Photobiomodulation Therapy in the Prevention and Management of Radiotherapy-induced Vaginal Toxicity

Launched by JESSA HOSPITAL · Dec 6, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called photobiomodulation therapy (PBMT) to see if it can help women who experience vaginal issues after receiving radiotherapy for endometrial cancer. The goal is to find out if PBMT can reduce these problems, which can affect a woman's quality of life and sexual function. The study is currently recruiting participants who are 18 years or older, have been diagnosed with endometrial cancer, and are scheduled to receive certain types of radiotherapy.

To participate in the trial, women must be able to follow the study guidelines and provide written consent. However, some women may not be eligible if they have certain conditions, like having cancer that has spread, being pregnant, or having received previous pelvic radiotherapy. If eligible, participants can expect to receive the PBMT treatment during their radiotherapy sessions and will be monitored for any changes in their symptoms. This study aims not just to help individuals but also to improve overall care for women undergoing similar treatments in the future.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Diagnosed with endometrial cancer
• • Scheduled for external beam radiotherapy (EBRT), intracavitary brachytherapy (BT), or a combination
• • Age ≥ 18 years
• • Able to comply to the study protocol
• • Able to sign written informed consent
• Exclusion Criteria:
• • Metastatic disease
• • Pregnancy
• • Diagnosis of vaginal stenosis before radiotherapy (RT)
• • Previous pelvic tumor or pelvic RT
• • Interruption of RT for more than five sessions
• • Severe psychological disorder or dementia.
• • Inability to speak and understand Dutch
• • Substance abuse patients or patients with medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results as judged by the investigator
• • Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator