NCT02410382

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Cancer
• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Dexamethasone	oral dexamethasone 4 mg bid for 14 days
DRUG	Placebo	oral placebo

Timeline

• Start date: 2014-08-27
• Primary completion: 2018-02-16
• Completion: 2018-02-16
• First posted: 2015-04-07
• Last updated: 2019-05-14
• Results posted: 2019-05-14

Locations

1 site across 1 country: United States