Breast CancerNCT00689975
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
A study testing behavioral dietary intervention, exercise intervention and counseling intervention in people with Breast Cancer, run by Sheffield Hallam University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- behavioral dietary intervention, exercise intervention and counseling intervention
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2006to Oct 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Hallam University - City Campus
Sheffield, England, S1O 2JF
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- behavioral dietary intervention, exercise intervention, counseling intervention, flow cytometry, immunoenzyme technique
- Keywords
- stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral dietary interventionBehavioural
exercise interventionBehavioural
counseling interventionOther
flow cytometryOther
immunoenzyme techniqueOther
laboratory biomarker analysisOther
complementary or alternative medicine procedureProcedure or surgery
standard follow-up careProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2008 (estimated)
- Study startFeb 2006
- Primary completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Hallam University
- Sponsor type
- University, hospital or other
- Investigators
- John M. Saxton, PhD, Principal investigator, Royal Hallamshire Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00689975
- Sponsor's protocol ID
- CDR0000588427
- Other IDs
- SHU-USMS-DEBRA, ISRCTN08045231, EU-20821
- Status last verified
- Dec 2009
- First submitted
- 3 Jun 2008
- Last updated
- 26 Aug 2013
- Results posted
- No
Publications
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.
PubMed 16469108
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Combined Diet and Exercise Intervention on Biomarkers Associated With Disease Recurrence After Breast Cancer Treatment: The Sheffield DEBRA Trial
- ClinicalTrials.gov ID
- NCT00689975
- Acronym / sponsor ID
- CDR0000588427
- Conditions
- Breast Cancer
- Keywords
- stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sheffield Hallam UniversityUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Oct 2008 (actual)
- First posted
- 4 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Randomised
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| behavioral dietary intervention | Behavioural | – |
| exercise intervention | Behavioural | – |
| counseling intervention | Other | – |
| flow cytometry | Other | – |
| immunoenzyme technique | Other | – |
| laboratory biomarker analysis | Other | – |
| complementary or alternative medicine procedure | Procedure or surgery | – |
| standard follow-up care | Procedure or surgery | – |
Primary outcome
Body weight
Body composition
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
- Results publication: PubMed 16469108Saxton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John M. Saxton, PhD principal investigator
Royal Hallamshire Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing behavioral dietary intervention, exercise intervention and counseling intervention in people with Breast Cancer, run by Sheffield Hallam University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00689975, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2013.