Condition category
Cancer
Date applied
24/08/2005
Date assigned
25/10/2005
Last edited
13/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.shu.ac.uk

Funders

Funder type

Research organisation

Funder name

American Institute for Cancer Research (USA) (ref: 05A008)

Alternative name(s)

American Institute for Cancer Research, Inc., AICR

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United States of America

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

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes