Hovey, E., de Souza, P., Marx, G., Parente, P., Rapke, T., Hill, A., . . . Lloyd, A. (2014). Phase III, randomized, double-blind, placebo-controlled study of modafinil for fatigue in patients treated with docetaxel-based chemotherapy. Supportive Care in Cancer, 22, 1233-1242. 

DOI Link

Study Purpose

To determine whether modafinil could reduce fatigue related to docetaxel chemotherapy

Intervention Characteristics/Basic Study Process

Patients with metastatic breast or prostate cancer receiving docetaxel chemotherapy and experiencing significant fatigue were randomized to receive modafinil or placebo for 15 days beginning with their third cycle of treatment and repeated for 2–4 subsequent chemotherapy cycles.

Sample Characteristics

  • N = 83  
  • MEAN AGE = 66.4 years in the modafinil group and 68 years in the placebo group
  • MALES: 78%, FEMALES: 22%
  • KEY DISEASE CHARACTERISTICS: Primarily Caucasian; metastatic breast/prostate cancer; received at least two cycles of docetaxel; MDASI fatigue score (≥ 4/10); Hgb ≥ 10

Setting

  • SITE: Multi-site  
  • SETTING TYPE: Not specified  
  • LOCATION: Australia

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active anti-tumor treatment

Study Design

  • Phase II randomized, double-blind, placebo-controlled.
  • Eligible patients were randomized 2:1 to modafinil or placebo and stratified according to tumor type.

Measurement Instruments/Methods

  • MD Anderson Symptom Inventory (MDASI)
  • Secondary outcomes measures included depression, sleep disturbance, exercise, cognition, and mood states.

Results

The goal was a 10% or greater relative difference between the two treatment groups.

Conclusions

The primary endpoint of reduced fatigue during docetaxel chemotherapy was not statistically different between the two treatment arms.

Limitations

  • Small sample (< 100)
  • Key sample group differences that could influence results
  • Measurement validity/reliability questionable
  • Questionable protocol fidelity
  • Other limitations/explanation: Study had to be repowered due to limited recruitment. Unclear how secondary measures were evaluated. Use of dexamethasone premedication.

Nursing Implications

Features a trend in docetaxel-related fatigue. Effectiveness was not established for the broader cancer-related fatigue treatment.