Rogers, L.Q., Anton, P.M., Fogleman, A., Hopkins-Price, P., Verhulst, S., Rao, K., . . . Robbins, K.T. (2013). Pilot, randomized trial of resistance exercise during radiation therapy for head and neck cancer. Head & Neck, 35, 1178–1188. 

DOI Link

Study Purpose

To determine the feasibility of conducting a randomized, controlled trial of exercise in patients with head and neck cancer receiving radiation therapy

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to the intervention group or a control group. Control patients received only nutritional counseling from a registered dietician. Patients in the intervention group received nutritional counseling plus the exercise intervention. Exercise included twice-weekly, supervised exercise sessions for six weeks followed by six weeks of twice-weekly home-based sessions supported by weekly telephone counseling, written materials, and a DVD.

Sample Characteristics

  • N = 13 (completed 12 weeks); 15 (completed six weeks)  
  • MEAN AGE = 60.5 years (SD = 43–88 years)
  • MALES: 80%, FEMALES: 20%
  • KEY DISEASE CHARACTERISTICS: All patients had head and neck cancer. About one half had had neck dissection, and one half also received concurrent chemotherapy.

Setting

  • SITE: Single-site  
  • SETTING TYPE: Outpatient  
  • LOCATION: Illinois

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Elder care

Study Design

Pilot randomized, controlled trial

Measurement Instruments/Methods

  • Lean body mass measured by biometric impedance
  • Functional Assessment of Cancer Therapy–Fatigue (FACT-F)
  • Functional Assessment of Cancer Therapy–Head and Neck (FACT-H&N)
  • Physical performance tests

Results

Over the first six weeks, fatigue increased in both groups with no significant difference between groups. Between weeks 6 and 12, fatigue declined in both groups but showed a greater decline in the intervention group. Exercise adherence was 87% in the first six weeks and 57% weeks 7–12.

Conclusions

Less than one half of patients offered the study consented to participate, suggesting low interest and limited feasibility. The final sample size was very small, so no firm conclusions about effects can be drawn.

Limitations

  • Small sample (< 30)
  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)

 

Nursing Implications

This study provides minimal support for the feasibility and efficacy of implementing an exercise intervention among patients with head and neck cancer undergoing radiation therapy. These findings are not in concert with findings from other similar studies.