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

Phase 2

Terminated

• Conditions: Head and Neck Cancer; Non-small Cell Lung Cancer
• Interventions: Drug: Placebo; Drug: Dexamethasone

• Registration Number: NCT02410382
• Lead Sponsor: University of Arizona

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.

Study Timeline

• Study Start: 2014-08-27
• Study First Submitted: 2015-03-30
• Study First Submitted QC: 2015-04-01
• Study First Posted: 2015-04-07
• Primary Completion: 2018-02-16
• Study Completion: 2018-02-16
• Results First Submitted: 2019-03-29
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-22
• Last Update Submitted: 2019-04-22
• Results First Posted: 2019-05-14
• Last Update Posted: 2019-05-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 79

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1 Placebo	Placebo	Subjects receiving radiation therapy or radiation and chemotherapy randomly assigned to placebo bid for 14 days
Arm 2 Dexamethasone	Dexamethasone	Subjects receiving radiation therapy or radiation and chemotherapy randomly assigned to dexamethasone 4 mg bid for 14 days

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Arizona; 🇺🇸 Tucson, Arizona, United States