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

Primary Purpose

Head and Neck Cancer, Non-small Cell Lung Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone
Placebo
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring cancer, radiation therapy, chemotherapy, dexamethasone, corticosteroids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • University of Arizona

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Arm 1 Placebo

Arm 2 Dexamethasone

Arm Description

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

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

Outcomes

Primary Outcome Measures

Fatigue Measured by FACIT-F Version 4 Fatigue Score
To compare the effects of dexamethasone and placebo on radiation fatigue using validated measures

Secondary Outcome Measures

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

Full Information

First Posted
March 30, 2015
Last Updated
April 22, 2019
Sponsor
University of Arizona
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1. Study Identification

Unique Protocol Identification Number
NCT02410382
Brief Title
Dexamethasone for Treatment of Radiation-related Fatigue in Patients Receiving RT for Head-neck and Lung Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
IRB suspension, did not resume
Study Start Date
August 27, 2014 (Actual)
Primary Completion Date
February 16, 2018 (Actual)
Study Completion Date
February 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Non-small Cell Lung Cancer
Keywords
cancer, radiation therapy, chemotherapy, dexamethasone, corticosteroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects receiving radiation therapy or radiation and chemotherapy randomly assigned to placebo bid for 14 days
Arm Title
Arm 2 Dexamethasone
Arm Type
Active Comparator
Arm Description
Subjects receiving radiation therapy or radiation and chemotherapy randomly assigned to dexamethasone 4 mg bid for 14 days
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
corticosteroid
Intervention Description
oral dexamethasone 4 mg bid for 14 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral placebo
Primary Outcome Measure Information:
Title
Fatigue Measured by FACIT-F Version 4 Fatigue Score
Description
To compare the effects of dexamethasone and placebo on radiation fatigue using validated measures
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Quality of Life as Measured by FACIT-F Version 4 Well-Being Score
Description
To determine the effect of dexamethasone on QoL and radiation therapy treatment interruption
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sun Yi, MD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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