Trial Outcomes & Findings for Evaluation of the Use of Trental and Vitamin E For Prophylaxis of Radiation Necrosis (NCT NCT01508221)

NCT ID: NCT01508221

Last Updated: 2023-09-14

Results Overview

Number of symptomatic death of healthy tissue caused by radiation therapy.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 31 participants
• Primary outcome timeframe: average 1 year
• Results posted on: 2023-09-14

Participant Flow

Participant milestones

Measure	Trental + Vitamin E Trental 400 mg TID and Vitamin E 400IU BID starting the first day after the last radiosurgery treatment Trental: 400 mg tid starting first day after last radiosurgery treatment and continuing for 6 months Vitamin E: 400IU twice daily starting the first day after last radiosurgery treatment and continuing for 6 months
Overall Study STARTED	31
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the Use of Trental and Vitamin E For Prophylaxis of Radiation Necrosis

Baseline characteristics by cohort

Measure	Trental + Vitamin E n=31 Participants Trental 400 mg TID and Vitamin E 400IU BID starting the first day after the last radiosurgery treatment Trental: 400 mg tid starting first day after last radiosurgery treatment and continuing for 6 months Vitamin E: 400IU twice daily starting the first day after last radiosurgery treatment and continuing for 6 months
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Age, Continuous	56.87 years n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants

PRIMARY outcome

Timeframe: average 1 year

Number of symptomatic death of healthy tissue caused by radiation therapy.

Outcome measures

Measure	Trental + Vitamin E n=31 Participants Trental 400 mg TID and Vitamin E 400IU BID starting the first day after the last radiosurgery treatment Trental: 400 mg tid starting first day after last radiosurgery treatment and continuing for 6 months Vitamin E: 400IU twice daily starting the first day after last radiosurgery treatment and continuing for 6 months
Number of Participants With Symptomatic Radiation Necrosis	1 Participants

Adverse Events

Trental + Vitamin E

Serious events: 0 serious events

Other events: 4 other events

Deaths: 15 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Trental + Vitamin E n=31 participants at risk Trental 400 mg TID and Vitamin E 400IU BID starting the first day after the last radiosurgery treatment Trental: 400 mg tid starting first day after last radiosurgery treatment and continuing for 6 months Vitamin E: 400IU twice daily starting the first day after last radiosurgery treatment and continuing for 6 months
Cardiac disorders Arrhythmia	3.2% 1/31 • Number of events 1 • Adverse Event collection is not specifically mapped out per protocol. The length of the study is 3 years, thus AE collection is up to three years starting from consent. Adverse events were not systematically collected for all subjects.
Gastrointestinal disorders Constipation	3.2% 1/31 • Number of events 1 • Adverse Event collection is not specifically mapped out per protocol. The length of the study is 3 years, thus AE collection is up to three years starting from consent. Adverse events were not systematically collected for all subjects.
Gastrointestinal disorders Nausea	6.5% 2/31 • Number of events 2 • Adverse Event collection is not specifically mapped out per protocol. The length of the study is 3 years, thus AE collection is up to three years starting from consent. Adverse events were not systematically collected for all subjects.
General disorders Fatigue	9.7% 3/31 • Number of events 3 • Adverse Event collection is not specifically mapped out per protocol. The length of the study is 3 years, thus AE collection is up to three years starting from consent. Adverse events were not systematically collected for all subjects.
General disorders Gait disturbance	3.2% 1/31 • Number of events 1 • Adverse Event collection is not specifically mapped out per protocol. The length of the study is 3 years, thus AE collection is up to three years starting from consent. Adverse events were not systematically collected for all subjects.
General disorders Generalized weakness	3.2% 1/31 • Number of events 1 • Adverse Event collection is not specifically mapped out per protocol. The length of the study is 3 years, thus AE collection is up to three years starting from consent. Adverse events were not systematically collected for all subjects.
General disorders Leg swelling	3.2% 1/31 • Number of events 1 • Adverse Event collection is not specifically mapped out per protocol. The length of the study is 3 years, thus AE collection is up to three years starting from consent. Adverse events were not systematically collected for all subjects.
General disorders Non-cardiac chest pain	3.2% 1/31 • Number of events 1 • Adverse Event collection is not specifically mapped out per protocol. The length of the study is 3 years, thus AE collection is up to three years starting from consent. Adverse events were not systematically collected for all subjects.
Metabolism and nutrition disorders Anorexia	6.5% 2/31 • Number of events 2 • Adverse Event collection is not specifically mapped out per protocol. The length of the study is 3 years, thus AE collection is up to three years starting from consent. Adverse events were not systematically collected for all subjects.
Musculoskeletal and connective tissue disorders Back pain	3.2% 1/31 • Number of events 1 • Adverse Event collection is not specifically mapped out per protocol. The length of the study is 3 years, thus AE collection is up to three years starting from consent. Adverse events were not systematically collected for all subjects.
Musculoskeletal and connective tissue disorders Lower back pain	3.2% 1/31 • Number of events 1 • Adverse Event collection is not specifically mapped out per protocol. The length of the study is 3 years, thus AE collection is up to three years starting from consent. Adverse events were not systematically collected for all subjects.
General disorders Orthostatic dizziness	3.2% 1/31 • Number of events 1 • Adverse Event collection is not specifically mapped out per protocol. The length of the study is 3 years, thus AE collection is up to three years starting from consent. Adverse events were not systematically collected for all subjects.
Musculoskeletal and connective tissue disorders Pain in shoulder	3.2% 1/31 • Number of events 1 • Adverse Event collection is not specifically mapped out per protocol. The length of the study is 3 years, thus AE collection is up to three years starting from consent. Adverse events were not systematically collected for all subjects.
Musculoskeletal and connective tissue disorders Right leg weakness	3.2% 1/31 • Number of events 1 • Adverse Event collection is not specifically mapped out per protocol. The length of the study is 3 years, thus AE collection is up to three years starting from consent. Adverse events were not systematically collected for all subjects.
Nervous system disorders Sleep disturbance	3.2% 1/31 • Number of events 1 • Adverse Event collection is not specifically mapped out per protocol. The length of the study is 3 years, thus AE collection is up to three years starting from consent. Adverse events were not systematically collected for all subjects.
Gastrointestinal disorders Vomiting	3.2% 1/31 • Number of events 1 • Adverse Event collection is not specifically mapped out per protocol. The length of the study is 3 years, thus AE collection is up to three years starting from consent. Adverse events were not systematically collected for all subjects.
Metabolism and nutrition disorders Weight loss	3.2% 1/31 • Number of events 1 • Adverse Event collection is not specifically mapped out per protocol. The length of the study is 3 years, thus AE collection is up to three years starting from consent. Adverse events were not systematically collected for all subjects.
Psychiatric disorders Anxiety	9.7% 3/31 • Number of events 3 • Adverse Event collection is not specifically mapped out per protocol. The length of the study is 3 years, thus AE collection is up to three years starting from consent. Adverse events were not systematically collected for all subjects.
Psychiatric disorders Depression	3.2% 1/31 • Number of events 1 • Adverse Event collection is not specifically mapped out per protocol. The length of the study is 3 years, thus AE collection is up to three years starting from consent. Adverse events were not systematically collected for all subjects.
Respiratory, thoracic and mediastinal disorders Cough	6.5% 2/31 • Number of events 2 • Adverse Event collection is not specifically mapped out per protocol. The length of the study is 3 years, thus AE collection is up to three years starting from consent. Adverse events were not systematically collected for all subjects.
Skin and subcutaneous tissue disorders Diaphoresis	3.2% 1/31 • Number of events 1 • Adverse Event collection is not specifically mapped out per protocol. The length of the study is 3 years, thus AE collection is up to three years starting from consent. Adverse events were not systematically collected for all subjects.

Additional Information

Alison Kastl

University of Cincinnati

Phone: 513-584-0436

Email: Kastla@ucmail.uc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place