NCT00689975

Brief Summary

RATIONALE: Studying diet and exercise interventions in overweight and obese patients with breast cancer may help doctors learn more about how to help patients lose weight and change their body composition. PURPOSE: This randomized clinical trial is studying diet and exercise to see how well it works compared with normal care in overweight or obese women who have undergone treatment for stage I, stage II, or stage III breast cancer.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 4, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Last Updated

August 26, 2013

Status Verified

December 1, 2009

Enrollment Period

2.7 years

First QC Date

June 3, 2008

Last Update Submit

August 23, 2013

Conditions

Breast Cancer

Keywords

stage IA breast cancerstage IB breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancer

Outcome Measures

Primary Outcomes (2)

  • Body weight

  • Body composition

Secondary Outcomes (4)

  • Pychological stress via the Perceived Stress Scale

  • Depression via the Beck Depression Inventory II

  • Cardiorespiratory fitness

  • Quality of life via the FACT-G and FACT-B

Interventions

behavioral dietary interventionBEHAVIORAL
exercise interventionBEHAVIORAL
counseling interventionOTHER
flow cytometryOTHER
immunoenzyme techniqueOTHER
laboratory biomarker analysisOTHER
complementary or alternative medicine procedurePROCEDURE
standard follow-up carePROCEDURE

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of stage I, II, or III breast cancer * No metastatic breast cancer * No inoperable or active loco-regional disease * Body mass index (BMI) \> 25 * Patients must have completed treatment for breast cancer within the past 3-18 months * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Female * Menopausal status not specified * Willing and able to attend supervised exercise sessions at least 3 times per week for a period of 24 weeks * Patients must be an exercise pre-contemplator, contemplator, or preparer as defined by the transtheoretical model * No physical/psychiatric impairment that would seriously impair physical mobility * No severe nausea, anorexia, or other diseases affecting health (e.g., arthritis and multiple sclerosis) * More than 3 months since prior exercise and not currently engaged in exercise (two or more times per week for at least 30 minutes per session) PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Concurrent tamoxifen, other endocrine treatments, and trastuzumab (Herceptin®) allowed * No concurrent alternative/complementary diets * No concurrent high-dose antioxidant supplement therapy * More than 4 months since prior and no concurrent hormone-replacement therapy or oral contraceptives

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Sheffield Hallam University - City Campus

Sheffield, England, S1O 2JF, United Kingdom

Location

Related Publications (1)

  • 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 Feb 9;6:35. doi: 10.1186/1471-2407-6-35.

    PMID: 16469108RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

CounselingFlow CytometryImmunoenzyme Techniques

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesCell SeparationCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisCytophotometryFluorometryLuminescent MeasurementsPhotometryChemistry Techniques, AnalyticalInvestigative TechniquesImmunoassayImmunologic TechniquesImmunohistochemistryMolecular Probe Techniques

Study Officials

  • John M. Saxton, PhD

    Royal Hallamshire Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 3, 2008

First Posted

June 4, 2008

Study Start

February 1, 2006

Primary Completion

October 1, 2008

Last Updated

August 26, 2013

Record last verified: 2009-12

Locations

GB(1)