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  4. Effects of Dimethyl Fumarate on the Karnofsky Performance Status and Serum S100β Level in Newly Glioblastoma Patients: A Randomized, Phase-II, Placebo, Triple Blinded, Controlled Trial

Effects of Dimethyl Fumarate on the Karnofsky Performance Status and Serum S100β Level in Newly Glioblastoma Patients: A Randomized, Phase-II, Placebo, Triple Blinded, Controlled Trial

GMJ, 2022 · DOI: 10.31661/gmj.v11i0.1897 · Published: April 24, 2022

OncologyPharmacologySurgery

Simple Explanation

Glioblastoma (GBM) is a common and aggressive brain cancer with limited treatment options. This study explores whether dimethyl fumarate (DMF), a drug with anti-inflammatory and neuroprotective properties, can improve outcomes for GBM patients undergoing surgery. The trial involved 36 GBM patients who received either DMF or a placebo before and after surgery, along with standard treatments like radiotherapy and chemotherapy. The study measured Karnofsky Performance Status (KPS) scores (a measure of functional ability) and serum S100β levels (an indicator of brain injury). The study found that while DMF did not significantly affect serum S100β levels, it was associated with higher KPS scores after surgery compared to the placebo group. This suggests DMF may have a positive impact on patients' functional status following GBM surgery.

Study Duration
40 months
Participants
36 patients with a diagnosis of GBM
Evidence Level
Level II, Randomized, Phase-II, Placebo, Triple Blinded, Controlled Trial

Key Findings

  • 1
    DMF administration was associated with a statistically significant increase in KPS scores one month after surgery compared to the control group (P=0.001).
  • 2
    There was no statistically significant difference in serum S100β levels between the DMF and control groups before or after surgery (P>0.05).
  • 3
    Headache was the most common adverse event reported in both groups, and the frequency of adverse events was not significantly different between the groups (P=0.95), suggesting that DMF is relatively safe.

Research Summary

This phase II randomized controlled trial investigated the effects of dimethyl fumarate (DMF) on Karnofsky Performance Status (KPS) and serum S100β levels in newly diagnosed glioblastoma (GBM) patients undergoing surgery. The study found a statistically significant improvement in KPS scores in the DMF group compared to the placebo group one month after surgery, suggesting a potential benefit of DMF on functional status. However, DMF did not significantly affect serum S100β levels, and the study acknowledges limitations such as a short DMF administration period and follow-up, calling for further research with larger sample sizes and longer durations to assess overall survival and disease progression.

Practical Implications

Potential Adjunct Therapy

DMF may be considered as an adjunct therapy to standard treatment for GBM, potentially improving patients' functional status post-surgery.

Further Research Needed

Larger, longer-term studies are warranted to confirm the efficacy of DMF, evaluate its impact on overall survival and disease progression, and explore its mechanisms of action.

Patient Selection

Given the cost and potential limited efficacy of DMF, it may be most appropriate for select patients with poor prognoses who may benefit from short-term improvements in functional status.

Study Limitations

  • 1
    Short DMF administration period
  • 2
    Short follow-up duration
  • 3
    Lack of evaluation of overall and progression-free survival

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