Diet and Exercise or Normal Care in Overweight or Obese Women Who Have Undergone Treatment for Stage I, Stage II, or Stage III Breast Cancer

August 23, 2013 updated by: Sheffield Hallam University

The Effects of a Combined Diet and Exercise Intervention on Biomarkers Associated With Disease Recurrence After Breast Cancer Treatment: The Sheffield DEBRA Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • To examine the effects of a dietary and exercise intervention on body weight and body composition in overweight or obese women who have undergone breast cancer treatment.
  • To examine the effects of a dietary and exercise intervention on indices of psychological health status and biomarkers associated with disease recurrence in overweight or obese women who have undergone breast cancer treatment.

Secondary

  • To examine the relationship between change in body weight and biomarkers associated with disease recurrence and physiological health status, including circulating levels of estrogen, C-reactive protein, and interleukin-6.
  • To examine the relationship between changes in psychological health status, circulating stress hormones, and indices of immune function.
  • To examine the effects of the dietary and exercise intervention on broader quality-of-life dimensions.

OUTLINE: Patients are randomized to one of intervention arms.

  • Arm I (lifestyle intervention): Patients undergo moderate-intensity aerobic-exercise sessions 3 to 5 days a week for 24 weeks. Patients not able to attend five supervised sessions are counseled on how they can fit an extra 1-2 home/community-based exercise sessions into their weekly routine. All sessions of physical activity are recorded in a physical activity log. Portable pedometers are used to determine the number of steps/distance walked each day. Patients wear heart-rate monitors throughout the exercise sessions. Heart rate and ratings of perceived exertion are assessed at regular intervals. The exercise-therapy sessions use a variety of cognitive-behavioral techniques for promoting exercise adherence as well as positive attitudes and experiences.

Patients are also given individualized healthy-eating dietary advice and written information packet named ' Weight Loss On A Plate'. Patients are also counseled on how to reduce their dietary fat intake to 25% of total caloric intake, eating at least 5 portions of fruit and vegetables daily, increasing fiber intake, reducing carbohydrates, and taking moderate amounts of alcohol. Patients are also counseled on how to reduce their total daily calorie intake to 600 kcal below their calculated energy requirements. Individual energy requirements will be estimated from a formula of basal metabolic rate and physical activity level. Patients complete a 3-day diet diary prior to beginning study treatment and then weekly throughout the study. The diaries from pre-intervention and from weeks 6, 12, 18, and 24 are analyzed, looking specifically at macronutrients. Patients meet with the research assistant once weekly to discuss their individual diet diaries and identify ways in which they can further improve their nutritional intake.

  • Arm II (normal care): Patients are provided with a general healthy-eating booklet entitled, "Getting the Balance Right".

Depression, psychological stress, and quality of life are assessed at baseline and then at 12 weeks, and 25 weeks.

Blood samples are examined for various biomarkers including interleukin-6 by ELISA, estradiol by radioimmunoassay, and for lymphocyte phenotyping and NK-cell activity by flow cytometry.

Salivary cortisol levels are measured 4 times on two consecutive days by high-sensitivity salivary cortisol enzyme immunoassay.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Sheffield, England, United Kingdom, S1O 2JF
        • Sheffield Hallam University - City Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Body weight
Body composition

Secondary Outcome Measures

Outcome Measure
Cardiorespiratory fitness
Pychological stress via the Perceived Stress Scale
Depression via the Beck Depression Inventory II
Quality of life via the FACT-G and FACT-B

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheffield Hallam University

Investigators

  • Principal Investigator: John M. Saxton, PhD, Royal Hallamshire Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

June 3, 2008

First Submitted That Met QC Criteria

June 3, 2008

First Posted (Estimate)

June 4, 2008

Study Record Updates

Last Update Posted (Estimate)

August 26, 2013

Last Update Submitted That Met QC Criteria

August 23, 2013

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000588427
  • SHU-USMS-DEBRA
  • ISRCTN08045231
  • EU-20821

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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