Protective Role of Alpha-Lipoic Acid in Chemotherapy-Induced Mucositis
Recruiting
Phase 2
Phase 3
Interventional Study
Colorectal Cancer
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 50 (estimated)
- Sponsor
- Ain Shams University · Other
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About This Trial
Colorectal cancer (CRC) represents one of the most common cancers worldwide and 5-Fluorouracil (5-FU) is still the mainstay of treatment. However, 5-FU is often implicated in inducing oral mucositis (OM), a painful inflammatory condition that may hinder oral intake, negatively impact quality of life and disrupt adherence with cancer treatment.
Oxidative stress and inflammation play a vital role i…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age \>18 years.
2. Newly diagnosed chemotherapy naive CRC patients
3. Planned to receive FOLFOX-6 protocol as adjuvant, neoadjuvant or palliative therapy.
4. Adequate liver function (liver transaminases level \< 3 times upper normal limits and total bilirubin \< 1.5 times upp…
Contacts