Condition category
Cancer
Date applied
09/09/2009
Date assigned
08/10/2009
Last edited
28/06/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Marie Cantwell

ORCID ID

Contact details

Centre for Public Health
Queen's University Belfast
Mullhouse Building
Royal Victoria Hospital
Grosvenor Rd
Belfast
BT12 6BJ
United Kingdom
+44 28 90634800
m.cantwell@qub.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomised controlled trial to evaluate the efficacy of a 6 month dietary and physical activity intervention for prostate cancer patients receiving androgen deprivation therapy

Acronym

Prostate Nutrition Study

Study hypothesis

Hypothesis is that the diet and physical activity intervention will;
1. Prevent or reduce weight gain, and prevent or reduce the increase in body fat mass typically found in patients treated with androgen deprivation therapy compared to the controls
2. Improve fatigue scores for those in the intervention group compared to those in the control group
3. Improve quality of life scores for those in the intervention group compared to those in the control group

As of 01/03/2011 the anticipated end date for this trial has been updated from 30/09/2010 to 01/07/2011

Ethics approval

Office for Research Ethics Committees Northern Ireland, approved on 21/05/2009 (ref: 09/NIR03/41)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Prostate cancer patients receiving androgen deprivation therapy

Intervention

The intervention will consist of two components, a dietary intervention and a moderate physical activity intervention.

Dietary modification: The intervention group will meet individually with a nutritionist to receive dietary advice based on their usual diet measured at baseline in order to encourage them to adopt a diet to meet current dietary guidelines listed below:
a. Eat 5 or more servings of vegetables and fruits per day
b. Reduce total fat intake 30%-35% of total energy, with <10% saturated fat intake
c. Limit polyunsaturated fat intake to 10% of daily total energy intake
d. Limit consumption of processed meats
e. Eat fibre-rich foods. Aim to consume 25 to 35g of fibre daily.
f. Limit alcohol intake 28 units/ week
g. Limit intake of foods high in salt and/or sugar

Moderate physical activity: Brisk walking at least 30 min per day, in addition to usual activities on 5 or more days of the week.

The control group will receive ‘’usual care’’ only.

Details of Joint Sponsor:
Queens University Belfast
Research and Regional Services
Room 103, Lanyon North
Belfast, BT7 1NN
United Kingdom

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Body Composition: Anthropometric measurement at baseline, mid-time (3 months) and end (6 months)
2. Fatigue: Self administrated Fatigue Severity Scale (FSS) questionnaire at baseline, mid-time (3 months) and end (6 months)
3. Quality of life: Self administrated Functional Assessment of Cancer Therapy-General (FACT-G) and Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire at baseline, mid-time (3 months) and end (6 months)

Secondary outcome measures

The feasibility of dietary and physical activity intervention will be assessed by drop-out and effectiveness of intervention at the end of intervention.

Overall trial start date

06/08/2009

Overall trial end date

01/07/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically proven adenocarcinoma of prostate
2. Commencing Lutenising Hormone Releasing Hormone Agonist (LHRHa) therapy for at least 6 months OR already being treated with LHRHa and planned to continue for at least a further 6 months
3. No age limit

Participant type

Patient

Age group

Other

Gender

Male

Target number of participants

94

Participant exclusion criteria

1. Co-morbid condition that limits physical activity such as severe cardiac disease, recent myocardial infarction, severe asthma or breathlessness, uncontrolled hypertension (blood pressure >160/95 mm/Hg) or severe pain
2. Medical conditions that requires a reduced fruit and vegetable diet (e.g. kidney failure)
3. Life expectancy of less than 2 years

Recruitment start date

06/08/2009

Recruitment end date

01/07/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Public Health
Belfast
BT12 6BJ
United Kingdom

Sponsor information

Organisation

Belfast Health and Social Care Trust (UK)

Sponsor details

Knockbracken Healthcare Park
Saintfield Rd
Belfast
BT8 8BH
United Kingdom

Sponsor type

Government

Website

http://www.belfasttrust.hscni.net/

Funders

Funder type

University/education

Funder name

Queen's University Belfast (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20704726

Publication citations

  1. Protocol

    Haseen F, Murray LJ, O'Neill RF, O'Sullivan JM, Cantwell MM, A randomised controlled trial to evaluate the efficacy of a 6 month dietary and physical activity intervention for prostate cancer patients receiving androgen deprivation therapy., Trials, 2010, 11, 86, doi: 10.1186/1745-6215-11-86.

Additional files

Editorial Notes