Head and Neck CancerPhase 2NCT02410382
Dexamethasone for Treatment of Radiation-related Fatigue in Patients Receiving RT for Head-neck and Lung Cancer
A Phase 2 study testing Dexamethasone in people with Head and Neck Cancer and Non-small Cell Lung Cancer, run by University of Arizona at 1 site in United States.
Trial summary
This study will look at how dexamethasone and placebo influence radiation fatigue, quality of life and number of treatment days missed during radiation therapy or radiation therapy and chemotherapy for cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Non-small Cell Lung Cancer
- What is being tested?
- Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2014to 16 Feb 2018
- Phase
- Phase 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
- confirmation of head \& neck cancer (stage I-IV) or non-small cell lung cancer (stage II \& III)
- Undergoing treatment with either radiation alone or in combination with chemotherapy
- Normal cognition and willingness to complete fatigue and quality of life forms, patient observation form, and pill diary
Who cannot join
- Hypersensitivity to dexamethasone or corticosteroids or Equal sugar substitute
- Corticosteroid within the past 30 days prior to study enrollment for greater than one week duration
- Planned Stereotactic Body Radiation Therapy (SBRT)
- Active psychosis
- Current pregnancy
- Active peptic ulcer disease or evidence of gastrointestinal bleed
Show all 13Show fewer
- Current active tuberculosis or systemic fungal infection
- Previous diagnosis of diabetes mellitus
- Acute febrile illness
- Known human immunodeficiency virus or acquired immunodeficiency syndrome
- Major surgery within two weeks of study enrollment of which the patient has not recovered
- Psychostimulant use in the past 30 days prior to registration
- History of phenylketonuria (PKU)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Randomized Study of Short-Term Dexamethasone Versus Placebo for Fatigue in Patients Receiving Radiation Alone or Radiation and Chemotherapy for the Treatment of Head and Neck and Non-Small Cell Lung Cancers
This study will look at how dexamethasone and placebo influence radiation fatigue, quality of life and number of treatment days missed during radiation therapy or radiation therapy and chemotherapy for cancer.
Read the detailed description
Subjects will randomly receive either dexamethasone or placebo and begin the study medication during the midpoint of their radiation treatment. Study medication will be taken for 14 straight days then stopped. Fatigue and quality of life will be measured weekly with short patient completed surveys. The number of breaks taken during radiation treatment will also be tracked. For safety, blood sugar levels will be checked with finger stick blood draws because dexamethasone is known to cause these levels to increase. Study participation will be approximately 3 months.
- Conditions
- Head and Neck Cancer, Non-small Cell Lung Cancer
- Being tested
- Dexamethasone, Placebo
- Keywords
- cancer, radiation therapy, chemotherapy, dexamethasone, corticosteroids
- Medical subject headings
- Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called corticosteroid
oral dexamethasone 4 mg bid for 14 days
PlaceboDrug
oral placebo
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Placebo | Placebo comparator | Subjects receiving radiation therapy or radiation and chemotherapy randomly assigned to placebo bid for 14 days Receives: Drug: Placebo |
| Arm 2 Dexamethasone | Active comparator | Subjects receiving radiation therapy or radiation and chemotherapy randomly assigned to dexamethasone 4 mg bid for 14 days Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Measured by FACIT-F Version 4 Fatigue Score
To compare the effects of dexamethasone and placebo on radiation fatigue using validated measures
Measured: 12 weeks
Secondary outcomes (1)
Quality of Life as Measured by FACIT-F Version 4 Well-Being Score
To determine the effect of dexamethasone on QoL and radiation therapy treatment interruption
Measured: 12 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 2015 (estimated)
- Study start27 Aug 2014
- Primary completion16 Feb 2018
- Study completion16 Feb 2018
Why it stopped: IRB suspension, did not resume
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 University of ArizonaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sun Yi, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02410382
- Sponsor's protocol ID
- 1408439554
- Status last verified
- Apr 2019
- First submitted
- 30 Mar 2015
- Last updated
- 14 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Study of Short-Term Dexamethasone Versus Placebo for Fatigue in Patients Receiving Radiation Alone or Radiation and Chemotherapy for the Treatment of Head and Neck and Non-Small Cell Lung Cancers
- ClinicalTrials.gov ID
- NCT02410382
- Acronym / sponsor ID
- 1408439554
- Conditions
- Head and Neck Cancer, Non-small Cell Lung Cancer
- Keywords
- cancer, radiation therapy, chemotherapy, dexamethasone, corticosteroids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IRB suspension, did not resume
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 27 Aug 2014 (actual)
- Primary completion
- 16 Feb 2018 (actual)
- Study completion
- 16 Feb 2018 (actual)
- First posted
- 7 Apr 2015 (estimated)
- Results
- Posted 14 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will look at how dexamethasone and placebo influence radiation fatigue, quality of life and number of treatment days missed during radiation therapy or radiation therapy and chemotherapy for cancer.
Detailed description
Subjects will randomly receive either dexamethasone or placebo and begin the study medication during the midpoint of their radiation treatment. Study medication will be taken for 14 straight days then stopped. Fatigue and quality of life will be measured weekly with short patient completed surveys. The number of breaks taken during radiation treatment will also be tracked. For safety, blood sugar levels will be checked with finger stick blood draws because dexamethasone is known to cause these levels to increase. Study participation will be approximately 3 months.
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 |
|---|---|---|
| Arm 1 Placebo | Placebo comparator | Drug: PlaceboSubjects receiving radiation therapy or radiation and chemotherapy randomly assigned to placebo bid for 14 days |
| Arm 2 Dexamethasone | Active comparator | Drug: DexamethasoneSubjects receiving radiation therapy or radiation and chemotherapy randomly assigned to dexamethasone 4 mg bid for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- confirmation of head \& neck cancer (stage I-IV) or non-small cell lung cancer (stage II \& III)
- Undergoing treatment with either radiation alone or in combination with chemotherapy
- Normal cognition and willingness to complete fatigue and quality of life forms, patient observation form, and pill diary
Key exclusion criteria (13 listed)
- Hypersensitivity to dexamethasone or corticosteroids or Equal sugar substitute
- Corticosteroid within the past 30 days prior to study enrollment for greater than one week duration
- Planned Stereotactic Body Radiation Therapy (SBRT)
- Active psychosis
- Current pregnancy
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 |
|---|---|---|
| DexamethasoneAlso: corticosteroidoral dexamethasone 4 mg bid for 14 days | Drug | Arm 2 Dexamethasone |
| Placebooral placebo | Drug | Arm 1 Placebo |
Primary outcome
Fatigue Measured by FACIT-F Version 4 Fatigue Score
Time frame: 12 weeks
To compare the effects of dexamethasone and placebo on radiation fatigue using validated measures
1 secondary outcome
Quality of Life as Measured by FACIT-F Version 4 Well-Being Score
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Sun Yi, MD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexamethasone in people with Head and Neck Cancer and Non-small Cell Lung Cancer, run by University of Arizona at 1 site 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 3 inclusion and 13 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: stopped early, as of the sponsor's last update on 14 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 phase mean?
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 May 2019). 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?
Fatigue Measured by FACIT-F Version 4 Fatigue Score (time frame: 12 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 May 2019.