Leal, A.D., Qin, R., Atherton, P.J., Haluska, P., Behrens, R.J., Tiber, C.H., . . . Loprinzi, C.L. (2014). North Central Cancer Treatment Group/Alliance trial N08CA-the use of glutathione for prevention of paclitaxel/carboplatin-induced peripheral neuropathy: A phase 3 randomized, double-blind, placebo-controlled study. Cancer, 120, 1890–1897. 

DOI Link

Study Purpose

To determine the effectiveness of glutathione for the prevention of taxol/carboplatin-induced peripheral neuropathy

Intervention Characteristics/Basic Study Process

One hundred eighty-five patients were randomized to receive either placebo or glutathione 1.5 mgm/m2 while receiving paclitaxel and carboplatin therapy over 15 minutes immediately before chemotherapy.

Sample Characteristics

  • N = 185  
  • MEDIAN AGE = 63 years
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Patients with ovarian cancer, lung cancer, or other
  • OTHER KEY SAMPLE CHARACTERISTICS: Some patients received weekly taxol, whereas others received taxol every three to four weeks. Patients with diabetes were also included.

Setting

  • SITE: Multi-site    
  • SETTING TYPE: Outpatient    
  • LOCATION: U.S. 

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Placebo-controlled, randomized, controlled trial

Measurement Instruments/Methods

  • European Organization for Research and Treatment of Cancer (EORTC) Quality of Life
  • Chemotherapy-induced peripheral neuropathy–specific sensory subscale
  • National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)
  • Functional Assessment of Cancer Therapy-Ovarian (FACT-O)

Results

No differences were reported in neurotoxic symptoms between the groups the week following taxol infusion. In addition, no differences were reported between the groups receiving taxol every three to four weeks. Time to development of at least grade 2 neurotoxicity was higher in the placebo group (p = 0.039).

Conclusions

The results indicated that this was a negative trial and do not support the use of glutathione for neurotoxic symptoms from taxol/carboplatin therapy.

Nursing Implications

The results of this negative trial showed that glutathione was not effective in patients receiving taxol/carboplatin. Very limited evidence supports effective interventions for preventing or minimizing chemotherapy-induced peripheral neuropathy. Ongoing research is needed in this area.