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

NCT ID: NCT02410382

Last Updated: 2019-05-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-27
• Study Completion Date: 2018-02-16

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.

Conditions

Head and Neck Cancer; Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Arm 1 Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

oral placebo

Arm 2 Dexamethasone

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

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

oral dexamethasone 4 mg bid for 14 days

Interventions

Dexamethasone

oral dexamethasone 4 mg bid for 14 days

Intervention Type: DRUG

Placebo

oral placebo

Intervention Type: DRUG

Other Intervention Names

corticosteroid

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sun Yi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

University of Arizona

Tucson, Arizona, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1408439554

Identifier Type: -

Identifier Source: org_study_id