Capozzi, L.C., McNeely, M.L., Lau, H.Y., Reimer, R.A., Giese-Davis, J., Fung, T.S., & Culos-Reed, S.N. (2016). Patient-reported outcomes, body composition, and nutrition status in patients with head and neck cancer: Results from an exploratory randomized controlled exercise trial. Cancer, 122, 1185–1200.

To detect the optimal timing for the initiation of an exercise training intervention

This was a 12-week lifestyle intervention consisting of five components: physician referral and clinic support, health education, behavior change support, social support through group-based settings, and an individualized exercise program based on patient need. Patients were asked to attend exercise sessions twice a week with additional at-home implementation of the exercise regimen twice more per week. The individualized exercise programs consisted of progressive resistance-training programs with a short, moderate intensity warm-up followed by two sets of 8 repetitions for 10 exercises. Progression of the regimen occurred at weeks 4, 6, and 9, as appropriate. In addition to attending the exercise sessions, participants were required to attend six education sessions after their exercise sessions.

• N = 60   
• AGE = 56.1 years (SD = 9.2 years)
• MALES: 81.7%, FEMALES: 20.3%
• CURRENT TREATMENT: Chemotherapy, radiation, combination radiation and chemotherapy
• KEY DISEASE CHARACTERISTICS: Head and neck cancer

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: University of Calgary

PHASE OF CARE: Multiple phases of care

The study design is a randomized, controlled exercise trial in which patients were randomly assigned to either the immediate lifestyle intervention (ILI) group or the delayed lifestyle intervention (DLI) group.

• Godin Leisure-Time Exercise Questionnaire
• Functional Assessment of Cancer Therapy (FACT)
• FACT-Anemia (FACT-An)
• FACT Head/Neck Symptom Index-22 (FHNSI-22)
• FACT-An Trial Outcome Index
• Center for Epidemiological Study Depression Scale (CESD)
• Patient-Generated Subjective Global Assessment (PG-SGA)
• Intervention survey
• Body composition, fitness, functional, flexibility tools

No significant differences were reported for lean body mass or percentage body fat during the 24 weeks. A main effect of time for lean body mass, body mass index, and percentage body fat was detected (lean body mass: F[2,74.5] = 54.141, p < 0.001; BMI: F[2,74.5] = 67.955, p < 0.001; percent body fat: F[2,74.5] = 29.679, p < 0.001). No between group statistical difference was detected for fitness outcomes, the six-minute walk test (6MWT), or the sit-to-stand test (SST), which may be because of the small sample size. No statistical differences were observed between the two groups’ quality of life during the 24-week period. A significant effect was observed on depression, but no associated difference was observed between study groups.

The intervention did not demonstrate an effect on patient outcomes.

• Small sample (< 100)
• Risk of bias (no blinding)
• Findings not generalizable

This study did not show efficacy of an intervention involving exercise and supportive interventions. The findings are limited by study design aspects and sample size.