Evaluation of diet and exercise in prostate cancer-related fatigue

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000512527
• Date of registration: 22/05/2015
• Prospective Registration: Yes
• Primary sponsor: Brenton Baguley
• Public title: Evaluation of diet and exercise in prostate cancer-related fatigue
• Scientific title: Can nutrition therapy with additional high intensity interval training improve cancer-related fatigue and quality of life in men with prostate cancer on androgen deprivation therapy?
• Date of first enrolment: 15/10/2015
• Target sample size: 116
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12615000512527.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Mr Brenton Baguley

• Name: Mr Brenton Baguley

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: No limit
Gender: Males

Health Condition(s) or Problem(s) studied

Cancer - Prostate

Prostate Cancer treated with Androgen Deprivation therapy ;Cancer-related fatigue;
Prostate Cancer treated with Androgen Deprivation therapy

Cancer-related fatigue

Diet and Nutrition - Other diet and nutrition disorders

Physical Medicine / Rehabilitation - Physiotherapy

Intervention(s)

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 exer

Primary Outcome(s)

Prostate cancer-related fatigue questionnaires measured by; functional assessment of cancer therapy: fatigue [At baseline and weeks 8, 12, 20 (and weeks 24 and 28 for the usual care group). ]

Prostate cancer-related quality of life questionnaires measured by; EORTC QLQ – PR25 prostate cancer-specific health-related quality of life self-assessment questionnaire.[At baseline and weeks 8, 12, 20 (and weeks 24 and 28 for the usual care group).]

Prostate cancer-related quality of life questionnaires measured by; The European organization for Research and Treatment of Cancer Quality of Life Questionnaire; EORTC QLQ – C30,[At baseline and weeks 8, 12, 20 (and weeks 24 and 28 for the usual care group).]

Secondary Outcome(s)

Blood Analysis; blood will be sampled to enable assessment of metabolic biomarkers, and prostate cancer biomarkers that have been linked to prostate cancer growth.[At baseline and weeks 8, 12, 20 (and weeks 24 and 28 for the usual care group).]

Body composition; muscle and fat mass of the whole body will be measured by dual energy x-ray absorptiometry (DXA), a routine technique for the measure of body composition.[At baseline, weeks 8, 12, 20 (and weeks 24 and 28 for the control group)]

Diet history; detailed information about each meal, including the timing, foods consumed, and the amount and frequency of consumption. [At baseline and weeks 8, 12, 20 (and weeks 24 and 28 for the usual care group).]

Additional measures; supplementary questions of Depression Anxiety Stress Scales, Pittsburg Sleep Quality Index, Physical Activity Enjoyment Scales, Godin leisure-time exercise, and Dietetic Enjoyment scales.[At baseline and weeks 8, 12, 20 (and weeks 24 and 28 for the usual care group).]

Cardiorespiratory fitness; involves cycling on an exercise bike for 10-15 minutes whilst breathing normal room air whilst wearing an apparatus that measures your oxygen consumption. [At baseline and weeks 8, 12, 20 (and weeks 24 and 28 for the usual care group).]

Physical function; a battery of tests include isometric grip strength (involves gripping a hand-held device and squeezing as hard as possible for a few seconds), sit to stand (involves standing up from a chair 5 times as fast as safely possible), 6-m usual walk and 6-m fast walk (involves walking a marked 10-m distance at their usual speed and then as quickly as safely possible), the 400-m walk test (involves walking 400 m as fast as safely possible, which consists of 10 laps out and back over a 20-m course), and one-repetition maximum tests (involves pushing as much weight as safely possible with your arms or legs once).[At baseline, weeks 8, 12, 20 (and weeks 24 and 28 for the control group)]

Secondary ID(s)

Nil Known

Source(s) of Monetary Support

School of Human Movement and Nutrition Sciences, The University of Queensland

Secondary Sponsor(s)

Dr Olivia Wright

Dr Tina Skinner

Dr Michael Leveritt

Ms Kirsten Adlard

Ethics review

Status: Approved
Approval date:
Contact:

Medical Research Ethics Committee