Trial Outcomes & Findings for Normal Tissue Oxygenation Following Radiotherapy (NCT NCT00677040)

Results Overview

Transcutaneous oxygen detector is used to measure the partial pressure of oxygen. The unit detects electrolytes ionized by oxygen. The measuring electrode also heats the skin being measured to facilitate maximal bloodflow to the area.

Recruitment status

COMPLETED

Target enrollment

20 participants

Primary outcome timeframe

One visit for 20 minutes

Results posted on

2024-11-15

Participant Flow

Participant milestones

Participant milestones
Measure	Subjects patients were invited to participate one year after completing radiotherapy as part of their treatment for breast preservation cancer treatment
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Normal Tissue Oxygenation Following Radiotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects n=20 Participants patients were invited to participate one year after completing radiotherapy as part of their treatment for breast preservation cancer treatment
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	63 years n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants
tissue oxygenation of nontreated breast	66.3 mmHg STANDARD_DEVIATION 22.8 • n=5 Participants

PRIMARY outcome

Timeframe: One visit for 20 minutes

Transcutaneous oxygen detector is used to measure the partial pressure of oxygen. The unit detects electrolytes ionized by oxygen. The measuring electrode also heats the skin being measured to facilitate maximal bloodflow to the area.

Outcome measures

Outcome measures
Measure	Subjects n=20 Participants patients were invited to participate one year after completing radiotherapy as part of their treatment for breast preservation cancer treatment
Tissue Oxygenation	62.5 mmHg Standard Deviation 18.4

SECONDARY outcome

Timeframe: One visit

Outcome measures

Outcome measures
Measure	Subjects n=20 Participants patients were invited to participate one year after completing radiotherapy as part of their treatment for breast preservation cancer treatment
Skin and Soft Tissue Toxicity Will be Assessed Using the RTOG/EORTC Late Radiation Morbidity Scoring Schema When Oxygenation is Measured. late subcutaneous toxicitiy score 1	19 Participants
Skin and Soft Tissue Toxicity Will be Assessed Using the RTOG/EORTC Late Radiation Morbidity Scoring Schema When Oxygenation is Measured. late subcutaneous toxcity score 2	1 Participants
Skin and Soft Tissue Toxicity Will be Assessed Using the RTOG/EORTC Late Radiation Morbidity Scoring Schema When Oxygenation is Measured. late skin toxicity score 1	19 Participants
Skin and Soft Tissue Toxicity Will be Assessed Using the RTOG/EORTC Late Radiation Morbidity Scoring Schema When Oxygenation is Measured. late skin toxicity score 2	1 Participants

Adverse Events

Subjects

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

Ken Dornfeld

Essentia Health

Phone: 218 786-1311

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place