Contact information
Type
Scientific
Primary contact
Dr John Saxton
ORCID ID
Contact details
Centre for Sport and Exercise Science
Sheffield Hallam University
Collegiate Crescent Campus
Sheffield
S10 2BP
United Kingdom
+44 (0)114 225 4414
j.m.saxton@shu.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00689975
Protocol/serial number
05A008
Study information
Scientific title
The effect of a lifestyle intervention on body weight, psychological health status and risk factors associated with disease recurrence in women recovering from breast cancer treatment
Acronym
Study hypothesis
1. A dietary and exercise intervention will evoke a reduction in body weight in overweight or obese women who have undergone breast cancer treatment
2. A dietary and exercise intervention will evoke positive changes in indices of psychological health status and biomarkers associated with disease recurrence in overweight or obese women who have undergone breast cancer treatment
Ethics approval
Not provided at time of registration
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
Breast cancer
Intervention
Exercise and dietary intervention versus no intervention.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Body weight; body composition.
Secondary outcome measures
Psychological health status; biomarkers associated with disease recurrence (including stress hormones, immune function, inflammatory mediators); quality of life; cardiovascular fitness.
Overall trial start date
01/10/2005
Overall trial end date
30/09/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women who have undergone appropriate treatment for operable breast cancer within the past 3-18 months and are no longer undergoing chemotherapy or radiation therapy, will be recruited from the Cancer Research Centre, Weston Park Hospital, Sheffield University Hospitals NHS Trust
2. Postmenopausal women (confirmed by plasma estradiol and gonadotrophin measures in all women aged <55) with a body mass index (BMI) >25 and classified as disease stage I-III
3. Patients must have completed some form of breast cancer treatment at least three months, and not more than 18 months ago
4. Patients on Tamoxifen and other endocrine treatments but not hormone replacement therapy (HRT) will be included
5. Patients must be willing and able to attend supervised exercise sessions at least 3 times per week for a period of 24 weeks, with the intention of achieving an 80% minimum compliance target for attendance
6. Patients must be an exercise pre-contemplator, contemplator or preparer as defined by the Transtheoretical Model
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
100
Participant exclusion criteria
1. Metastatic breast cancer patients and patients with inoperable or active loco-regional disease
2. Patients following alternative/complementary diets or taking high dose antioxidant supplements
3. Patients with a physical/psychiatric impairment that would seriously impair their physical mobility
4. Patients who are currently suffering from severe nausea, anorexia or other diseases affecting health (e.g. arthritis and multiple sclerosis)
5. HRT is not commonly prescribed in women who are recovering from breast cancer treatment, but use of HRT or oral contraceptives within the past four months is an exclusion criteria
6. Patients who are currently engaged in exercise (two or more times per week for at least 30 min per session during the previous 3 months)
Recruitment start date
01/10/2005
Recruitment end date
30/09/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Centre for Sport and Exercise Science
Sheffield
S10 2BP
United Kingdom
Sponsor information
Organisation
Sheffield Hallam University (UK)
Sponsor details
City Campus
Howard Street
Sheffield
S1 1WB
United Kingdom
+44 (0)114 225 5555
liaison@shu.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
American Institute for Cancer Research (USA) (ref: 05A008)
Alternative name(s)
AICR
Funding Body Type
unknown
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list
2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16469108
2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23184120
2014 results in http://www.ncbi.nlm.nih.gov/pubmed/24731917
Publication citations
-
Protocol
Saxton JM, Daley A, Woodroofe N, Coleman R, Powers H, Mutrie N, Siddall V, Crank H, Study protocol to investigate the effect of a lifestyle intervention on body weight, psychological health status and risk factors associated with disease recurrence in women recovering from breast cancer treatment [ISRCTN08045231]., BMC Cancer, 2006, 6, 35, doi: 10.1186/1471-2407-6-35.
-
Results
Scott E, Daley AJ, Doll H, Woodroofe N, Coleman RE, Mutrie N, Crank H, Powers HJ, Saxton JM, Effects of an exercise and hypocaloric healthy eating program on biomarkers associated with long-term prognosis after early-stage breast cancer: a randomized controlled trial., Cancer Causes Control, 2013, 24, 1, 181-191, doi: 10.1007/s10552-012-0104-x.
-
Results
Saxton JM, Scott EJ, Daley AJ, Woodroofe M, Mutrie N, Crank H, Powers HJ, Coleman RE, Effects of an exercise and hypocaloric healthy eating intervention on indices of psychological health status, hypothalamic-pituitary-adrenal axis regulation and immune function after early-stage breast cancer: a randomised controlled trial, Breast Cancer Res, 2014, 16, 2, doi: 10.1186/bcr3643.