Breast CancerPhase 1/2NCT00509626
Physical Activity or Usual Care in Preventing Weight Gain in Women With Stage I or Stage II Breast Cancer Undergoing Chemotherapy
A Phase 1/2 study testing exercise intervention, questionnaire administration and CAM exercise therapy in people with Breast Cancer and Depression, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Physical activity may prevent or reduce weight gain in women receiving chemotherapy for early stage breast cancer. PURPOSE: This randomized phase I/II trial is studying physical activity to see how well it works compared with usual care to prevent or reduce weight gain in women with stage I or stage II… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Depression, Fatigue
- What is being tested?
- exercise intervention, questionnaire administration and CAM exercise therapy
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 380 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jul 2008
- Phase
- Phase 1/2
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of primary breast cancer
- Newly diagnosed stage I or II disease
- Receiving care at a participating Fox Chase Cancer Center CCOP Research Base (FCRB) member site
- Geisinger Clinic and Medical Center (phase I)
- Main Line Health (phase I)
- Any of the other participating FCRB member sites (phase II)
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- Study intervention is scheduled to begin anytime after surgery up to 3 months after completion of adjuvant chemotherapy
- Treatment plan includes adjuvant chemotherapy
- Hormone receptor status not specified
- Female
- Premenopausal or postmenopausal
- Has obtained medical clearance by oncologist and breast surgeon to participate in this study
- Body mass index ≥ 20 kg/m^2 and < 39 kg/m^2
Who cannot join
- Treatment plan includes trastuzumab (Herceptin®) or bevacizumab
- Recurrent breast cancer
- PATIENT CHARACTERISTICS:
- Hemoglobin < 12 g/dL
- ANC < 1,500/mm^3
- Any medical condition that restricts participation in a physical activity program (e.g., exercise-induced angina, uncontrolled hypertension, dementia, or a major psychological problem)
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- Answers "yes" to any questions on the Physical Activity Readiness Questionnaire (PAR-Q) and PAR-Q not reviewed by a physician who subsequently approves participation in the physical activity intervention
- Known to be pregnant or breastfeeding
- Unwilling to commit or unable to participate in a 6-month physical activity intervention (unable to exercise, usually travels away from home overnight more than once per week, and/or has plans to be away from home for more than two weeks in the next 6 months)
- Previously diagnosed with another primary cancer other than basal cell or squamous cell carcinoma of the skin
- Exercising regularly prior to intervention (i.e., reports current participation in vigorous or moderate activity at least 3 days per week for at least 30 minutes each day on the International Physical Activity Questionnaire)
- Unable to speak and read English
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No neoadjuvant chemotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, 19111-2497
About this study
Official title: A Physical Activity Intervention to Prevent Weight Gain in Breast Cancer Patients
RATIONALE: Physical activity may prevent or reduce weight gain in women receiving chemotherapy for early stage breast cancer.
PURPOSE: This randomized phase I/II trial is studying physical activity to see how well it works compared with usual care to prevent or reduce weight gain in women with stage I or stage II breast cancer undergoing chemotherapy.
Read the detailed description
OBJECTIVES:
Primary
- Determine the feasibility for conducting a clinical trial that uses a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer and prior to initiation of adjuvant chemotherapy, hormonal therapy, and/or radiotherapy. (phase I)
- Determine if participation in a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer decreases weight gain in patients treated with adjuvant chemotherapy. (phase II)
- Determine if participation in a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer differentially affects weight change in women who are premenopausal compared to those who are postmenopausal at diagnosis. (phase II)
Secondary
- Determine if participation in a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer decreases gains in adiposity in patients treated with adjuvant chemotherapy. (phase II)
- Determine if participation in a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer differentially affects change in adiposity among women who are premenopausal compared to those who are postmenopausal at diagnosis. (phase II)
- Determine if participation in a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer decreases the frequency of depressive symptomology and improves quality of life among patients treated with adjuvant chemotherapy. (phase II)
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating site and menopausal status (premenopausal vs postmenopausal). Patients are randomized to 1 of 2 intervention arms.
- Arm I (exercise and usual care): Patients receive usual care and are enrolled in an exercise and weight control program at Curves® fitness center. The Curves® program, which begins during the third week of study, uses aerobic activity and resistance training to reduce weight and increase strength and fitness. Patients exercise a minimum of 3 times per week, approximately 30 minutes every time, for up to 6 months in the absence of disease progression or unacceptable toxicity. Patients' physical activity is measured at baseline and at the 3- and 6-month follow-up visits.
Patients also undergo behavior modification counseling with a study nurse to help them overcome the specific barriers to adhering to the recommended exercise routine. Counseling sessions are conducted every 2 to 3 weeks during chemotherapy and at least monthly after completion of chemotherapy for up to 6 months, starting within 2 weeks after randomization and prior to initiation of the Curves® intervention.
- Arm II (control: usual care alone): Patients receive usual care and general advice on coping with their breast cancer treatment for up to 6 months in the absence of disease progression or unacceptable toxicity. Patients receive no counseling or recommendations concerning emotional and practical barriers encountered during breast cancer treatment.
Dietary information is obtained from patients by telephone during three 24-hour dietary recalls performed within 2 weeks of baseline and at the 3-month and 6-month follow-up visits to estimate total energy intake throughout the study. Patients complete questionnaires at baseline and periodically during study assessing demographic characteristics and established breast cancer risk factors, medical history, and health changes. Weight, adiposity as measured by waist circumference, quality of life, and depressive symptomology are assessed at baseline and at the 3- and 6-month follow-up visits.
After completion of the study intervention, patients are followed for up to 6 months.
- Conditions
- Breast Cancer, Depression, Fatigue, Psychosocial Effects of Cancer and Its Treatment, Weight Changes
- Being tested
- exercise intervention, questionnaire administration, CAM exercise therapy, management of therapy complications, psychosocial assessment and care
- Keywords
- fatigue, psychosocial effects of cancer and its treatment, weight changes, depression, stage I breast cancer, stage II breast cancer
- Medical subject headings
- Breast Neoplasms, Depression, Fatigue, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise interventionBehavioural
questionnaire administrationOther
CAM exercise therapyProcedure or surgery
management of therapy complicationsProcedure or surgery
psychosocial assessment and careProcedure or surgery
quality-of-life assessmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Accrual (phase I)
Retention (phase I)
Weight change after 6 months (phase II)
Secondary outcomes (3)
Adiposity as measured by waist circumference at 3 and 6 months
Health-related quality of life as measured by the Short-Form Health Survey-12 Physical and Mental Component Summary scales
Depressive symptomology as measured by the Center for Epidemiologic Studies Depression Scale
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2007 (estimated)
- Study startJun 2007
- Primary completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Penny Anderson, MD, Study chair, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00509626
- Sponsor's protocol ID
- CDR0000555830
- Other IDs
- P30CA006927, FCCC-FCRB-05-009
- Status last verified
- Feb 2010
- First submitted
- 30 Jul 2007
- Last updated
- 12 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Physical Activity Intervention to Prevent Weight Gain in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00509626
- Acronym / sponsor ID
- CDR0000555830
- Conditions
- Breast Cancer, Depression, Fatigue, Psychosocial Effects of Cancer and Its Treatment, Weight Changes
- Keywords
- fatigue, psychosocial effects of cancer and its treatment, weight changes, depression, stage I breast cancer, stage II breast cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2007
- Primary completion
- Jul 2008 (actual)
- First posted
- 31 Jul 2007 (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: Physical activity may prevent or reduce weight gain in women receiving chemotherapy for early stage breast cancer.
PURPOSE: This randomized phase I/II trial is studying physical activity to see how well it works compared with usual care to prevent or reduce weight gain in women with stage I or stage II breast cancer undergoing chemotherapy.
Detailed description
OBJECTIVES:
Primary
- Determine the feasibility for conducting a clinical trial that uses a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer and prior to initiation of adjuvant chemotherapy, hormonal therapy, and/or radiotherapy. (phase I)
- Determine if participation in a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer decreases weight gain in patients treated with adjuvant chemotherapy. (phase II)
- Determine if participation in a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer differentially affects weight change in women who are premenopausal compared to those who are postmenopausal at diagnosis. (phase II)
Secondary
- Determine if participation in a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer decreases gains in adiposity in patients treated with adjuvant chemotherapy. (phase II)
- Determine if participation in a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer differentially affects change in adiposity among women who are premenopausal compared to those who are postmenopausal at diagnosis. (phase II)
- Determine if participation in a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer decreases the frequency of depressive symptomology and improves quality of life among patients treated with adjuvant chemotherapy. (phase II)
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating site and menopausal status (premenopausal vs postmenopausal). Patients are randomized to 1 of 2 intervention arms.
- Arm I (exercise and usual care): Patients receive usual care and are enrolled in an exercise and weight control program at Curves® fitness center. The Curves® program, which begins during the third week of study, uses aerobic activity and resistance training to reduce weight and increase strength and fitness. Patients exercise a minimum of 3 times per week, approximately 30 minutes every time, for up to 6 months in the absence of disease progression or unacceptable toxicity. Patients' physical activity is measured at baseline and at the 3- and 6-month follow-up visits.
Patients also undergo behavior modification counseling with a study nurse to help them overcome the specific barriers to adhering to the recommended exercise routine. Counseling sessions are conducted every 2 to 3 weeks during chemotherapy and at least monthly after completion of chemotherapy for up to 6 months, starting within 2 weeks after randomization and prior to initiation of the Curves® intervention.
- Arm II (control: usual care alone): Patients receive usual care and general advice on coping with their breast cancer treatment for up to 6 months in the absence of disease progression or unacceptable toxicity. Patients receive no counseling or recommendations concerning emotional and practical barriers encountered during breast cancer treatment.
Dietary information is obtained from patients by telephone during three 24-hour dietary recalls performed within 2 weeks of baseline and at the 3-month and 6-month follow-up visits to estimate total energy intake throughout the study. Patients complete questionnaires at baseline and periodically during study assessing demographic characteristics and established breast cancer risk factors, medical history, and health changes. Weight, adiposity as measured by waist circumference, quality of life, and depressive symptomology are assessed at baseline and at the 3- and 6-month follow-up visits.
After completion of the study intervention, patients are followed for up to 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Diagnosis of primary breast cancer
- Receiving care at a participating Fox Chase Cancer Center CCOP Research Base (FCRB) member site
- Study intervention is scheduled to begin anytime after surgery up to 3 months after completion of adjuvant chemotherapy
- Treatment plan includes adjuvant chemotherapy
- Hormone receptor status not specified
Key exclusion criteria (15 listed)
- Treatment plan includes trastuzumab (Herceptin®) or bevacizumab
- Recurrent breast cancer
- Hemoglobin < 12 g/dL
- ANC < 1,500/mm^3
- Any medical condition that restricts participation in a physical activity program (e.g., exercise-induced angina, uncontrolled hypertension, dementia, or a major psychological problem)
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 |
|---|---|---|
| exercise intervention | Behavioural | – |
| questionnaire administration | Other | – |
| CAM exercise therapy | Procedure or surgery | – |
| management of therapy complications | Procedure or surgery | – |
| psychosocial assessment and care | Procedure or surgery | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Accrual (phase I)
Retention (phase I)
Weight change after 6 months (phase II)
3 secondary outcomes
Adiposity as measured by waist circumference at 3 and 6 months
Health-related quality of life as measured by the Short-Form Health Survey-12 Physical and Mental Component Summary scales
Depressive symptomology as measured by the Center for Epidemiologic Studies Depression Scale
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 12 Feb 2010.
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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.
Penny Anderson, MD study chair
Fox Chase Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing exercise intervention, questionnaire administration and CAM exercise therapy in people with Breast Cancer and Depression, run by Fox Chase Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2010. 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 States. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Accrual (phase I). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2010.