DepressionNCT00019643
Factors Affecting Weight Gain in Women Receiving Adjuvant Chemotherapy for Breast Cancer
An observational study of Depression and Stage I Breast Cancer, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
RATIONALE: Chemotherapy may affect various factors that can lead to weight gain. PURPOSE: Clinical trial to evaluate factors that may affect weight gain in women receiving adjuvant chemotherapy for stage I, stage II, or stage IIIA breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Depression, Stage I Breast Cancer, Stage IIIA Breast Cancer
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1999to Apr 2007
- Phase
- Observational
- 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 to 80 years
- Women only
- Adult, Older adult
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Histologically proven newly diagnosed stage I, II, or resectable IIIA primary breast cancer Scheduled to receive chemotherapy No distant metastases --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No concurrent neoadjuvant chemotherapy Endocrine therapy: No concurrent thyroid medication Radiotherapy: No concurrent radiotherapy Surgery: See Disease Characteristics No prior oophorectomy Other: No concurrent alternative medicines alone No concurrent participation in dietary and/or exercise weight loss programs --Patient Characteristics-- Age: 18 to 80 Sex: Female Menopausal status: Premenopausal or postmenopausal Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No physical or mental disability that would preclude completing questionnaires No prior or concurrent diabetes mellitus No prior hypothyroidism or hyperthyroidism
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Prevention Studies Branch
Bethesda, Maryland, 20892
About this study
Official title: Prospective Study of Potential Factors Affecting Weight in Breast Cancer Patients Receiving Adjuvant Chemotherapy
RATIONALE: Chemotherapy may affect various factors that can lead to weight gain.
PURPOSE: Clinical trial to evaluate factors that may affect weight gain in women receiving adjuvant chemotherapy for stage I, stage II, or stage IIIA breast cancer.
Read the detailed description
OBJECTIVES: I. Evaluate the relative contributions of factors that may lead to weight gain in breast cancer patients receiving adjuvant chemotherapy. Factors examined include: Hormonal and growth factor status (follicle stimulating hormone, total, bound, and free estradiol, androgens, sex hormone binding globulin, thyroid hormones, prolactin, insulin-like growth factors I and II, and plasma leptin) Factors affecting energy intake or expenditure (oral intake, physical activity, and resting metabolic rate) Psychological factors (depression and quality of life) II. Evaluate the effect of chemotherapy on hormonal and growth factor status in these patients.
III. Assess the impact of chemotherapy on bone marrow density in these patients.
PROTOCOL OUTLINE:
Data is collected from women diagnosed with primary breast cancer at 3 points (5 visits): (i) after breast cancer surgery, but before chemotherapy begins (2 visits to NIH day hospital 1 week apart); (ii) 2-3 weeks after chemotherapy has ended (2 visits, 1 week apart); and (iii) 6 months after chemotherapy has ended (1 visit). Tests conducted during these visits include evaluation of blood for hormones, growth factors, and leptin; body composition by DXA; visceral and subcutaneous abdominal adipose tissue by an axial CT scan; and evaluation of resting metabolic rate and daily energy expenditure by a single administration of doubly labeled water at visits "a" and "b" during data collection timepoints 1 and 2. Questionnaires assessing epidemiologic risk factors for breast cancer, dietary intake, physical activity, depression, and quality of life are also administered at the three timepoints.
PROJECTED ACCRUAL:
A total of 140 patients will be accrued for this study within 1-2 years.
- Conditions
- Depression, Stage I Breast Cancer, Stage IIIA Breast Cancer, Nutrition, Stage II Breast Cancer, Psychosocial Effects/Treatment
- Keywords
- adult solid tumor, body system/site cancer, breast cancer, cancer, cancer-related problem/condition, depression, depression and suicide, nutrition, psychosocial effects/treatment, quality of life, solid tumor, stage I breast cancer, stage I, II, and IIIA breast cancer, stage II breast cancer, stage III breast cancer, stage IIIA breast cancer, stage IIIB, IV, recurrent, and metastatic breast cancer, stage, breast cancer
- Medical subject headings
- Depression, Breast Neoplasms, Neoplasms, Suicide, Recurrence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2007 (estimated)
- Study startAug 1999
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Investigators
- Noreen Aziz, Study chair, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00019643
- Sponsor's protocol ID
- 990026
- Other IDs
- 99-C-0026, NCI-99-C-0020, CDR0000066928
- Status last verified
- Mar 2012
- First submitted
- 2 Mar 2007
- Last updated
- 31 Oct 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Potential Factors Affecting Weight in Breast Cancer Patients Receiving Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT00019643
- Acronym / sponsor ID
- 990026
- Conditions
- Depression, Stage I Breast Cancer, Stage IIIA Breast Cancer, Nutrition, Stage II Breast Cancer, Psychosocial Effects/Treatment
- Keywords
- adult solid tumor, body system/site cancer, breast cancer, cancer, cancer-related problem/condition, depression, depression and suicide, nutrition
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 26 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- Aug 1999
- Study completion
- Apr 2007 (actual)
- First posted
- 6 Mar 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: Chemotherapy may affect various factors that can lead to weight gain.
PURPOSE: Clinical trial to evaluate factors that may affect weight gain in women receiving adjuvant chemotherapy for stage I, stage II, or stage IIIA breast cancer.
Detailed description
OBJECTIVES: I. Evaluate the relative contributions of factors that may lead to weight gain in breast cancer patients receiving adjuvant chemotherapy. Factors examined include: Hormonal and growth factor status (follicle stimulating hormone, total, bound, and free estradiol, androgens, sex hormone binding globulin, thyroid hormones, prolactin, insulin-like growth factors I and II, and plasma leptin) Factors affecting energy intake or expenditure (oral intake, physical activity, and resting metabolic rate) Psychological factors (depression and quality of life) II. Evaluate the effect of chemotherapy on hormonal and growth factor status in these patients.
III. Assess the impact of chemotherapy on bone marrow density in these patients.
PROTOCOL OUTLINE:
Data is collected from women diagnosed with primary breast cancer at 3 points (5 visits): (i) after breast cancer surgery, but before chemotherapy begins (2 visits to NIH day hospital 1 week apart); (ii) 2-3 weeks after chemotherapy has ended (2 visits, 1 week apart); and (iii) 6 months after chemotherapy has ended (1 visit). Tests conducted during these visits include evaluation of blood for hormones, growth factors, and leptin; body composition by DXA; visceral and subcutaneous abdominal adipose tissue by an axial CT scan; and evaluation of resting metabolic rate and daily energy expenditure by a single administration of doubly labeled water at visits "a" and "b" during data collection timepoints 1 and 2. Questionnaires assessing epidemiologic risk factors for breast cancer, dietary intake, physical activity, depression, and quality of life are also administered at the three timepoints.
PROJECTED ACCRUAL:
A total of 140 patients will be accrued for this study within 1-2 years.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Age groups
- 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.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
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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.
Noreen Aziz study chair
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Stage I Breast Cancer, run by National Institutes of Health Clinical Center (CC) 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?
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: stopped early, as of the sponsor's last update on 31 Oct 2023. 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?
The study was stopped early. 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.
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 31 Oct 2023.