NCT02410382

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P75+ for phase_2 head-and-neck-cancer

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 27, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 7, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2018

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

May 14, 2019

Completed
Last Updated

May 14, 2019

Status Verified

April 1, 2019

Enrollment Period

3.5 years

First QC Date

March 30, 2015

Results QC Date

March 29, 2019

Last Update Submit

April 22, 2019

Conditions

Head and Neck CancerNon-small Cell Lung Cancer

Keywords

cancerradiation therapychemotherapydexamethasonecorticosteroids

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Quality of Life as Measured by FACIT-F Version 4 Well-Being Score

    12 weeks

Study Arms (2)

Arm 1 Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Arm 2 Dexamethasone

ACTIVE COMPARATOR

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

Drug: Dexamethasone

Interventions

DexamethasoneDRUG

oral dexamethasone 4 mg bid for 14 days

Also known as: corticosteroid
Arm 2 Dexamethasone
PlaceboDRUG

oral placebo

Arm 1 Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsCarcinoma, Non-Small-Cell LungNeoplasms

Interventions

DexamethasoneAdrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Neoplasms by SiteCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

Title
Dr. Sun K. Yi
Organization
University of Arizona
sunkyi@email.arizona.edu
(520) 694-7236

Study Officials

  • Sun Yi, MD

    University of Arizona

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2015

First Posted

April 7, 2015

Study Start

August 27, 2014

Primary Completion

February 16, 2018

Study Completion

February 16, 2018

Last Updated

May 14, 2019

Results First Posted

May 14, 2019

Record last verified: 2019-04

Locations

US(1)