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

NCT05165056 | Recruiting DMC

• 1 other identifier: 2021/099
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to investigate the effectiveness of photobiomodulation therapy (PBMT) in the prevention and management of radiotherapy-induced vaginal toxicity (RIVT). Therefore, we hypothesize that PBMT can reduce the severity of RIVT in gynecological cancer patients, increasing the patient's QoL and sexual functioning.

Conditions

Radiotherapy Side Effect; Vaginal Abnormality

Keywords

Photobiomodulation therapy

Outcome Measures

Primary Outcomes (8)

• CTCAE-score

  The physician will score the patient's vaginal dryness, discharge, inflammation, stricture, pain and hemorrhage according to the Common Terminology Criteria for Adverse Events (CTCAE)

  Baseline

• CTCAE-score

  The physician will score the patient's vaginal dryness, discharge, inflammation, stricture, pain and hemorrhage according to the Common Terminology Criteria for Adverse Events (CTCAE)

  Two weeks post radiotherapy

• CTCAE-score

  The physician will score the patient's vaginal dryness, discharge, inflammation, stricture, pain and hemorrhage according to the Common Terminology Criteria for Adverse Events (CTCAE)

  Three months post radiotherapy

• RIVT symptoms

  The patient will score their symptoms (dryness, pruritus, discharge, hemorrhage and a burning sensation) via a numeric rating scale (NRS) ranging from 0 (symptom absent) to 10 (most severe form).

  Baseline

• RIVT symptoms

  The patient will score their symptoms (dryness, pruritus, discharge, hemorrhage and a burning sensation) via a NRS ranging from 0 (symptom absent) to 10 (most severe form).

  Final radiotherapy session

• RIVT symptoms

  The patient will score their symptoms (dryness, pruritus, discharge, hemorrhage and a burning sensation) via a NRS ranging from 0 (symptom absent) to 10 (most severe form).

  Two weeks post radiotherapy

• RIVT symptoms

  The patient will score their symptoms (dryness, pruritus, discharge, hemorrhage and a burning sensation) via a NRS ranging from 0 (symptom absent) to 10 (most severe form).

  Three months post radiotherapy

• RIVT symptoms

  The patient will score their symptoms (dryness, pruritus, discharge, hemorrhage and a burning sensation) via a NRS ranging from 0 (symptom absent) to 10 (most severe form).

  One year post radiotherapy

Secondary Outcomes (22)

• Vaginal health index (VHI)

  Baseline

• Vaginal health index (VHI)

  Two weeks post radiotherapy

• Vaginal health index (VHI)

  Three months post radiotherapy

• Pain score

  Baseline

• Pain score

  Two weeks post radiotherapy

Other Outcomes (9)

• General patient-, disease-, and treatment-related information

  Baseline

• General patient-, disease-, and treatment-related information

  Three months post radiotherapy

• General patient-, disease-, and treatment-related information

  One year post radiotherapy

Study Arms (2)

Treatment group

EXPERIMENTAL

Patients allocated to the treatment group will receive institutional standard vaginal care in combined with twice weekly PBMT sessions during the radiotherapy course and until two weeks after the end of radiotherapy.

Device: Intimleds

Control group

NO INTERVENTION

Patients allocated to the control group will receive institutional standard vaginal care.

Interventions

Intimleds DEVICE

INTIMILEDS® is a photobiomodulation device designed for intravaginal use. It's design permits an irradiation of the whole vaginal wall, the vulva, and the cervix, with a constant intensity.

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jessa Hospital: lead
• Ziekenhuis Oost-Limburg: collaborator
• Hasselt University: collaborator

Study Sites (2)

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

RECRUITING

Jessa Hospital

Hasselt, Limburg, 3500, Belgium

RECRUITING

MeSH Terms

Conditions

Radiation Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Jeroen Mebis, Prof. Dr.

  Jessa Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeroen Mebis, Prof. Dr.

CONTACT

+32 11 33 72 21; jeroen.mebis@jessazh.be

Marithé Claes, MSc

CONTACT

+32 11 33 72 39; marithe.claes@uhasselt.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 21, 2021
• Study Start: August 24, 2022
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: September 29, 2023

Record last verified: 2023-09

Locations

BE (2)