Breast Neoplasms, Radiation Tolerance
Conditions
Brief summary
Non-randomized clinical cohort study investigating if single nucleotide polymorphism (SNP) or inflammatory markers can predict radiosensitivity in breast cancer patients receiving radiotherapy.
Detailed description
Objectives 1. To explore if acute radiation response can be predicted in patients, by analyzing a single nucleotide polymorphism (SNP rs1801516) sampled prior to radiotherapy. 2. If acute radiation response can be predicted in patients, by analyzing genetic and inflammatory markers in blood sampled prior to radiotherapy. 3. If late side effects from radiotherapy can be predicted in patients, by analyzing genetic and inflammatory markers in blood sampled before and after radiotherapy. 4. If there is a correlation between genetic and inflammatory markers in blood and patient reported outcome measures (PROM) and quality of life (QoL). 5. To train an algorithm to correlate the appearance of skin before radiotherapy and the extent of skin reaction to radiotherapy Outline This study is a non-randomized clinical cohort study. Adults with breast cancer will be invited to participate in the study. Blood will be collected before start of treatment and after radiotherapy is completed. Quality of life (QoL) and symptoms will be assessed before and weekly during treatment, at the end of treatment and after one year. A total of 550 patients is expected to be recruited.
Interventions
RADIATIONBlood sample
Blood sample before and after radiotherapy and photography before radiotherapy
Sponsors
Stockholm University
Karolinska University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients receiving adjuvant radiotherapy for breast cancer 2,67 Gy x 15 (or a radio biologically equivalent dose) * \> 18 years * Being able to read and understand patient information in Swedish * Signed informed consent
Exclusion criteria
* Ongoing infection * Fever \>37,9 degrees Celsius * Unable to follow study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute radiation dermatitis grading criteria | Before and during treatment and after one year | Acute radiation dermatitis grading criteria according to the Radiation Therapy Oncology Group. Minimum value 1 and maximum value 4, higher value means a worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life (QoL) | Before and during treatment and after one year | Quality of life determined by European Organisation for Research and Treatment of Cancer questionnaire QLQ-C30 |
| Breast cancer specific Quality of life (QoL) | Before and during treatment and after one year | Quality of life determined by European Organisation for Research and Treatment of Cancer questionnaire QLQ-BR23 |
| Cancer related fatigue Quality of life (QoL) | Before and during treatment and after one year | Quality of life determined by European Organisation for Research and Treatment of Cancer questionnaire QLQ-FA12 |
| Number of participants with heart disease | at five years | Heart disease as described in patient chart diagnosed after radiotherapy |
| Number of participants with lung disease | at five years | Lung disease as described in patient chart diagnosed after radiotherapy and related to the radiotherapy treatment area |
Countries
Sweden
Contacts
Primary ContactMattias Hedman, MD PhD
Outcome results
None listed