Breast CancerNCT00533338
Weight Gain Prevention for Breast Cancer Survivors
A study testing Weight Gain Prevention Program and Questionnaire in people with Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The specific aims of this study are: 1. To test the feasibility of a randomized controlled trial of a weight gain prevention program for breast cancer survivors that combines exercise and dietary changes during treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Weight Gain Prevention Program and Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2007to 31 Jul 2020
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman with newly diagnosed stage II or III breast cancer.
- Over 18 years of age.
- Beginning neo-adjuvant chemotherapy at M. D. Anderson (no more than 3 weeks from the administration of the first cycle).
- Speaks and reads English.
- Oriented to person, place, and time.
- Able to come to M. D. Anderson once a week for intervention.
- Has physician clearance to engage in moderate physical activity.
- Lives in Harris County, Texas or a county contiguous to Harris County, Texas.
Who cannot join
- Have any of the following conditions defined by the American College of Sports Medicine as absolute contraindications to exercise testing (a recent significant change in the resting ECG suggesting significant ischemia, recent myocardial infarction (within 2 days) or acute cardiac event; unstable angina; uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise; severe symptomatic aortic stenosis; uncontrolled symptomatic heart failure; acute pulmonary embolus or pulmonary infarction; acute myocarditis or pericarditis; suspected or known dissecting aneurysm; acute infection).
- Have any of the following conditions as defined by the American College of Sports Medicine as relative contraindications to exercise testing (left main coronary stenosis; moderate stenotic valvular heart disease; electrolyte abnormalities; severe arterial hypertension at rest; hypertrophic cardiomyopathy and other forms of outflow tract obstruction; neuromuscular, musculoskeletal, or rheumatoid disorders that are exacerbated by exercise; high-degree atrioventricular block; ventricular aneurysm; uncontrolled metabolic disease; chronic infectious disease).
- Right or left bundle branch block.
- Baseline ST segment or T wave changes that would make monitoring of the ECG stress test indeterminate.
- Uncontrolled asthma.
- Have other medical contraindications as defined by the patient's physician.
- Have inflammatory breast cancer.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
The specific aims of this study are:
- To test the feasibility of a randomized controlled trial of a weight gain prevention program for breast cancer survivors that combines exercise and dietary changes during treatment. Feasibility will be evaluated by examining data on recruitment rate, attendance at intervention sessions, drop-out rates in both study conditions, assessment completion rates, and participant feedback.
- To test the effect of a weight gain prevention program, compared to usual care, on weight, body composition, and biomarkers related to breast cancer prognosis.
- To explore whether changes in physical activity, energy intake, and resting energy expenditure predict weight gain among breast cancer survivors.
- To test the effect of a weight gain prevention program on quality of life variables.
Read the detailed description
Women who are breast cancer patients having chemotherapy before surgery will be invited to participate in the study. You will be allowed to participate in this study only if your physician feels it is safe for you to participate in moderate physical activity, so you will be asked to have him or her complete a form about your health conditions. Information about the cancer and your treatment history will be obtained from your medical records as part of the study.
If you agree to take part in this study, you will asked to come in for 2 visits at the beginning of the study. At your first visit, your resting energy expenditure (REE) will be measured. To test your REE, you will lie down on a bed while wearing a mask to measure the air you let out when you breathe. You will have an electrocardiogram (ECG -- a test that measures the electrical activity of the heart). Blood (about 2 teaspoons) will be drawn to measure biomarkers, that may affect breast cancer. You will receive a packet of quality of life questionnaires which will take 45 minutes to complete. You will also receive an actigraph (a small, light-weight device that is worn on the waist during the day) that provides researchers with information on your physical activity. You will be asked to wear the actigraph for 7 days before your second visit. You will be given a diet questionnaire to complete at home. The diet questionnaire will take 60 minutes to complete. You will be asked to bring the actigraph and questionnaires to a baseline study visit.
At the second study visit you will also complete questionnaires about your physical activity.
Your blood pressure and heart rate will be measured. Your physical fitness will be checked by an exercise test done on a treadmill. The exercise test will be monitored by a qualified health care provider and performed by a certified exercise specialist with training in emergency procedures. The exercise intensity will begin at a low level and will be increased over time. The test may be stopped at any time if you experience signs of fatigue or changes in your heart rate, ECG, or blood pressure. You may also stop the test whenever you wish.
Your height, weight, skinfolds, and hip and waist circumference will be measured. Your arm, shoulder, and leg strength will be checked by asking you to stand on a platform and grasp a bar connected to a strain gauge that measures force. Your hip and lower back flexibility will checked using a 'sit and reach' method. Flexibility in your arm will be checked using a goniometer, a small plastic measuring device similar to a ruler.
You will be given a packet of 10 collection tubes for collecting saliva samples with instruction on collecting the samples over 2 days during the next week. You will also be given a special mailer with which to return the samples. The second study visit will take about 2 hours.
After your initial visit, you will be asked to come to M. D. Anderson to complete a Dual energy x-ray absorptiometry (DEXA) scan to evaluate body composition.
At your baseline study visit, you will be randomly assigned (as in the toss of a coin) to either a weight gain prevention group or a standard of care group. An equal number of people will be assigned to each group.
If you are assigned to the intervention group, you will attend individual in-person study visits at M. D. Anderson to receive instruction and counseling about exercise and diet.
While you are receiving chemotherapy, you will attend 1, 60-minute study visit per week for 16 weeks. During these visits, you will be given instructions on resistance and flexibility exercises, using a pedometer (a small device that is worn during the day to give you information about the number of steps you take), and making changes in your diet. You will practice the exercises during this session, and receive feedback. Some of these session might be video taped. You will be asked to give permission for the videotaping before the session begins.
After the 16 weeks of in-person sessions, you will receive 1 telephone counseling session per week for the remainder of the time you are on chemotherapy. Each telephone call will take about 15-20 minutes. Some of these sessions might be tape-recorded. You will be asked permission to tape-record the session before the telephone counseling session is begun. You will receive written materials about making changes to your diet and exercise behavior. The written materials will have information about overcoming barriers, rewarding yourself, and time management. You will also receive hand weights, a step, and a stability ball for exercising at home and a pedometer for monitoring your walking. The hand weights, step, stability ball, and pedometer will be yours to keep. Based on the strength assessment, tailored resistance exercises will be prescribed. You will do the exercises up to 3 times per week. The exercise will target the major muscle groups.
After you have recovered from surgery, you will have 1 study visit a week for 3 weeks. You will practice the exercises and again receive counseling to encourage you to exercise and to eat according to your dietary recommendations. The exercises may be modified at this visit, if necessary.
After these 3 weeks, you will receive 1 phone call a week for the next 6 weeks. Each telephone call will take about 15-20 minutes. You will also receive additional written materials that will include exercises and recommendations for maintaining the behavioral changes made.
Regardless of which group you are in, you will be asked to come to M. D. Anderson for follow-up assessments at the mid-point and end of chemotherapy, after recovering from surgery, then 9 weeks and 6 months after surgery. You will be asked to come to M. D. Anderson to complete a DEXA scan to evaluate body composition and bone mineral density at the end of chemotherapy. For safety purposes, researchers will look for lymphedema at follow-up evaluations after recovering from surgery, then 9 weeks and 6 months after surgery. About 8 days before each follow-up visit we will send you a packet of seven questionnaires that will take 45 minutes to complete, and an actigraph. You will be called on the day you are supposed to wear the actigraph, and you will be given instructions about completing the questionnaires. You will bring the questionnaires and actigraph to your study visits. You will have the same tests and procedures at these study visits as you had at the baseline visit.
You will be considered off-study 6 months after your surgery.
This is an investigational study. About 60 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Breast Cancer
- Being tested
- Weight Gain Prevention Program, Questionnaire
- Keywords
- Breast Cancer, Cancer Survivors, Weight Gain Prevention, Diet, Exercise, Questionnaire, Survey
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight Gain Prevention ProgramBehavioural
Intervention program including in-person instruction and counseling about exercise and diet, exercise practice sessions, and telephone counseling.
QuestionnaireBehavioural
Also called Survey
Packet of questionnaires will be completed.
| Study group | Role | What they receive |
|---|---|---|
| Weight Gain Prevention Program | Experimental | Intervention program including in-person instruction and counseling about exercise and diet, exercise practice sessions, and telephone counseling. Packet of questionnaires will be completed. Receives: Behavioral: Weight Gain Prevention Program; Behavioral: Questionnaire |
| Standard Care Group | Active comparator | Packet of questionnaires will be completed. Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight or Percentage (%) Body Fat
Measured: Six assessments: baseline, 3 months after starting chemotherapy, at the end of chemotherapy, after recovery from surgery, at the end of the 9-week booster intervention, and 6 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2007 (estimated)
- Study start20 Jul 2007
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
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.
- More trials run by M.D. Anderson 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Lance Armstrong Foundation
- Responsible party
- Sponsor
- Investigators
- Karen Basen-Engquist, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00533338
- Sponsor's protocol ID
- 2005-0888
- Status last verified
- Jan 2020
- First submitted
- 19 Sep 2007
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Basen-Engquist KM, Raber M, Carmack CL, Arun B, Brewster AM, Fingeret M, Schembre SM, Harrison C, Perkins HY, Li Y, Song J, Chen M, Murray JL. Feasibility and efficacy of a weight gain prevention intervention for breast cancer patients receiving neoadjuvant chemotherapy: a randomized controlled pilot study. Support Care Cancer. 2020 Dec;28(12):5821-5832. doi: 10.1007/s00520-020-05411-2. Epub 2020 Apr 5.
PubMed 32249355
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Gain Prevention for Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT00533338
- Acronym / sponsor ID
- 2005-0888
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Cancer Survivors, Weight Gain Prevention, Diet, Exercise, Questionnaire, Survey
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Lance Armstrong Foundation
- Study start
- 20 Jul 2007 (actual)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 21 Sep 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.
The specific aims of this study are:
- To test the feasibility of a randomized controlled trial of a weight gain prevention program for breast cancer survivors that combines exercise and dietary changes during treatment. Feasibility will be evaluated by examining data on recruitment rate, attendance at intervention sessions, drop-out rates in both study conditions, assessment completion rates, and participant feedback.
- To test the effect of a weight gain prevention program, compared to usual care, on weight, body composition, and biomarkers related to breast cancer prognosis.
- To explore whether changes in physical activity, energy intake, and resting energy expenditure predict weight gain among breast cancer survivors.
- To test the effect of a weight gain prevention program on quality of life variables.
Detailed description
Women who are breast cancer patients having chemotherapy before surgery will be invited to participate in the study. You will be allowed to participate in this study only if your physician feels it is safe for you to participate in moderate physical activity, so you will be asked to have him or her complete a form about your health conditions. Information about the cancer and your treatment history will be obtained from your medical records as part of the study.
If you agree to take part in this study, you will asked to come in for 2 visits at the beginning of the study. At your first visit, your resting energy expenditure (REE) will be measured. To test your REE, you will lie down on a bed while wearing a mask to measure the air you let out when you breathe. You will have an electrocardiogram (ECG -- a test that measures the electrical activity of the heart). Blood (about 2 teaspoons) will be drawn to measure biomarkers, that may affect breast cancer. You will receive a packet of quality of life questionnaires which will take 45 minutes to complete. You will also receive an actigraph (a small, light-weight device that is worn on the waist during the day) that provides researchers with information on your physical activity. You will be asked to wear the actigraph for 7 days before your second visit. You will be given a diet questionnaire to complete at home. The diet questionnaire will take 60 minutes to complete. You will be asked to bring the actigraph and questionnaires to a baseline study visit.
At the second study visit you will also complete questionnaires about your physical activity.
Your blood pressure and heart rate will be measured. Your physical fitness will be checked by an exercise test done on a treadmill. The exercise test will be monitored by a qualified health care provider and performed by a certified exercise specialist with training in emergency procedures. The exercise intensity will begin at a low level and will be increased over time. The test may be stopped at any time if you experience signs of fatigue or changes in your heart rate, ECG, or blood pressure. You may also stop the test whenever you wish.
Your height, weight, skinfolds, and hip and waist circumference will be measured. Your arm, shoulder, and leg strength will be checked by asking you to stand on a platform and grasp a bar connected to a strain gauge that measures force. Your hip and lower back flexibility will checked using a 'sit and reach' method. Flexibility in your arm will be checked using a goniometer, a small plastic measuring device similar to a ruler.
You will be given a packet of 10 collection tubes for collecting saliva samples with instruction on collecting the samples over 2 days during the next week. You will also be given a special mailer with which to return the samples. The second study visit will take about 2 hours.
After your initial visit, you will be asked to come to M. D. Anderson to complete a Dual energy x-ray absorptiometry (DEXA) scan to evaluate body composition.
At your baseline study visit, you will be randomly assigned (as in the toss of a coin) to either a weight gain prevention group or a standard of care group. An equal number of people will be assigned to each group.
If you are assigned to the intervention group, you will attend individual in-person study visits at M. D. Anderson to receive instruction and counseling about exercise and diet.
While you are receiving chemotherapy, you will attend 1, 60-minute study visit per week for 16 weeks. During these visits, you will be given instructions on resistance and flexibility exercises, using a pedometer (a small device that is worn during the day to give you information about the number of steps you take), and making changes in your diet. You will practice the exercises during this session, and receive feedback. Some of these session might be video taped. You will be asked to give permission for the videotaping before the session begins.
After the 16 weeks of in-person sessions, you will receive 1 telephone counseling session per week for the remainder of the time you are on chemotherapy. Each telephone call will take about 15-20 minutes. Some of these sessions might be tape-recorded. You will be asked permission to tape-record the session before the telephone counseling session is begun. You will receive written materials about making changes to your diet and exercise behavior. The written materials will have information about overcoming barriers, rewarding yourself, and time management. You will also receive hand weights, a step, and a stability ball for exercising at home and a pedometer for monitoring your walking. The hand weights, step, stability ball, and pedometer will be yours to keep. Based on the strength assessment, tailored resistance exercises will be prescribed. You will do the exercises up to 3 times per week. The exercise will target the major muscle groups.
After you have recovered from surgery, you will have 1 study visit a week for 3 weeks. You will practice the exercises and again receive counseling to encourage you to exercise and to eat according to your dietary recommendations. The exercises may be modified at this visit, if necessary.
After these 3 weeks, you will receive 1 phone call a week for the next 6 weeks. Each telephone call will take about 15-20 minutes. You will also receive additional written materials that will include exercises and recommendations for maintaining the behavioral changes made.
Regardless of which group you are in, you will be asked to come to M. D. Anderson for follow-up assessments at the mid-point and end of chemotherapy, after recovering from surgery, then 9 weeks and 6 months after surgery. You will be asked to come to M. D. Anderson to complete a DEXA scan to evaluate body composition and bone mineral density at the end of chemotherapy. For safety purposes, researchers will look for lymphedema at follow-up evaluations after recovering from surgery, then 9 weeks and 6 months after surgery. About 8 days before each follow-up visit we will send you a packet of seven questionnaires that will take 45 minutes to complete, and an actigraph. You will be called on the day you are supposed to wear the actigraph, and you will be given instructions about completing the questionnaires. You will bring the questionnaires and actigraph to your study visits. You will have the same tests and procedures at these study visits as you had at the baseline visit.
You will be considered off-study 6 months after your surgery.
This is an investigational study. About 60 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight Gain Prevention Program | Experimental | Behavioral: Weight Gain Prevention Program, Behavioral: QuestionnaireIntervention program including in-person instruction and counseling about exercise and diet, exercise practice sessions, and telephone counseling. Packet of questionnaires will be completed. |
| Standard Care Group | Active comparator | Behavioral: QuestionnairePacket of questionnaires will be completed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Woman with newly diagnosed stage II or III breast cancer.
- Over 18 years of age.
- Beginning neo-adjuvant chemotherapy at M. D. Anderson (no more than 3 weeks from the administration of the first cycle).
- Speaks and reads English.
- Oriented to person, place, and time.
Key exclusion criteria (7 listed)
- Have any of the following conditions defined by the American College of Sports Medicine as absolute contraindications to exercise testing (a recent significant change in the resting ECG suggesting significant ischemia, recent myocardial infarction (within 2 days) or acute cardiac event; unstable angina; uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise; severe symptomatic aortic stenosis; uncontrolled symptomatic heart failure; acute pulmonary embolus or pulmonary infarction; acute myocarditis or pericarditis; suspected or known dissecting aneurysm; acute infection).
- Have any of the following conditions as defined by the American College of Sports Medicine as relative contraindications to exercise testing (left main coronary stenosis; moderate stenotic valvular heart disease; electrolyte abnormalities; severe arterial hypertension at rest; hypertrophic cardiomyopathy and other forms of outflow tract obstruction; neuromuscular, musculoskeletal, or rheumatoid disorders that are exacerbated by exercise; high-degree atrioventricular block; ventricular aneurysm; uncontrolled metabolic disease; chronic infectious disease).
- Right or left bundle branch block.
- Baseline ST segment or T wave changes that would make monitoring of the ECG stress test indeterminate.
- Uncontrolled asthma.
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 |
|---|---|---|
| Weight Gain Prevention ProgramIntervention program including in-person instruction and counseling about exercise and diet, exercise practice sessions, and telephone counseling. | Behavioural | Weight Gain Prevention Program |
| QuestionnaireAlso: SurveyPacket of questionnaires will be completed. | Behavioural | Standard Care Group, Weight Gain Prevention Program |
Primary outcome
Weight or Percentage (%) Body Fat
Time frame: Six assessments: baseline, 3 months after starting chemotherapy, at the end of chemotherapy, after recovery from surgery, at the end of the 9-week booster intervention, and 6 months after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Derived from this study: PubMed 32249355Basen-Engquist KM, Raber M, Carmack CL, Arun B, Brewster AM, Fingeret M, Schembre SM, Harrison C, Perkins HY, Li Y, Song J, Chen M, Murray JL. Feasibility and efficacy of a weight gain prevention intervention for breast cancer patients receiving neoadjuvant chemotherapy: a randomized controlled pilot study. Support Care Cancer. 2020 Dec;28(12):5821-5832. doi: 10.1007/s00520-020-05411-2. Epub 2020 Apr 5.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Karen Basen-Engquist, PhD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight Gain Prevention Program and Questionnaire in people with Breast Cancer, run by M.D. Anderson 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 8 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 13 Jan 2020. 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.
Are results available for this study?
Results are not available in the source record.
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?
Weight or Percentage (%) Body Fat (time frame: Six assessments: baseline, 3 months after starting chemotherapy, at the end of chemotherapy, after recovery from surgery, at the end of the 9-week booster intervention, and 6 months after surgery.). 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 NCT00533338, 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 13 Jan 2020.