Effectiveness Not Established

Alpha Lipoic Acid

for Peripheral Neuropathy

Alpha-lipoic acid is an antioxidant that has been examined for the treatment of diabetic neuropathy. Oral alpha-lipoic acid was studied for its effect on chemotherapy-induced peripheral neuropathy.

Research Evidence Summaries

Guo, Y., Jones, D., Palmer, J.L., Forman, A., Dakhil, S.R., Velasco, M.R., . . . Fisch, M.J. (2014). Oral alpha-lipoic acid to prevent chemotherapy-induced peripheral neuropathy: A randomized, double-blind, placebo-controlled trial. Supportive Care in Cancer, 22, 1223–1231.

Study Purpose

To test whether oral alpha-lipoic acid (ALA) could reduce the severity of peripheral neuropathy in patients receiving platinum-based chemotherapy

Intervention Characteristics/Basic Study Process

Prior to randomization, patients were stratified according to prior exposure to platinum-based therapy dosages. Patients were assigned to receive ALA 600 mg oral sustained-release tablets three times per day. Control patients received a matching placebo. Medications were taken continuously for 24 weeks between two days prior and four days after each dose of platinum.

Sample Characteristics

  • N = 70   
  • MEAN AGE = 56 years
  • MALES: 53%, FEMALES: 47%
  • KEY DISEASE CHARACTERISTICS: Gastrointestinal cancers were most common. Dosage of platinum compounds were in excess of 750 mg/m2​.
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients with neuropathy and diabetes mellitus, and those exposed to carboplatin, vincristine, paclitaxel, or docetaxel within the past six months were excluded.

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Outpatient   
  • LOCATION: Texas

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Double-blind, placebo-controlled RCT

Measurement Instruments/Methods

  • FACT/GOG-NTX (version 4) for neuropathic symptoms
  • Brief Pain Inventory
  • Functional tests—time to button a six-button shirt, 50-foot walk, and coin test

Results

Only 28% in the ALA arm and 30% in the placebo arm completed 24 weeks of the study. Most discontinued the study because of withdrawal of consent and noncompliance. Neuropathy scores increased significantly from baseline in both groups at 24 weeks (p < .001). No differences were observed in study results between groups.  Authors state that attrition was not related to toxicities and that adverse events were comparable between groups.

Conclusions

Findings did not show a beneficial effect of ALA for prevention or reduction of peripheral neuropathy in patients receiving platinum-based chemotherapy.

Limitations

  • Small sample (less than 100)
  • Subject withdrawals 10% or greater
  • Other limitations/explanation: Extensive attrition, suggesting that the intervention was not acceptable to patients

Nursing Implications

Findings do not show a benefit of oral ALA for prevention of chemotherapy-induced peripheral neuropathy with platinum-based chemotherapy. Management and prevention of chemotherapy-induced peripheral neuropathy is a challenge that is generally managed by dose reduction or chemotherapy discontinuation, which can reduce effectiveness in treatment of cancer. Few approaches have shown to be effective in preventing or reducing chemotherapy-induced peripheral neuropathy. Ongoing research in this area is needed.

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