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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN08045231
Enrollment
100
Registered
2005-10-25
Start date
2005-10-01
Completion date
Unknown
Last updated
2022-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer Cancer Breast

Interventions

Exercise and dietary intervention versus no intervention.

Sponsors

Sheffield Hallam University (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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 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

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
Body weight; body composition.

Secondary

MeasureTime frame
Psychological health status; biomarkers associated with disease recurrence (including stress hormones, immune function, inflammatory mediators); quality of life; cardiovascular fitness.

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 7, 2026