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Amifostine Thiol

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.

Table of Contents

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[1]. It is being developed as a cutaneous gel (GR1014-CG) for topical application on the skin[1].

Medical Condition Treated

The primary medical condition being targeted by Amifostine Thiol is radiation-induced dermatitis, also known as radiodermatitis[1]. 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)[1].

How It Works

Amifostine Thiol is being investigated as a topical radioprotector[1]. 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[1]. This trial is specifically focusing on breast cancer patients who have undergone lumpectomy and require adjuvant radiotherapy[1].

Potential Benefits

The clinical trial aims to assess several potential benefits of Amifostine Thiol, including:

  • Reducing the severity of radiodermatitis[1]
  • Delaying the onset of radiodermatitis[1]
  • Reducing the duration of radiodermatitis[1]
  • Reducing patient-reported pain and itching in the irradiated skin area[1]
  • Improving patients’ quality of life during and after radiation therapy[1]

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[1]. The treatment is administered daily, coinciding with the radiation therapy sessions, which typically involve 5 fractions of radiation[1].

Eligibility Criteria

The clinical trial has specific eligibility criteria, including:

  • Female patients aged 18 or older[1]
  • Diagnosed with primary, localized breast cancer without metastases[1]
  • Have undergone breast-conserving surgical excision (lumpectomy)[1]
  • Require adjuvant radiation therapy[1]
  • No signs of dermatitis in the breast area to be irradiated[1]

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[1]. The trial includes a safety run-in period and ongoing monitoring for any adverse events[1]. Patients with allergies to any ingredients in GR1014-CG are excluded from the trial[1]. It’s important to note that as this is an investigational treatment, all potential side effects may not yet be known.

Aspect Details
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

FAQ

  • What is the main purpose of this clinical trial? The main purpose of this clinical trial is to investigate the safety, tolerability, and efficacy of GR1014 cutaneous gel as a treatment to prevent radiodermatitis in breast cancer patients receiving radiation therapy after lumpectomy.
  • Who can participate in this study? The study is open to female patients aged 18 or older with primary, localized breast cancer without metastases, who have undergone breast-conserving surgery and require adjuvant radiation therapy. Participants must have no signs of dermatitis in the breast area to be irradiated and be able to comply with the study requirements.
  • How is the gel applied during the trial? The gel (either GR1014-CG or placebo) is applied topically to the skin surface that will be irradiated. The dosage is 0.5 mL per 100 square centimeters of skin.
  • What are the main outcomes the researchers are looking at? The primary outcome is the percentage of participants who do not develop radiation dermatitis between the first radiation therapy session and 4 weeks after the last one. Secondary outcomes include the severity of radiodermatitis, time to onset, duration, and impact on quality of life.
  • How long does the treatment last? The treatment with GR1014 cutaneous gel or placebo is applied during the course of radiation therapy, which consists of 5 fractions (sessions) of radiation. The study also includes a follow-up period of 4 weeks after the last radiation therapy session.

Ongoing Clinical Trials on Amifostine Thiol

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

    Not recruiting

    1
    Investigated drugs:
    France

Glossary

  • Radiodermatitis: Skin inflammation or damage caused by exposure to radiation therapy. It can range from mild redness to severe skin breakdown.
  • Lumpectomy: A surgical procedure that removes a tumor and a small amount of surrounding tissue from the breast, while preserving most of the breast tissue.
  • Adjuvant radiotherapy: Radiation treatment given after surgery to reduce the risk of cancer recurrence.
  • Ultra hypofractionated RT: A type of radiation therapy that delivers higher doses of radiation over fewer treatment sessions compared to standard radiation therapy.
  • CTCAE: Common Terminology Criteria for Adverse Events, a standardized system for grading the severity of side effects in cancer treatment.
  • Amifostine Thiol: The active substance in GR1014 cutaneous gel, which is being studied for its potential to protect skin from radiation damage.
  • Double-blind: A study design where neither the participants nor the researchers directly involved know who is receiving the active treatment or placebo.
  • Placebo: A substance that looks identical to the study drug but contains no active ingredient, used to compare the effects of the active treatment.
  • Transepidermal water loss (TEWL): A measurement of how much water passes from inside the body through the skin and evaporates, used to assess skin barrier function.

References

  1. http://clinicaltrials.eu/trial/study-on-gr1014-gel-to-prevent-skin-damage-from-radiation-in-breast-cancer-patients-after-lumpectomy/