Breast Neoplasm FemaleNCT04047823
Temperature and Injury in Radiotherapy Radiation Skin Injury
An observational study of Breast Neoplasm Female and Radiation Toxicity, run by Shandong Cancer Hospital and Institute.
Trial summary
the main purpose of the present study was threefold: (1) to describe the thermographic response after radiation; (2) to investigate whether there was a significant temperature change over time and among the different radiation-dermatitis score; and (3) to test if temperature change could be used to predict the… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm Female, Radiation Toxicity
- What is being tested?
- a digital Infrared thermography (FLIR E5 Serial No.63985976）
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 2 Oct 2016to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients with a pathologically proven breast cancer receiving three dimensional conformal radiated therapy followed by modified radical mastectomy were eligible for the study. Other inclusion criteria included: age ≥18 years, ECOG PS≤1, normal organ function, no prior radiotherapy, and no concurrent chemotherapy. Exclusion criteria were as follows: rash or unhealed wound in the radiation field, pregnancy or lactation, and the presence of connective tissue disorder. All the enrolled were giving informed consent.
Who may be able to join
- a pathologically proven breast cancer receiving three dimensional conformal radiated therapy followed by modified radical mastectomy
- ECOG PS≤1
- normal organ function
- no prior radiotherapy
- no concurrent chemotherapy
Who cannot join
- rash or unhealed wound in the radiation field,
- pregnancy or lactation
- the presence of connective tissue disorder
About this study
Official title: Relationships Between the Changes of Skin Temperature and Radiation Skin Injury
the main purpose of the present study was threefold: (1) to describe the thermographic response after radiation; (2) to investigate whether there was a significant temperature change over time and among the different radiation-dermatitis score; and (3) to test if temperature change could be used to predict the development of radiation-induced skin injury in the incipient stage.
Read the detailed description
Radiation skin injury (RSI) is a frequent adverse reaction reported encountered by patients undergoing radiotherapy, occurring in about 87%-95% of irradiated patients and is characterized by swelling, redness, pigmentation, ulceration, fibrosis, pain, warmth, burning and itching of the skin. RSI has an effect on the level of discomfort experienced and the quality of life of patients, and may require interfering with radiation schedule and complex surgical reconstruction especially when combined with molecular targeted therapy. However, evaluation of RSI is not straightforward. There is no standard instrument for objective clinical evaluation of the severity of radiation skin injury.
Previous studies have shown that radiation leads to the development of cutaneous vasculature and generation of an inflammatory response, which will increased skin temperature. The skin temperature change due to laser or thermal injury has been measured in many studies with temperature and time as predictors of skin damage.
The most frequent method of skin temperature measurement has been the Infrared thermography. Consequently, the changes in the difference of skin temperature (DST) may be used as an objective, quantitative, and functional surrogate measure to determine and predict RSI.
- Conditions
- Breast Neoplasm Female, Radiation Toxicity
- Being tested
- a digital Infrared thermography (FLIR E5 Serial No.63985976）
- Medical subject headings
- Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a digital Infrared thermography (FLIR E5 Serial No.63985976）Device
Measurements were taken during radiation and additionally two weeks after radiotherapy weekly. Temperature change was measured by thermal infrared imager (FLIR) for 4 test areas within the supraclavicular radiation field and on an opposite non-irradiated area, which was outlined using a specific software package (FLIR Systems 6.3.17227.1001).
What is being measured
The primary outcome is the main question the study is designed to answer.
Thermographic response after radiation
Thermographic change were tested during radiation weekly
Measured: during the radiotherapy
temperature changes among the different radiation-dermatitis score
temperature changes among the different radiation-dermatitis score acoording to RTOG score
Measured: during the radiotherapy
temperature changes could be used to predict the development of dermatits in the incipient stage
Multiple linear regression analysis was performed to study the influence of various facters on severe dermatits.
Measured: during the radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start2 Oct 2016
- Primary completion31 Dec 2020 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Neoplasm FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Xi Zhao, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04047823
- Sponsor's protocol ID
- FIR-2015
- Status last verified
- Aug 2019
- First submitted
- 5 Aug 2019
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationships Between the Changes of Skin Temperature and Radiation Skin Injury
- ClinicalTrials.gov ID
- NCT04047823
- Acronym / sponsor ID
- FIR-2015
- Conditions
- Breast Neoplasm Female, Radiation Toxicity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- 2 Oct 2016 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 7 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
the main purpose of the present study was threefold: (1) to describe the thermographic response after radiation; (2) to investigate whether there was a significant temperature change over time and among the different radiation-dermatitis score; and (3) to test if temperature change could be used to predict the development of radiation-induced skin injury in the incipient stage.
Detailed description
Radiation skin injury (RSI) is a frequent adverse reaction reported encountered by patients undergoing radiotherapy, occurring in about 87%-95% of irradiated patients and is characterized by swelling, redness, pigmentation, ulceration, fibrosis, pain, warmth, burning and itching of the skin. RSI has an effect on the level of discomfort experienced and the quality of life of patients, and may require interfering with radiation schedule and complex surgical reconstruction especially when combined with molecular targeted therapy. However, evaluation of RSI is not straightforward. There is no standard instrument for objective clinical evaluation of the severity of radiation skin injury.
Previous studies have shown that radiation leads to the development of cutaneous vasculature and generation of an inflammatory response, which will increased skin temperature. The skin temperature change due to laser or thermal injury has been measured in many studies with temperature and time as predictors of skin damage.
The most frequent method of skin temperature measurement has been the Infrared thermography. Consequently, the changes in the difference of skin temperature (DST) may be used as an objective, quantitative, and functional surrogate measure to determine and predict RSI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients with a pathologically proven breast cancer receiving three dimensional conformal radiated therapy followed by modified radical mastectomy were eligible for the study. Other inclusion criteria included: age ≥18 years, ECOG PS≤1, normal organ function, no prior radiotherapy, and no concurrent chemotherapy. Exclusion criteria were as follows: rash or unhealed wound in the radiation field, pregnancy or lactation, and the presence of connective tissue disorder. All the enrolled were giving informed consent.
Key inclusion criteria (5 listed)
- a pathologically proven breast cancer receiving three dimensional conformal radiated therapy followed by modified radical mastectomy
- ECOG PS≤1
- normal organ function
- no prior radiotherapy
- no concurrent chemotherapy
Key exclusion criteria (3 listed)
- rash or unhealed wound in the radiation field,
- pregnancy or lactation
- the presence of connective tissue disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a digital Infrared thermography (FLIR E5 Serial No.63985976）Measurements were taken during radiation and additionally two weeks after radiotherapy weekly. Temperature change was measured by thermal infrared imager (FLIR) for 4 test areas within the supraclavicular radiation field and on an opposite non-irradiated area, which was outlined using a specific software package (FLIR Systems 6.3.17227.1001). | Device | – |
Primary outcome
Thermographic response after radiation
Time frame: during the radiotherapy
Thermographic change were tested during radiation weekly
temperature changes among the different radiation-dermatitis score
Time frame: during the radiotherapy
temperature changes among the different radiation-dermatitis score acoording to RTOG score
temperature changes could be used to predict the development of dermatits in the incipient stage
Time frame: during the radiotherapy
Multiple linear regression analysis was performed to study the influence of various facters on severe dermatits.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasm Female and Radiation Toxicity, run by Shandong Cancer Hospital and Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thermographic response after radiation (time frame: during the radiotherapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2019.