Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000512527
Ethics application status
Approved
Date submitted
1/04/2015
Date registered
22/05/2015
Date last updated
29/10/2015
Type of registration
Prospectively registered

Titles & IDs
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?
Secondary ID [1] 286464 0
Nil Known
Universal Trial Number (UTN)
U1111-1168-9443
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer treated with Androgen Deprivation therapy
 294652 0
Cancer-related fatigue 294758 0
Condition category
Condition code
Diet and Nutrition 294948 294948 0 0
Other diet and nutrition disorders
Physical Medicine / Rehabilitation 294949 294949 0 0
Physiotherapy
Cancer 294950 294950 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 291548 0
Lifestyle
Intervention code [2] 291549 0
Prevention
Intervention code [3] 291621 0
Treatment: Other
Comparator / control treatment
Control Group
The control group will be monitored for a period of 20 weeks usual care receiving ADT, or adjunctive ADT with chemotherapy and/or radiotherapy. The usual care group will then be randomly allocated through a computerised program, to undertake eight weeks of moderate intensity exercise or high intensity interval training after the 20-week usual care monitoring period has finished. Moderate intensity exercise will consist of 50 minutes of cycling at a 50-70% heart rate peak on a bicycle ergometer. The high intensity exercise will involve 4x4 minutes at high intensity at 85-90% of heart rate peak, interspersed by 3-minute periods of recovery at a lower intensity of 50-70% heart rate peak on a bicycle ergometer. All exercise sessions will include a 10-minute warm-up and 5 min cool down.
Control group
Active

Outcomes
Primary outcome [1] 294704 0
Prostate cancer-related fatigue questionnaires measured by; functional assessment of cancer therapy: fatigue
Timepoint [1] 294704 0
At baseline and weeks 8, 12, 20 (and weeks 24 and 28 for the usual care group).
Primary outcome [2] 294801 0
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,
Timepoint [2] 294801 0
At baseline and weeks 8, 12, 20 (and weeks 24 and 28 for the usual care group).
Primary outcome [3] 294802 0
Prostate cancer-related quality of life questionnaires measured by; EORTC QLQ – PR25 prostate cancer-specific health-related quality of life self-assessment questionnaire.
Timepoint [3] 294802 0
At baseline and weeks 8, 12, 20 (and weeks 24 and 28 for the usual care group).
Secondary outcome [1] 313895 0
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.
Timepoint [1] 313895 0
At baseline, weeks 8, 12, 20 (and weeks 24 and 28 for the control group)
Secondary outcome [2] 314078 0
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).
Timepoint [2] 314078 0
At baseline, weeks 8, 12, 20 (and weeks 24 and 28 for the control group)
Secondary outcome [3] 314079 0
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.
Timepoint [3] 314079 0
At baseline and weeks 8, 12, 20 (and weeks 24 and 28 for the usual care group).
Secondary outcome [4] 314080 0
Blood Analysis; blood will be sampled to enable assessment of metabolic biomarkers, and prostate cancer biomarkers that have been linked to prostate cancer growth.
Timepoint [4] 314080 0
At baseline and weeks 8, 12, 20 (and weeks 24 and 28 for the usual care group).
Secondary outcome [5] 314081 0
Diet history; detailed information about each meal, including the timing, foods consumed, and the amount and frequency of consumption.
Timepoint [5] 314081 0
At baseline and weeks 8, 12, 20 (and weeks 24 and 28 for the usual care group).
Secondary outcome [6] 314082 0
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.
Timepoint [6] 314082 0
At baseline and weeks 8, 12, 20 (and weeks 24 and 28 for the usual care group).

Eligibility
Key inclusion criteria
If you have prostate cancer and are currently being treated with androgen deprivation therapy, for longer than 3 months.

Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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. Participants from the Mater hospital will be identified by the site specific Prostate Cancer Specialist Nurse, and provided with an information sheet, consent form for the study, and contact details for the study. Participants will also be recruited by way of media releases, presentations and advertisements in newsletters, newspapers, and noticeboards at The University of Queensland, Cancer Council Queensland, and the Prostate Cancer Foundation of Australia support groups. All interested participants will be encouraged to email or phone primary investigator, or will be contacted by primary investigator for eligibility. All individuals interested in participating in the study, will be provided with a study information sheet for the study, then participant eligibility and trial scheduling times will be discussed. Information sheets/consent forms will be provided once eligibility is ensured. Once the participant has read, understood and signed the consent form, the first trial and baseline measurements dates will be agreed upon. Randomisation will take place after completion of baseline testing, using a computerised random sequencing generator, by a person external from the primary and co-investigators at the University of Queensland.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Combined diet and exercise interventions, with cancer-related fatigue as the primary outcome are relatively limited. One diet and exercise intervention in men treated with ADT showed cancer-related fatigue (FACT-F) scores increase of 3.7 – 14.2 (CI, 95%; adjusted mean 8.9 points). Assuming the group was normally distributed with a SD of 8.9, and the true difference in the experimental and control arms were 5.2, we would need 47 experimental and control subjects to be able to reject the null hypothesis, with a probability (power) of 0.8. The type 1 error probability associated with this test of this null hypothesis is 0.05. With a 20% attrition rate, to maintain statistical significance in sample size calculation, we would need 58 experimental and control group subjects to be able to reject the null hypothesis.

Data will be analysed using the SPSS statistical software package (version 20.0, SPSS, Inc., Chicago, IL). Analyses will include standard descriptive statistics, t tests, correlation, regression and two-way repeated measures ANOVA or the comparable non-parametric test as necessary to examine differences between and within groups, from baseline, week 8, 12, 20, 24 and 28.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/06/2015
Actual
15/10/2015
Date of last participant enrolment
Anticipated
9/11/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
116
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 3644 0
Mater Private Hospital - South Brisbane
Recruitment postcode(s) [1] 9483 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 291032 0
University
Name [1] 291032 0
School of Human Movement and Nutrition Sciences, The University of Queensland
Country [1] 291032 0
Australia
Primary sponsor type
Individual
Name
Brenton Baguley
Address
School of Human Movement and Nutrition Sciences (#26B) Cnr Blair Drive & Union Road The University of Queensland, St Lucia Campus Brisbane Qld 4072
Country
Australia
Secondary sponsor category [1] 289714 0
Individual
Name [1] 289714 0
Dr Olivia Wright
Address [1] 289714 0
School of Human Movement and Nutrition Sciences (#26B) Cnr Blair Drive & Union Road, The University of Queensland, St Lucia Campus Brisbane Qld 4072
Country [1] 289714 0
Australia
Secondary sponsor category [2] 289715 0
Individual
Name [2] 289715 0
Dr Tina Skinner
Address [2] 289715 0
School of Human Movement and Nutrition Sciences (#26B) Cnr Blair Drive & Union Road, The University of Queensland, St Lucia Campus Brisbane Qld 4072
Country [2] 289715 0
Australia
Secondary sponsor category [3] 289716 0
Individual
Name [3] 289716 0
Dr Michael Leveritt
Address [3] 289716 0
School of Human Movement and Nutrition Sciences (#26B) Cnr Blair Drive & Union Road, The University of Queensland, St Lucia Campus Brisbane Qld 4072
Country [3] 289716 0
Australia
Secondary sponsor category [4] 289717 0
Individual
Name [4] 289717 0
Ms Kirsten Adlard
Address [4] 289717 0
School of Human Movement and Nutrition Sciences (#26B) Cnr Blair Drive & Union Road, The University of Queensland, St Lucia Campus Brisbane Qld 4072
Country [4] 289717 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292616 0
Medical Research Ethics Committee
Ethics committee address [1] 292616 0
Ethics committee country [1] 292616 0
Australia
Date submitted for ethics approval [1] 292616 0
07/04/2015
Approval date [1] 292616 0
31/07/2015
Ethics approval number [1] 292616 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56238 0
Mr Brenton Baguley
Address 56238 0
School of Human Movement and Nutrition Sciences (#26B) Cnr Blair Drive & Union Road, The University of Queensland, St Lucia Campus Brisbane Qld 4072
Country 56238 0
Australia
Phone 56238 0
+61 7 3365 6313
Fax 56238 0
Email 56238 0
[email protected]
Contact person for public queries
Name 56239 0
Brenton Baguley
Address 56239 0
School of Human Movement and Nutrition Sciences (#26B) Cnr Blair Drive & Union Road, The University of Queensland, St Lucia Campus Brisbane Qld 4072
Country 56239 0
Australia
Phone 56239 0
+61 7 3365 6313
Fax 56239 0
Email 56239 0
[email protected]
Contact person for scientific queries
Name 56240 0
Brenton Baguley
Address 56240 0
School of Human Movement and Nutrition Sciences (#26B) Cnr Blair Drive & Union Road, The University of Queensland, St Lucia Campus Brisbane Qld 4072
Country 56240 0
Australia
Phone 56240 0
+61 7 3365 6313
Fax 56240 0
Email 56240 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseMediterranean-style dietary pattern improves cancer-related fatigue and quality of life in men with prostate cancer treated with androgen deprivation therapy: A pilot randomised control trial.2021https://dx.doi.org/10.1016/j.clnu.2020.05.016
EmbaseMediterranean Style Dietary Pattern with High Intensity Interval Training in Men with Prostate Cancer Treated with Androgen Deprivation Therapy: A Pilot Randomised Control Trial.2022https://dx.doi.org/10.3390/ijerph19095709
N.B. These documents automatically identified may not have been verified by the study sponsor.