None listed
Conditions
Brief summary
This study aims to evaluate the efficacy of nutrition therapy with additional high intensity interval training in improving cancer-related fatigue and quality of life in men with prostate cancer on androgen deprivation therapy. Who is it for? Men aged 18 years or over who have prostate cancer and are currently being treated with androgen deprivation therapy (ADT), for longer than 3 months. Study details Research has found that men with prostate cancer treated with ADT have a high prevalence of cancer-related fatigue, which affects quality of life during and after treatment. Whilst the benefits of both dietary modification and exercise prescription have been well described in prostate cancer prevention and progression, little is known about the influence of nutrition therapy and high intensity exercise on cancer-related fatigue in men with prostate cancer during or after ADT treatment. This study aims to evaluate the efficacy of nutrition therapy and high intensity exercise in prostate cancer-related fatigue. All participants in this study are randomly allocated (by chance) to one of the two groups. Participants in one group will be invited to attend fortnightly 45 min long dietetic consults with an Accredited Practicing Dietitian for 20 weeks and to undertake high intensity interval training sessions, 3 times per week, in weeks 12-20. Participants in the second group will receive usual care monitoring followed by moderate or high intensity interval training, 3 times per week, for eight weeks after usual care has finished. The usual care group will continue to be treated with ADT, or adjunctive ADT with chemotherapy/radiotherapy for the study duration. Throughout the study, participants will be asked to answer questionnaires on prostate cancer-related fatigue and quality of life as well as have blood samples taken and perform some physical function tests. It is hoped that this study will help assist in alleviating cancer-related fatigue, and improving quality of life for men with prostate cancer treated with ADT.
Interventions
This research will evaluate the efficacy of a nutrition therapy with additional exercise in managing prostate cancer-related fatigue, in men treated with androgen deprivation therapy, among residents in Queensland.
Study Design
The study is designed as a two-arm 20-week randomised controlled trial.
Participants
All men treated with androgen deprivation therapy (ADT), or adjunctive ADT with chemotherapy and/or radiotherapy for longer than three months will be involved in the study. Participan
This research will evaluate the efficacy of a nutrition therapy with additional exercise in managing prostate cancer-related fatigue, in men treated with androgen deprivation therapy, among residents in Queensland. Study Design The study is designed as a two-arm 20-week randomised controlled trial. Participants All men treated with androgen deprivation therapy (ADT), or adjunctive ADT with chemotherapy and/or radiotherapy for longer than three months will be involved in the study. Participants will be recruited from the Mater Hospital Brisbane Queensland, The University of Queensland, Cancer Council Queensland, and the Prostate Cancer Foundation of Australia support groups located in Brisbane Queensland. Sample size calculations showed that a total of 116 participants are needed to detect statistically significant differences in prostate cancer-related fatigue. Intervention group Participants will be invited to attend fortnightly dietetic consults with an Accredited Practicing Dietitian for 20 weeks. The diet composition is developed in accordance to evidence based literature and will encompass anti-inflammatory foods targeted to reduce metabolic parameters, and improve cancer-related fatigue. Participants will be provided individualised diet plan to follow. Dietary adherence will be monitored each fortnight through dietetic consults; of approximately 45 minutes. From weeks 12-20 participants will additionally undertake exercise sessions, which may be conducted in groups of up to four participants, three times per week. Exercise will involve 4x4 minutes at high intensity of 85-90% of heart rate peak, interspersed by 3-minute periods of recovery at a lower intensity on a bicycle ergometer at 50-70% heart rate peak. All high intensity exercise sessions will include a 10-minute warm-up and 5 min cool down. With warm-ups and cool-downs each exercise session will last approximately 40 minutes in total; conducted by an Accredited Exercise Physiologist.
Sponsors
Brenton Baguley
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
If you have prostate cancer and are currently being treated with androgen deprivation therapy, for longer than 3 months.
Exclusion criteria
1. Currently smoke 2. Body mass index above 18.5 kg/m2 (underweight) or equal/below 35.0 kg/m2 (obese class II) 3. Current infection 4. Bone metastases; excluded for exercise safety 5. Currently taking supplements other than singe multivitamin; unless for medical purposes. 7. Currently undertaking high intensity exercise 8. Have any medical conditions (musculoskeletal, cardiopulmonary or metabolic) that would prevent their safe participation in the exercises program
Outcome results
None listed