Jatoi, A., Windschitl, H.E., Loprinzi, C.L., Sloan, J.A., Dakhil, S.R., Mailliard, J.A., . . . Christensen, B. (2002). Dronabinol versus megestrol acetate versus combination therapy for cancer associated anorexia: A North Central Cancer Treatment Group study. Journal of Clinical Oncology, 20, 567–573.

To evaluate the efficacy of megestrol acetate versus dronabinol, as well as a combination of these treatments

This was a randomized, controlled, three-arm trial using a double-blind procedure. The first arm evaluated the efficacy of 800 mg/day of oral megestrol acetate plus a capsule placebo; the second arm evaluated the efficacy of 2.5 mg of oral dronabinol twice daily plus a liquid placebo; and the third arm combined both medications. Evaluations were taken at noted doses.

The final sample included 469 patients. The sample was stratified for confounding factors, including age, gender, cancer type, estimate of survival, performance status, severity of weight loss, concomitant radiation therapy, treatment center, and planned or ongoing treatment. Sample size calculations included a power analysis and accounted for attrition.

All participants shared the following characteristics:

• Adults with an incurable malignancy, with the exception of brain, breast, ovarian, and endometrial cancers 
• An estimated life expectancy of three months or more, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0–2 
• A self-reported weight loss of at least five pounds and/or physician-estimated caloric intake of 20 or fewer calories/kg of body weight/day.

North Central Cancer Treatment Group (NCCTG) trial involving 20 NCCTG institutions, including the Mayo Clinic

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

• Weight was measured using home scales and office scales.
• Anorexia was assessed using validated NCCTG questionnaires.
• Quality of life was assessed using a single-item Uniscale and a 13-item, anorexia-specific Functional Assessment of Anorexia/Cachexia Cancer Therapy (FAACT) instrument. The validity and reliability of these instruments was previously reported.

No differences between groups at baseline were noted. A greater percentage of patients treated with megestrol acetate reported appetite improvement (75% versus 49%; p = 0.0001) and baseline weight gain (11% versus 3%, p = 0.02) for ≥ 10%) compared with dronabinol-treated patients. Combination treatment conferred no additional benefit.

FAACT demonstrated improved quality of life among megestrol acetate–treated and combination-treated patients. Uniscale scores were similar for both groups. Toxicity among groups was comparable, with the exception of a greater incidence of impotence among men who received megestrol acetate.

• The study lacked a constitutive definition of anorexia.
• Eligibility criteria used self-reported weight loss and physician estimates of caloric intake.
• Outcome measures used weight measurement in the oncologist’s office; accuracy and precision of the scale used to assess weight were not explicated.
• Validity and reliability of instruments was not included.
• Recruitment sites were listed, but these settings were not described.
• Cost implications were not discussed.