Head and Neck Cancer, Non-small Cell Lung Cancer
Conditions
Keywords
cancer, radiation therapy, chemotherapy, dexamethasone, corticosteroids
Brief 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.
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.
Interventions
DRUGDexamethasone
oral dexamethasone 4 mg bid for 14 days
DRUGPlacebo
oral placebo
Sponsors
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Measured by FACIT-F Version 4 Fatigue Score | 12 weeks | To compare the effects of dexamethasone and placebo on radiation fatigue using validated measures |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life as Measured by FACIT-F Version 4 Well-Being Score | 12 weeks | To determine the effect of dexamethasone on QoL and radiation therapy treatment interruption |
Countries
United States
Participant flow
Pre-assignment details
Study was terminated and data coordinator is no longer in the institution. Sincere efforts were made to gather and report the data, however, no data are available since the study records cannot be located.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 Placebo Subjects receiving radiation therapy or radiation and chemotherapy randomly assigned to placebo bid for 14 days
Placebo: oral placebo | 0 |
| Arm 2 Dexamethesone Subjects receiving radiation therapy or radiation and chemotherapy randomly assigned to dexamethasone 4 mg bid for 14 days
Dexamethasone: oral dexamethasone 4 mg bid for 14 days | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Fatigue Measured by FACIT-F Version 4 Fatigue Score
To compare the effects of dexamethasone and placebo on radiation fatigue using validated measures
Time frame: 12 weeks
Population: Data were collected but could not be analyzed. Study terminated by IRB and any data that were gathered, are lost. No data are available for this assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1 Placebo | Fatigue Measured by FACIT-F Version 4 Fatigue Score | 0 Participants |
| Arm 2 Dexamethesone | Fatigue Measured by FACIT-F Version 4 Fatigue Score | 0 Participants |
Secondary
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
Time frame: 12 weeks
Population: Data were collected but could not be analyzed. Study terminated by IRB and any data that were gathered, are lost. No data are available for this assessment.