Bruera, E., Roca, E., Cedaro, L., Carraro, S., & Chacon, R. (1985). Action of oral methylprednisolone in terminal cancer patients: A prospective randomized double-blind study. Cancer Treatment Reports, 69, 751–754.

DOI Link

Study Purpose

To compare the effectiveness of oral methylprednisolone against placebo for relief of symptoms in patients with terminal cancer (pain, psychiatric status, appetite, nutritional status, and daily activity)

Intervention Characteristics/Basic Study Process

Participants were randomized to two groups, one receiving a placebo and the other receiving oral methylprednisolone (MP).

  • Days 0–4: Participants received 16 mg of of oral MP or the placebo.
  • Days 5–7: No treatment was given.
  • Day 8: Crossover
  • Days 8–12: Participants received oral MP versus placebo.
  • Day 13: The double-blind was completed, then all participants received 32 mg of oral MP daily for 20 days.

Participants were evaluated in in the morning on days 0, 5, 13, and 33.

Sample Characteristics

  • The study reported on a sample of 40 patients.
  • Patients were included if they were terminally ill with cancer, had not received anticancer therapy for four weeks prior to the study, and were not on medication except for analgesic mediation (propoxyphene compound).
  • Patients were excluded if they had diabetes, infection, history of peptic ulcer disease, or severe psychiatric disturbances.

Study Design

A randomized, double-blind, crossover trial design was used.

Measurement Instruments/Methods

The following symptoms were measured.

  • Pain
  • Psychological status: Hamilton Rating Scales for depression (HAM-D) and anxiety (HAM-A) were used.
  • Appetite: The mean amount of food eaten was measured. Patients evaluated themselves using a visual analog scale (VAS).
  • Nutritional status: Daily weight, skinfold measurement, and serum albumin levels were monitored. 
  • Activity: An interview was conducted with the nurse, participant, and family regarding the participant's ability to perform and engage in activities of daily living (ADL).

Results

At the completion of the study, 31 participants were evaluated. They showed significant improvement in pain, depression, appetite, and food consumption. No improvement was noted in anxiety or performance status. 

No change in nutritional status was observed in either arm of the study. All parameters sensitive to MP reached maximum improvement during the first phase of the study. Eight of 23 participants who initially responded to MP were not experiencing symptomatic benefit from the drug by day 33.

Conclusions

The study suggested that short courses of corticosteroids can be given to severely symptomatic patients with advanced cancer who have no major contraindications.

Limitations

  • The study had a small sample size, but looked at a wide variety of symptoms experienced by patients with cancer at the end of life, not just appetite and food intake.
  • The corticosteroids had side effects of cushingoid features, increased anxiety, and mild fluid retention.