Trial Outcomes & Findings for Dexamethasone for Treatment of Radiation-related Fatigue in Patients Receiving RT for Head-neck and Lung Cancer (NCT NCT02410382)

Results Overview

To compare the effects of dexamethasone and placebo on radiation fatigue using validated measures

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

79 participants

Primary outcome timeframe

12 weeks

Results posted on

2019-05-14

Participant Flow

Study was terminated and data coordinator is no longer in the institution. Sincere efforts were made to gather and report the data, however, no data are available since the study records cannot be located.

Participant milestones

Participant milestones
Measure	Arm 1 Placebo Subjects receiving radiation therapy or radiation and chemotherapy randomly assigned to placebo bid for 14 days Placebo: oral placebo	Arm 2 Dexamethesone Subjects receiving radiation therapy or radiation and chemotherapy randomly assigned to dexamethasone 4 mg bid for 14 days Dexamethasone: oral dexamethasone 4 mg bid for 14 days
Overall Study STARTED	0	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 12 weeks

Population: Data were collected but could not be analyzed. Study terminated by IRB and any data that were gathered, are lost. No data are available for this assessment.

To compare the effects of dexamethasone and placebo on radiation fatigue using validated measures

Outcome measures

Outcome measures
Measure	Arm 1 Placebo Subjects receiving radiation therapy or radiation and chemotherapy randomly assigned to placebo bid for 14 days Placebo: oral placebo	Arm 2 Dexamethesone n=76 Participants Subjects receiving radiation therapy or radiation and chemotherapy randomly assigned to dexamethasone 4 mg bid for 14 days Dexamethasone: oral dexamethasone 4 mg bid for 14 days
Fatigue Measured by FACIT-F Version 4 Fatigue Score	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Data were collected but could not be analyzed. Study terminated by IRB and any data that were gathered, are lost. No data are available for this assessment.

To determine the effect of dexamethasone on QoL and radiation therapy treatment interruption

Outcome measures

Outcome data not reported

Adverse Events

Arm 1 Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2 Dexamethesone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sun K. Yi

University of Arizona

Phone: (520) 694-7236

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place