Optimising physical fitness in patients receiving chemo-radiotherapy for head and neck cancer

  • Topic:
  • Institution: University Medical Centre Utrecht (UMCU)
  • Country: Netherlands
  • Status: Ongoing

Scientific abstract

(View plain language abstract)

Background

Head and neck cancer (HNC) and its treatment with concurrent chemo-radiotherapy (CRT) have a profound negative impact on physical functioning, body composition, fatigue and quality of life (QoL). Studies in other cancer populations have shown the benefits of physical exercise on these side effects of cancer treatment. HNC patients may also benefit from exercising during treatment, but studies in this population are scarce. Due to the high symptom load associated with CRT, engaging in exercise programmes is challenging for these patients. Therefore, a feasibility study is needed to assess uptake, adherence, tolerability and participant satisfaction of such a programme during CRT.

Hypothesis and objectives

We hypothesise that, ultimately, an exercise intervention will have beneficial effects on fitness, body composition, fatigue, treatment tolerability and QoL. Therefore, we here propose a feasibility study in order to design an optimal, large-scale RCT for testing our hypothesis.

Primary objective (feasibility)

  • To determine adherence to and compliance with the exercise intervention.
  • To explore patients' satisfaction with the exercise intervention.
  • To determine recruitment and retention rates.

Secondary objectives

  • To obtain preliminary data for power calculations for a future RCT.
  • To compare changes in physical performance and muscle strength, body composition, fatigue, QoL, and CRT tolerability in our sample to those reported in the literature for this population.

Settings and methods

Design

A 2-centre pre-post study using a mixed methods design. Quantitative measures will be obtained on intervention feasibility, physical function and self-reported health outcomes, and qualitative methods (interviews) will be used to gain insight into the participants' perspective on feasibility, satisfaction and intervention improvements.

Population

Thirty-seven HNC patients scheduled for CRT.

Intervention

The 10-week intervention (duration of CRT+3 weeks) consists of 30 minutes of moderate-intensity aerobic activity (six days/week), and resistance exercises for three days/week. At least one exercise session/week is supervised, further home-based. The intervention is adapted to individual capacity, and behavioural support is offered during the supervised exercise sessions. Nutritional support will be provided as part of usual care.

Outcomes

Feasibility outcomes are adherence to and compliance with the exercise programme, recruitment and retention in the study. The experiences of study participants with the intervention will be explored in semi-structured interviews. Preliminary outcome data on physical fitness, body composition, fatigue, QoL and CRT tolerability will be obtained at baseline and 12-week post-baseline.

Statistical analysis

Quantitative results will be presented descriptively with percentages, means and standard deviations. Changes in physical fitness, body composition, fatigue and QoL data are estimated as medians with 95% confidence intervals obtained by bootstrapping. Semi-structured interviews will be analysed using thematic descriptive analyses and the software package NVivo.

Impact

The outcomes of this feasibility study will have an impact on the design of an RCT, comparing the exercise intervention to usual care during CRT as developed, tested and optimized here. If demonstrated to be effective in a future RCT, the intervention can be implemented in usual care and should improve health outcomes for this population.

Plain language abstract

Background

Head and neck cancer (HNC) is one of the most frequent tumours in the world. Five years after treatment, 58% of HNC patients are still alive in the Netherlands. Advanced tumours are treated by concurrent chemo-radiotherapy (CRT), which has a large impact on physical functioning, muscle strength and quality of life (QoL) and patients are often fatigued. Hence, side effects of CRT are heavy for HNC patients and interventions that potentially decrease side effects and increase QoL are needed. Studies in other cancer populations have shown the benefit from exercising during chemotherapy and radiotherapy, but exercise studies for HNC patients are scarce and knowledge about an exercise intervention optimally tailored to the needs of HNC patients is lacking. Therefore, we propose to test the feasibility of an exercise intervention, which is developed based on literature, clinical experience and patients' interviews, during CRT for HNC patients by assessing uptake, adherence, tolerability and participant satisfaction.

Aims and objectives

We aim to perform a feasibility study investigating uptake, adherence, tolerability and participant satisfaction of a ten-week exercise training intervention in HNC patients. We will also assess physical performance and muscle strength, body composition, fatigue, QoL and CRT tolerability to relate these outcomes to those reported in the literature for HNC patients.

How it will be done

Thirty-seven patients scheduled for CRT in two hospitals in the Netherlands, who are specialized in HNC treatment, will be included. The exercise intervention will take place during CRT (seven weeks) and will continue till three weeks after CRT completion. Patients will perform the exercise intervention on six days each week: three combined endurance and resistance exercise sessions and three endurance exercise sessions. At least one of the combined endurance and resistance exercise sessions will be supervised by a physiotherapist in the treating hospital. The physiotherapist will give instructions on proper exercise performance, adjust the exercise intensity and discuss the home-based exercises. Endurance exercise (eg brisk walking, cycling) will be performed with moderate intensity (Borg score 12-15 and 60% of estimated maximum heart rate). Resistance exercise sessions will consist of six strength exercises targeting all large muscle groups done with moderate intensity ((50-70% 1RM).

The primary outcome is the feasibility of the exercise intervention:

  • Adherence/performance at/of the exercise sessions.
  • Compliance with the exercise protocol.
  • Number of patients who want to participate in this study.
  • Number of patients who complete the study.
  • Participant satisfaction will be explored by interviews with the patients.
  • Number of supervised exercise sessions attended.

Secondary outcomes are physical performance and muscle strength, body composition, QoL, fatigue, physical activity and CRT tolerability. Outcome measures will be assessed before and after the exercise intervention.

Potential impact

The outcomes of this feasibility study will have an impact on the design of a future randomized controlled trial (RCT), comparing the exercise intervention to usual care during CRT as developed, tested and optimized here. If demonstrated to be effective in a future RCT, the intervention can be implemented in the usual care and should improve health outcomes for this population.