Clinical trial · Interventional
Dexamethasone for Treatment of Radiation-related Fatigue in Patients Receiving RT for Head-neck and Lung Cancer
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
NCT02410382CI-TRIAL-00038601terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): IRB suspension, did not resume
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Arm 1 Placebo
- description
- Subjects receiving radiation therapy or radiation and chemotherapy randomly assigned to placebo bid for 14 days
- interventionNames
- Drug: Placebo
- type
- ACTIVE_COMPARATOR
- label
- Arm 2 Dexamethasone
- description
- Subjects receiving radiation therapy or radiation and chemotherapy randomly assigned to dexamethasone 4 mg bid for 14 days
- interventionNames
- Drug: Dexamethasone
Primary outcomes (1)
- measure
- Fatigue Measured by FACIT-F Version 4 Fatigue Score
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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)
References
Publications (0)
Data not yet available
No reference posted for this study.