Alamdarsaravi, M., Ghajar, A., Noorbala, A.A., Arbabi, M., Emami, A., Shahei, F., . . . Akhondzadeh, S. (2017). Efficacy and safety of celecoxib monotherapy for mild to moderate depression in patients with colorectal cancer: A randomized double-blind, placebo controlled trial. Psychiatry Research, 255, 59–65.

DOI Link

Study Purpose

To assess the safety and efficacy of celecoxib single therapy on depressive symptoms of patients with colorectal cancer who underwent chemotherapy.

Intervention Characteristics/Basic Study Process

Parallel-group, randomized, double-blind, placebo-controlled trial, randomized to either 400 mg per day celecoxib or placebo for 6 weeks.

Sample Characteristics

  • N = 40
  • AGE: 18-65 years
  • MALES: 65% in celecoxib arm; 55% in placebo arm  
  • FEMALES: Not listed
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Stage I–IV colorectal cancer diagnosed more than 100 days 
  • OTHER KEY SAMPLE CHARACTERISTICS: 15% in celecoxib group and 20% in placebo group reported past psychiatry history

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Tehran University of Medical Sciences, Tehran, Iran

Phase of Care and Clinical Applications

PHASE OF CARE: Active anti-tumor treatment

Study Design

Parallel-group, randomized, double-blind, placebo-controlled trial

Measurement Instruments/Methods

Hamilton Depression Rating Scale, Visual Analog Scale to measure pain intensity, at week 2, 4, and 6 post-treatment. Adverse events were evaluated at each point using a checklist. Medication adherence was measured with weekly capsule counts with participant reports of medication intake.

Results

HRDS scores were significantly greater in the celecoxib treatment group at week 2 and remained higher until week 6 (p = 0.028). There was not a significant difference between mean VAS scores between the groups at week 2, 4, and 6 (p = 0.459). Gastrointestinal side effects that have been attributed to celecoxib, such as abdominal pain and diarrhea, were not significantly different between the intervention groups. No symptoms of cardiovascular adverse event or serious adverse event occurred.

Conclusions

Celecoxib monotherapy is potentially safe and effective treatment for mild to moderate depression in patients with colorectal cancer undergoing chemotherapy.

Limitations

Small sample (< 100)

Nursing Implications

Oncology nurses are in a key position to screen for psychological distress in patients undergoing chemotherapy. Celecoxib has been shown in this study to be effective for mild to moderate depression in patients with colorectal cancer. Celecoxib may also be effective in patients with other malignancies although further research is needed. Oncology nurses should discuss with physicians the use of celecoxib for any patients with colorectal cancer exhibiting mild to moderated depression as evidenced on psychological distress screening.