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New treatment option for Acute Radiation Dermatitis
Official title Bacterial Cellulose-monolaurin Hydrogel for Acute Radiation Dermatitis
ClinicalTrials.gov ID: NCT05079763
What this study is testing
- What it's testing
- Acute radiation dermatitis (ARD) is almost universally experienced by patients with cancer during or after radiation therapy. This condition potentially leads to detrimental clinical outcomes as it adversely affects adherence to prescribed subsequent management and further worsens quality of life.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80, women only
You may be able to join if
- Female sex at birth
- Age at least 18 years at the time of invitation
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of either 0 or 1
- With histopathologic diagnosis of breast carcinoma
- Already completed prescribed mastectomy and chemotherapy (adjuvant or neoadjuvant) interventions
You likely can't join if
- Pregnant or lactating
- With concurrent or previous history of any malignancy
- With history of mediastinal or thoracic irradiation
- With current bilateral synchronous breast carcinoma
- With diagnosis of metastases from any form of breast cancer
- With any skin lesion in the planned radiation field deemed deramtologically and/or radiotherapeutically relevant
See the full eligibility criteria
- Female sex at birth
- Age at least 18 years at the time of invitation
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of either 0 or 1
- With histopathologic diagnosis of breast carcinoma
- Already completed prescribed mastectomy and chemotherapy (adjuvant or neoadjuvant) interventions
- Scheduled to receive hypo fractionated postmastectomy-postchemotherapy radiation therapy
- Pregnant or lactating
- With concurrent or previous history of any malignancy
- With history of mediastinal or thoracic irradiation
- With current bilateral synchronous breast carcinoma
- With diagnosis of metastases from any form of breast cancer
- With any skin lesion in the planned radiation field deemed deramtologically and/or radiotherapeutically relevant
- With concomitant disease states deemed clinically significant (connective tissue diseases, infections, uncontrolled chronic disorders, renal failure, hepatic dysfunction, etc.)
- With known history of hypersensitivities and/or reactions against any component of either experimental or comparator interventions
- Inability to personally provide informed consent or to personally comply with skin care instructions
The study team makes the final eligibility decision.
Where it's taking place
- Manila, Philippines
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Manila, Philippines. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.