None listed
Conditions
Brief summary
With recent advances in radiation therapy, non-melanoma skin cancer of the legs may be treated using volumetric modulated arc therapy (VMAT). The purpose of this study is to monitor swelling during and following VMAT treatment. Who is it for? You may be eligible for this study if you are aged 50 years or above, have symptomatic extensive skin field cancerisation, and are undergoing VMAT radiation therapy. Study details All participants in this study will continue to receive VMAT radiation therapy as per routine clinical care. Participants will undergo two indocyanine green lymphography scans which will be used to map the lymphatics. These scans will be done prior to commencing radiation therapy and six months after completing radiation therapy. Additionally participants will have their legs measured (using a tape measure), bioimpedance spectroscopy (BIS) measurements using the SOZO® ImpediMed, Australia) device, and fill in questionnaire/s weekly during their radiation therapy then at 1,2 and 6 weeks, and 3- and 6-months post completion of radiation therapy. BIS a non-invasive, pain free method of measuring fluid levels and body composition. All additional study assessments except for the ICG lymphography scans will be completed when the participant attends for clinical review. It is hoped that this research will reveal factors that influence swelling during VMAT treatment and improve understanding of radiation therapy for treating non-melanoma skin cancer.
Interventions
This study is an observational study which aims to utilise validated assessment tools for patients undergoing VMAT radiation for skin field cancerisation of the lower limbs to explore factors which may impact oedema and lymphatic drainage. Assessments include medical history, circumferential limb measures, cone beam computed tomography (CBCT) volume measures, radiation dosimetry, bioimpedance spectroscopy, indocyanine green (ICG) lymphography and patient reported outcome surveys. Participants w
This study is an observational study which aims to utilise validated assessment tools for patients undergoing VMAT radiation for skin field cancerisation of the lower limbs to explore factors which may impact oedema and lymphatic drainage. Assessments include medical history, circumferential limb measures, cone beam computed tomography (CBCT) volume measures, radiation dosimetry, bioimpedance spectroscopy, indocyanine green (ICG) lymphography and patient reported outcome surveys. Participants will attend 2 ICG lymphography scans pre radiation therapy and 6 months after completing radiation therapy which will take approximately one hour. During treatment the participants will be seen after their radiation therapy weekly for circumferential and bioimpedance spectroscopy measures and to complete patient reported outcome surveys which will take approximately half an hour. After treatment is completed the participants will be seen for the same measures and surveys one, two and six weeks, and three and six months post treatment after consultation with their radiation oncologist.
Sponsors
Cancer Care Research Pty Limited
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Be aged 50 years or older 2. Have symptomatic extensive skin field cancerisation (ESFC) greater than 50cm2 3. Be undergoing wide field (>50cm2), VMAT radiation therapy to the lower limb at GenesisCare trial sites in NSW. 4. Understand and have provide written informed consent for participation in this trial.
Exclusion criteria
1. Have received prior VMAT wide field radiotherapy (>50cm2 ) to either leg. 2. History of lymphoedema in either lower limb 3. Lower limb peripheral vascular intervention prior to radiation therapy 4. Cardiac pacemaker or Implantable Cardioverter Defibrillator (ICD) 5. Allergy to shellfish or iodine 6. Any other condition/factor as defined by the investigator which significantly impact the patient’s involvement and suitability in this study
Outcome results
None listed