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

University of Arizona

Status and phase: Terminated; Phase 2

Conditions: Non-small Cell Lung Cancer; Head and Neck Cancer

Treatments: Drug: Dexamethasone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02410382

1408439554

Details and patient eligibility

About

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.

Full 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.

Enrollment: 79 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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79 participants in 2 patient groups, including a placebo group

Arm 1 Placebo

Placebo Comparator group

Description:

Subjects receiving radiation therapy or radiation and chemotherapy randomly assigned to placebo bid for 14 days

Treatment:

Drug: Placebo

Arm 2 Dexamethasone

Active Comparator group

Description:

Subjects receiving radiation therapy or radiation and chemotherapy randomly assigned to dexamethasone 4 mg bid for 14 days

Treatment:

Drug: Dexamethasone