will take armodafinil. Group 2 will take a placebo. A placebo is a substance that looks like the study drug but has no active ingredients.
Neither participant nor the study staff will know if participant is receiving the study drug or the placebo. However, if needed for participant's safety, the study staff will be able to find out what participant is receiving.
Study Drug Administration:
Participant will take the study drug/placebo every day for 4 weeks starting the morning after participant has enrolled in this study. Participant will take the study drug/placebo in the morning with a full glass (8 ounces) of water. Participant may take the study drug/placebo with or without food. If the dose causes an upset stomach, participant should take it with food. If participant has trouble swallowing the dose of study drug/placebo, the study staff will tell participant of different ways of taking it. Participant will be given a pamphlet with more information about how to take the study drug/placebo.
Symptom Questionnaires:
Before participant starts taking the study drug/placebo, the following tests and procedures will be performed:
°Participant will complete 6 questionnaires about participant's fatigue, sleepiness, and other symptoms as well as participant's quality of life and participant's ability to work. These questionnaires should take about 20 minutes to complete total.
Throughout the study, participant will complete 2 of the symptom questionnaires listed above 2 times every week while participant is on study, including during the Open-label Extension Phase (described below). Participant may complete the questionnaires over the phone using the Interactive Voice Response (IVR) system or with a member of the study staff. Another option is to complete the questionnaires during a routinely scheduled visit outside of this study. If participant completes the questionnaires over the phone, the study staff or the IVR system will call participant at a time that is convenient for participant. If the questionnaires are completed through the IVR system, the study staff will give participant the information participant needs to report participant's symptoms by using the system. If the questionnaires are completed with the study staff, she/he will ask participant the questions and record participant's answers on paper or enter them into a computer.
When participant completes the questionnaires for the second time each week, participant will also be asked if participant is taking participant's study drug/placebo as instructed and participant will be asked about any side effects participant may be having. If the questionnaires were completed through the IVR system, the study staff will contact participant and ask participant if participant is taking participant's study drug/placebo as instructed and about any side effects participant may be having.
At the end of Week 4, participant will complete the same set of 6 questionnaires that participant completed at the beginning of the study. Participant will also complete a questionnaire about participant's thoughts on the study drug/placebo. Participant will also be asked about any changes in drugs (both prescribed and over the counter) that participant may be taking. This should take about 30 minutes.
Open-label Extension:
At the end of Week 4, if participant was in Group 1 and participant did not have any intolerable side effects, participant will be able to continue taking armodafinil for an additional 4 weeks. If participant was in Group 2 and participant did not have any intolerable side effects, participant will be given the option to begin receiving armodafinil for 4 weeks.
No matter what participant chooses, participant will not be told whether participant was taking the study drug or the placebo during the first 4 weeks of the study.
If participant is in the open-label extension phase, at the end of Week 8, participant will complete the same set of 6 questionnaires that participant completed at the beginning of the study. Participant will also complete a questionnaire about participant's thoughts on the study drug/placebo. This should take about 30 minutes.
Length of Treatment:
Participant will receive the study drug/placebo for either 4 or 8 weeks. Participant will be taken off study if intolerable side effects occur or if the study doctor thinks it is in participant's best interest.
Follow-Up:
After participant's last dose of the study drug/placebo, participant will continue to complete 2 symptom questionnaires for another 4 weeks. The last time participant completes the 2 questionnaires, participant will complete an additional 3 questionnaires that participant completed at the beginning of the study.
Additional Information:
Any information about the side effects participant may have that are collected during this study will not be reported to participant's regular doctor. Participant should tell participant's regular doctor about all symptoms and/or side effects that participant had. Participant will given a hot line phone number to call the study staff if participant has any side effects from the study drug/placebo.
Another option to complete the questionnaires at Weeks 4, 8, and 12 is to receive questionnaire packets during the baseline assessment and to mail them back to the study coordinator. The study staff will contact participant to remind participant when it is time to complete them.
This is an investigational study. Armodafinil is FDA-approved and commercially available to treat narcolepsy (falling asleep at unexpected times), obstructive sleep apnea, and shift work sleep disorder. It is also FDA-approved and commercially available to treat sleepiness in patients with excessive sleepiness. Its use in this study is investigational.
Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Head And Neck Cancer, Fatigue
- Being tested
- Armodafinil, Placebo, Questionnaires
- Keywords
- Head and Neck Cancer, HNC, Fatigue, Patient-Reported Fatigue, Fatigue-Symptom Intervention, Postoperative Radiation Therapy, Postoperative Chemoradiation Therapy, Armodafinil, Nuvigil, Placebo, Sugar Pill, Questionnaires, Surveys
- Medical subject headings
- Head and Neck Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArmodafinilDrug
Also called Nuvigil
50 mg the first 3 days, 100 mg the next 4 days, and 150 mg for the remaining treatment period.
PlaceboOther
Also called Sugar Pill
1 by mouth every morning for a 28 day cycle.
QuestionnairesBehavioural
Also called Surveys
Series of questionnaires completed at different time points before, during, and at study completion.
| Study group | Role | What they receive |
|---|---|---|
| Armodafinil | Experimental | 50 mg the first 3 days, 100 mg the next 4 days, and 150 mg for the remaining treatment period. Receives: Drug: Armodafinil; Behavioral: Questionnaires |
| Placebo | Placebo comparator | 1 Placebo by mouth every morning for a 28 day cycle. Receives: Other: Placebo; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Fatigue Inventory-Worst
The primary outcome measure is item 3 on the Brief Fatigue Inventory (BFI) scale: "Please rate your fatigue (weariness, tiredness) by circling the one number that best describes your WORST level of fatigue during past 24 hours." The item is on a 10-point Likert scale from 0 (no fatigue) to 10 (as bad as you can imagine). Thus, higher values represent worse outcomes. The primary outcome measure is the area under the curve (AUC), using the trapezoidal rule, for the BFI-Worst Fatigue scores over 28 days. The range for BFI-Worst Fatigue AUC is from 0 to 280.
Measured: 4-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2011 (estimated)
- Study start19 May 2011
- Primary completion8 Dec 2022
- Study completion8 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head And Neck CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Gary B. Gunn, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330446
- Sponsor's protocol ID
- 2010-0557
- Other IDs
- R01 026582-26, NCI-2011-00881
- Status last verified
- Feb 2024
- First submitted
- 5 Apr 2011
- Last updated
- 14 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Armodafinil for Persistent Patient-Reported Fatigue Following Radiation Therapy for Head and Neck Cancer: a Randomized Phase II Study
- ClinicalTrials.gov ID
- NCT01330446
- Acronym / sponsor ID
- 2010-0557
- Conditions
- Head And Neck Cancer, Fatigue
- Keywords
- Head and Neck Cancer, HNC, Fatigue, Patient-Reported Fatigue, Fatigue-Symptom Intervention, Postoperative Radiation Therapy, Postoperative Chemoradiation Therapy, Armodafinil
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 19 May 2011 (actual)
- Primary completion
- 8 Dec 2022 (actual)
- Study completion
- 8 Dec 2022 (actual)
- First posted
- 7 Apr 2011 (estimated)
- Results
- Posted 14 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if armodafinil can reduce fatigue and other common symptoms in patients that have received treatment for head and neck cancer.
Detailed description
Armodafinil is designed to stimulate the central nervous system, which may increase wakefulness and reduce fatigue.
A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
Study Groups:
If participant is found eligible to take part in this study, participant will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. Group 1 will take armodafinil. Group 2 will take a placebo. A placebo is a substance that looks like the study drug but has no active ingredients.
Neither participant nor the study staff will know if participant is receiving the study drug or the placebo. However, if needed for participant's safety, the study staff will be able to find out what participant is receiving.
Study Drug Administration:
Participant will take the study drug/placebo every day for 4 weeks starting the morning after participant has enrolled in this study. Participant will take the study drug/placebo in the morning with a full glass (8 ounces) of water. Participant may take the study drug/placebo with or without food. If the dose causes an upset stomach, participant should take it with food. If participant has trouble swallowing the dose of study drug/placebo, the study staff will tell participant of different ways of taking it. Participant will be given a pamphlet with more information about how to take the study drug/placebo.
Symptom Questionnaires:
Before participant starts taking the study drug/placebo, the following tests and procedures will be performed:
°Participant will complete 6 questionnaires about participant's fatigue, sleepiness, and other symptoms as well as participant's quality of life and participant's ability to work. These questionnaires should take about 20 minutes to complete total.
Throughout the study, participant will complete 2 of the symptom questionnaires listed above 2 times every week while participant is on study, including during the Open-label Extension Phase (described below). Participant may complete the questionnaires over the phone using the Interactive Voice Response (IVR) system or with a member of the study staff. Another option is to complete the questionnaires during a routinely scheduled visit outside of this study. If participant completes the questionnaires over the phone, the study staff or the IVR system will call participant at a time that is convenient for participant. If the questionnaires are completed through the IVR system, the study staff will give participant the information participant needs to report participant's symptoms by using the system. If the questionnaires are completed with the study staff, she/he will ask participant the questions and record participant's answers on paper or enter them into a computer.
When participant completes the questionnaires for the second time each week, participant will also be asked if participant is taking participant's study drug/placebo as instructed and participant will be asked about any side effects participant may be having. If the questionnaires were completed through the IVR system, the study staff will contact participant and ask participant if participant is taking participant's study drug/placebo as instructed and about any side effects participant may be having.
At the end of Week 4, participant will complete the same set of 6 questionnaires that participant completed at the beginning of the study. Participant will also complete a questionnaire about participant's thoughts on the study drug/placebo. Participant will also be asked about any changes in drugs (both prescribed and over the counter) that participant may be taking. This should take about 30 minutes.
Open-label Extension:
At the end of Week 4, if participant was in Group 1 and participant did not have any intolerable side effects, participant will be able to continue taking armodafinil for an additional 4 weeks. If participant was in Group 2 and participant did not have any intolerable side effects, participant will be given the option to begin receiving armodafinil for 4 weeks.
No matter what participant chooses, participant will not be told whether participant was taking the study drug or the placebo during the first 4 weeks of the study.
If participant is in the open-label extension phase, at the end of Week 8, participant will complete the same set of 6 questionnaires that participant completed at the beginning of the study. Participant will also complete a questionnaire about participant's thoughts on the study drug/placebo. This should take about 30 minutes.
Length of Treatment:
Participant will receive the study drug/placebo for either 4 or 8 weeks. Participant will be taken off study if intolerable side effects occur or if the study doctor thinks it is in participant's best interest.
Follow-Up:
After participant's last dose of the study drug/placebo, participant will continue to complete 2 symptom questionnaires for another 4 weeks. The last time participant completes the 2 questionnaires, participant will complete an additional 3 questionnaires that participant completed at the beginning of the study.
Additional Information:
Any information about the side effects participant may have that are collected during this study will not be reported to participant's regular doctor. Participant should tell participant's regular doctor about all symptoms and/or side effects that participant had. Participant will given a hot line phone number to call the study staff if participant has any side effects from the study drug/placebo.
Another option to complete the questionnaires at Weeks 4, 8, and 12 is to receive questionnaire packets during the baseline assessment and to mail them back to the study coordinator. The study staff will contact participant to remind participant when it is time to complete them.
This is an investigational study. Armodafinil is FDA-approved and commercially available to treat narcolepsy (falling asleep at unexpected times), obstructive sleep apnea, and shift work sleep disorder. It is also FDA-approved and commercially available to treat sleepiness in patients with excessive sleepiness. Its use in this study is investigational.
Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Armodafinil | Experimental | Drug: Armodafinil, Behavioral: Questionnaires50 mg the first 3 days, 100 mg the next 4 days, and 150 mg for the remaining treatment period. |
| Placebo | Placebo comparator | Other: Placebo, Behavioral: Questionnaires1 Placebo by mouth every morning for a 28 day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients who were treated with either definitive or postoperative radiation or chemoradiation therapy for HNC with moderate to severe levels of patient reported fatigue, at 6 or more weeks after completing all planned cancer therapy. Patients who rated their fatigue level at 5 or greater on a 0 to 10 scale during any follow-up clinic visits at MD Anderson.
- Male and female patients >= 18 years old.
- Patients who speak English (due to the novel research and its complexity, we are only accruing English-speaking patients to the protocol).
- Patients must agree to discontinue any current herbal supplement use, and refrain from taking any herbal supplement while on protocol.
- Patients must be willing and able to review and understand informed consent documents and to provide written consent.
Key exclusion criteria (28 listed)
- Patients who rated their fatigue level at 4 or less over the past 24 hours based on the fatigue at its worst item of the BFI.
- Patients with clinical evidence of active persistent cancer or progressive disease after completing planned cancer therapy, or with active recurrent cancer.
- Patients with potential medical or other underlying causes of fatigue, as determined by the treating physician or PI
- Patients with Hb <10.5 g/dL within previous 2 weeks.
- Patients with untreated or uncontrolled hypothyroidism, or TSH > ULN or free T4 < lower level of normal within previous 2 weeks.
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 |
|---|---|---|
| ArmodafinilAlso: Nuvigil50 mg the first 3 days, 100 mg the next 4 days, and 150 mg for the remaining treatment period. | Drug | Armodafinil |
| PlaceboAlso: Sugar Pill1 by mouth every morning for a 28 day cycle. | Other | Placebo |
| QuestionnairesAlso: SurveysSeries of questionnaires completed at different time points before, during, and at study completion. | Behavioural | Armodafinil, Placebo |
Primary outcome
Brief Fatigue Inventory-Worst
Time frame: 4-6 weeks
The primary outcome measure is item 3 on the Brief Fatigue Inventory (BFI) scale: "Please rate your fatigue (weariness, tiredness) by circling the one number that best describes your WORST level of fatigue during past 24 hours." The item is on a 10-point Likert scale from 0 (no fatigue) to 10 (as bad as you can imagine). Thus, higher values represent worse outcomes. The primary outcome measure is the area under the curve (AUC), using the trapezoidal rule, for the BFI-Worst Fatigue scores over 28 days. The range for BFI-Worst Fatigue AUC is from 0 to 280.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- M D Anderson Cancer CenterLink provided by the sponsor.
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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.
Gary B. Gunn, MD principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Armodafinil and Questionnaires in people with Head And Neck Cancer and Fatigue, run by M.D. Anderson Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 28 exclusion criteria. 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 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Brief Fatigue Inventory-Worst (time frame: 4-6 weeks). It is what the study was designed to measure, not a finding.
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 14 Feb 2024.