In short
This article discusses a clinical trial exploring the use of GR1014 cutaneous gel, containing the active substance Amifostine Thiol, as a potential treatment to prevent skin damage (radiodermatitis) caused by radiation therapy in breast cancer patients who have undergone lumpectomy. The study aims to assess the safety, tolerability, and effectiveness of this gel compared to a placebo in reducing the severity and occurrence of radiation-induced skin reactions.
At a glance
- Study Drug
- GR1014 Cutaneous Gel (containing Amifostine Thiol)
- Study Design
- Randomized, double-blind, vehicle-controlled, multi-centre, parallel-group
- Participant Profile
- Female patients ≥18 years with localized breast cancer after lumpectomy
- Radiation Therapy
- Ultra hypofractionated RT, 26 Gy in 5 fractions on whole breast
- Primary Outcome
- Percentage of participants with no radiation dermatitis
- Key Secondary Outcomes
- Severity of radiodermatitis, time to onset, duration, quality of life impact
- Safety Assessments
- Adverse events, vital signs, serum calcium levels, pharmacokinetics
- Treatment Duration
- 5 days of radiation therapy plus 4 weeks follow-up
What is Amifostine Thiol?
Amifostine Thiol, also known as GR1014 thiol or WR 1065 thiol, is an active substance being studied for its potential to protect the skin from damage caused by radiation therapy. It is being developed as a cutaneous gel (GR1014-CG) for topical application on the skin.
Medical Condition Treated
The primary medical condition being targeted by Amifostine Thiol is radiation-induced dermatitis, also known as radiodermatitis. This is a skin condition that occurs as a side effect of radiation therapy, often experienced by breast cancer patients undergoing treatment after lumpectomy (a surgery to remove a tumor from the breast).
How It Works
Amifostine Thiol is being investigated as a topical radioprotector. This means it's designed to protect healthy skin cells from the damaging effects of radiation therapy. When applied to the skin before radiation treatment, it may help prevent or reduce the severity of radiation-induced skin reactions.
Clinical Trial Details
A Phase II clinical trial, named GuARD (GR1014 cutaneous gel Against Radiation Dermatitis), is currently underway to investigate the safety, tolerability, and efficacy of GR1014-CG. This trial is specifically focusing on breast cancer patients who have undergone lumpectomy and require adjuvant radiotherapy.
Potential Benefits
The clinical trial aims to assess several potential benefits of Amifostine Thiol, including: Reducing the severity of radiodermatitis Delaying the onset of radiodermatitis Reducing the duration of radiodermatitis Reducing patient-reported pain and itching in the irradiated skin area Improving patients' quality of life during and after radiation therapy
Administration and Dosage
In the clinical trial, GR1014-CG is being applied topically to the skin area that will receive radiation therapy. The gel is applied at a dosage of 0.5 mL per 100 cm² of skin surface. The treatment is administered daily, coinciding with the radiation therapy sessions, which typically involve 5 fractions of radiation.
Eligibility Criteria
The clinical trial has specific eligibility criteria, including: Female patients aged 18 or older Diagnosed with primary, localized breast cancer without metastases Have undergone breast-conserving surgical excision (lumpectomy) Require adjuvant radiation therapy No signs of dermatitis in the breast area to be irradiated
Safety and Side Effects
As this is a Phase II clinical trial, one of the primary objectives is to assess the safety and tolerability of GR1014-CG. The trial includes a safety run-in period and ongoing monitoring for any adverse events. Patients with allergies to any ingredients in GR1014-CG are excluded from the trial. It's important to note that as this is an investigational treatment, all potential side effects may not yet be known.