Ongoing Clinical Trials for Radiation Skin Injury

Currently, there is one ongoing clinical trial investigating treatments for radiation skin injury. This trial is being conducted in France and focuses on preventing skin damage in breast cancer patients receiving radiation therapy after surgery. The study is testing a protective gel called GR1014 that may help shield the skin from radiation-related damage.

Clinical trial locations

• France
  • Study on GR1014 Gel to Prevent Skin Damage from Radiation in Breast Cancer Patients After Lumpectomy

Study on GR1014 Gel to Prevent Skin Damage from Radiation in Breast Cancer Patients After Lumpectomy

This clinical trial is investigating whether a specially formulated gel can protect the skin from damage during radiation therapy. The trial is specifically designed for women who have undergone breast-conserving surgery for localized breast cancer and need additional radiation treatment.

Main inclusion criteria:

• Women aged 18 years or older
• Diagnosis of primary, localized breast cancer that has not spread to other parts of the body
• Previous breast-conserving surgery with a need for radiation therapy
• If chemotherapy was received, joining within 4 weeks of the last session; if no chemotherapy, joining within 8 weeks after surgery
• Scheduled to receive a specific type of radiation therapy involving 26 Gy delivered in 5 sessions to the whole breast
• No existing signs of skin irritation or damage in the breast area to be treated
• Ability to perform daily activities with little or no limitations
• Women of childbearing potential must use highly effective birth control during the study and for 6 months afterward

Main exclusion criteria:

• Male patients
• Existing radiation-induced skin damage or dermatitis
• Patients considered part of vulnerable populations requiring special protection

Focus and goal of the trial:

The main purpose of this study is to test whether GR1014 Cutaneous Gel can prevent or reduce the severity of radiation-induced skin damage compared to a placebo gel. This condition, known as radiation-induced dermatitis or radiodermatitis, is a common side effect of radiation therapy that can cause redness, dryness, itching, peeling, and in severe cases, blistering and open sores on the skin.

The trial follows a double-blind design, meaning neither the participants nor the researchers will know who is receiving the active gel or the placebo until the study is completed. This approach helps ensure that the results are objective and unbiased.

Participants will apply the gel to the skin area receiving radiation treatment before each radiation session. Their skin condition will be carefully monitored throughout the treatment period and for four weeks after the final radiation session. Medical professionals will assess any changes in skin condition and document any side effects experienced by participants.

Investigational drug:

The study is testing GR1014 Cutaneous Gel, which contains an active ingredient called amifostine thiol. This gel is applied directly to the skin and is being investigated for its ability to protect skin cells from the harmful effects of radiation. The gel works as a radioprotector, potentially shielding the skin from damage during radiation therapy. While the exact mechanism is still under investigation, the goal is to determine whether this topical treatment can effectively prevent or minimize radiation-related skin injury.

Summary

Currently, only one clinical trial is actively recruiting patients for radiation skin injury, specifically focusing on prevention rather than treatment of existing damage. This trial is being conducted in France and targets a specific patient population: women with localized breast cancer who have undergone breast-conserving surgery and require radiation therapy.

The trial takes a preventive approach by testing a protective gel that is applied before radiation sessions. The focus on GR1014 Cutaneous Gel represents an investigational effort to address a common and often uncomfortable side effect of radiation therapy. The study design includes careful monitoring of participants throughout their radiation treatment and follow-up period to assess both the effectiveness and safety of this preventive approach.

Patients interested in participating should meet the specific eligibility criteria and be prepared to commit to the full duration of the study, including follow-up visits after radiation therapy is completed.