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

• Status: Terminated
• Trial end date: 2018-02-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Arizona
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

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)