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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
ISRCTN ISRCTN08045231
DOI 10.1186/ISRCTN08045231
ClinicalTrials.gov identifier NCT00689975
EudraCT number
Public 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
Scientific title
Acronym N/A
Serial number at source 05A008
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
Lay summary http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-the-effect-of-exercise-and-dietary-changes-for-women-recovering-from-breast-cancer-treatment
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Breast cancer
Participants - 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
Participants - 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)
Anticipated start date 01/10/2005
Anticipated end date 30/09/2007
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 100
Interventions Exercise and dietary intervention versus no intervention.
Primary outcome measure(s) Body weight; body composition.
Secondary outcome measure(s) Psychological health status; biomarkers associated with disease recurrence (including stress hormones, immune function, inflammatory mediators); quality of life; cardiovascular fitness.
Sources of funding American Institute for Cancer Research (USA) (ref: 05A008)
Trial website
Publications 1. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16469108
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23184120
Contact name Dr  John  Saxton
  Address Centre for Sport and Exercise Science
Sheffield Hallam University
Collegiate Crescent Campus
  City/town Sheffield
  Zip/Postcode S10 2BP
  Country United Kingdom
  Tel +44 (0)114 225 4414
  Fax +44 (0)114 225 4341
  Email j.m.saxton@shu.ac.uk
Sponsor Sheffield Hallam University (UK)
  Address City Campus
Howard Street
  City/town Sheffield
  Zip/Postcode S1 1WB
  Country United Kingdom
  Tel +44 (0)114 225 5555
  Fax +44 (0)114 225 4341
  Email liaison@shu.ac.uk
  Sponsor website: http://www.shu.ac.uk
Date applied 24/08/2005
Last edited 29/05/2013
Date ISRCTN assigned 25/10/2005
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