Clinical trial NCT02410382: Dexamethasone for Treatment of Radiation-related Fatigue in Patients Receiving RT for Head-neck and Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Head and Neck Cancer
Non-small Cell Lung Cancer
Keywords: cancer
radiation therapy
chemotherapy
dexamethasone
corticosteroids
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2015-04-07
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Fatigue Measured by FACIT-F Version 4 Fatigue Score
timeFrame: 12 weeks
Secondary outcomes:
measure: Quality of Life as Measured by FACIT-F Version 4 Well-Being Score
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: University of Arizona
name: Sun Yi, MD
role: PRINCIPAL_INVESTIGATOR
References: