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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02410382
• Other study ID #: 1408439554
• Status: Terminated
• Phase: Phase 2
• Start date: August 27, 2014
• Est. completion date: February 16, 2018

Study information

• Verified date: April 2019
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 79
• Est. completion date: February 16, 2018
• Est. primary completion date: February 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Fatigue
• Head and Neck Cancer
• Head and Neck Neoplasms
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Dexamethasone
oral dexamethasone 4 mg bid for 14 days
• Placebo
oral placebo

Locations

Country	Name	City	State
United States	University of Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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