Dexamethasone for Treatment of Radiation-related Fatigue in Patients Receiving RT for Head-neck and Lung Cancer

Study Overview
=================
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.

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

Conditions
-----------------
Head and Neck Cancer, Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Dexamethasone
* Drug: Placebo


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Arm 1 Placebo<br>Subjects receiving radiation therapy or radiation and chemotherapy randomly assigned to placebo bid for 14 days | Drug: Placebo<br>* oral placebo<br>|
| Active Comparator: Arm 2 Dexamethasone<br>Subjects receiving radiation therapy or radiation and chemotherapy randomly assigned to dexamethasone 4 mg bid for 14 days | Drug: Dexamethasone<br>* oral dexamethasone 4 mg bid for 14 days<br>* Other names: corticosteroid;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue Measured by FACIT-F Version 4 Fatigue Score | To compare the effects of dexamethasone and placebo on radiation fatigue using validated measures | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, radiation therapy, chemotherapy, dexamethasone, corticosteroids