Anatomic Stage I Breast Cancer AJCC v8NCT03953157
Dietary and Exercise Interventions in Reducing Side Effects in Patients With Stage I-IIIa Breast Cancer Receiving Aromatase Inhibitors
A study testing Dietary Intervention, Exercise Intervention and Questionnaire Administration in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
This phase I/II trial studies how well dietary and exercise interventions work in reducing side effects in patients with stage I-IIIa breast cancer taking aromatase inhibitors. Anti-inflammatory Mediterranean dietary and bone strengthening exercise interventions may alleviate medication side effects such as joint and… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8
- What is being tested?
- Dietary Intervention, Exercise Intervention and Questionnaire Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2019to 19 Dec 2024
- 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
Who may be able to join
- At least 6 months since breast cancer diagnosis up to 2 years since diagnosis.
- Diagnosed with localized breast cancer, up to stage IIIa.
- Has been taking aromatase inhibitor (AIs) for at least six months.
- Has been experiencing mild to moderate arthralgia (joint pain) for at least 2 months determined by the Brief Pain Inventory (BPI).
- At least 6 months post chemotherapy or radiation treatment.
- Subjects must be in good health as determined by medical history, physical examination, iDXA scan and clinical laboratory measurements.
- Postmenopausal either natural or surgical or postmenopausal caused by ovarian suppression treatments administered to premenopausal women.
- Currently taking aromatase inhibitor medication.
Who cannot join
- Diagnosed with metastatic breast cancer.
- Currently undergoing chemotherapy or radiation treatment.
- Food allergies of any kind, or any medical condition requiring mandatory dietary restrictions.
- A bone mineral density (BMD) T score less than -1, or fracture since taking AIs, or current use of glucocorticoids.
- Taking bisphosphonates or any other medication for bone loss.
- Significant cardiac, pulmonary, renal, liver or psychiatric disease.
Show all 9Show fewer
- Currently undergoing or engaging in a regular exercise program.
- Muscular, orthopedic, or cardiovascular limitations that would prevent full participation in exercise.
- Body mass index (BMI) greater than 40 kg/m^2.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: Improving Health of Women on Aromatase Inhibitors
This phase I/II trial studies how well dietary and exercise interventions work in reducing side effects in patients with stage I-IIIa breast cancer taking aromatase inhibitors. Anti-inflammatory Mediterranean dietary and bone strengthening exercise interventions may alleviate medication side effects such as joint and bone pain and protectively influence bone mineral density, improve heart functioning, and reduce risk of breast cancer recurrence in breast cancer patients taking aromatase inhibitors.
Read the detailed description
PRIMARY OBJECTIVES:
- To recruit an ethnically, racially and culturally diverse sample of postmenopausal women diagnosed with estrogen receptor positive breast cancer who are currently taking aromatase inhibitor (AI), establish eligibility, and randomly allocate 20 participants to a two-arm parallel intervention trial.
II. Conduct baseline measurements of: body composition and bone mineral density, reported muscle and joint pain; inflammatory, cardiovascular and bone health markers contained in blood serum; and, cardiovascular function.
III. Conduct a three month anti-inflammatory dietary intervention in one arm, and bone strengthening exercise intervention in the other study arm.
IV. At completion of these 3-month interventions, evaluate changes since baseline of body composition, bone density, reported muscle and joint pain, and inflammatory and cardiovascular measurements within each intervention arm, and preliminarily contrast changes between intervention arms.
- Utilize results from both intervention arms to design a larger 2x2 randomized factorial trial designed to assess effects of anti-inflammatory diet, effects of bone promoting exercise, and combined diet and exercise intervention effects on joint and muscle pain, inflammatory markers, bone mineral density, and cardiovascular measures.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive a controlled anti-inflammatory diet over 12 weeks.
ARM II: Patients undergo controlled exercise sessions with a dedicated trainer 3 times a week for up to 1 hour each over 12 weeks.
After completion of study, patients are followed up at 1 week.
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8
- Being tested
- Dietary Intervention, Exercise Intervention, Questionnaire Administration
- Medical subject headings
- Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary InterventionDietary supplement
Also called Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions
Receive dietary intervention
Exercise InterventionBehavioural
Receive exercise intervention
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (dietary intervention) | Experimental | Patients receive a controlled anti-inflammatory diet over 12 weeks. Receives: Dietary Supplement: Dietary Intervention; Other: Questionnaire Administration |
| Arm II (exercise intervention) | Experimental | Patients undergo controlled exercise sessions with a dedicated trainer 3 times a week for up to 1 hour each over 12 weeks. Receives: Behavioral: Exercise Intervention; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density
Will be scanned by dual x-ray absorptiometry (iDXA).
Measured: Baseline up to 1 week post intervention
Joint and muscle pain
Joint and muscle pain will be measured by the Brief Pain Inventory, a frequently administered assessment for studies of women on aromatase inhibitors (AIs). Participants will be asked about use of pain medication and supplements such as chondroitin and glucosamine. Subjects will also fill out standard visual analog scales to rate intensity of pain ranging from 1 to 10, as well as locate source of pain on standardized human figures available from International Society of Anesthetic Pharmacology. Additionally grip strength, a common marker of functional muscle and joint weakness, will be assessed using a dynamometer.
Measured: Baseline up to 1 week post intervention
Inflammatory markers
Fasting blood samples will be collected at baseline and end of intervention. Serum markers, IL-6, Il-8, TNF-?, MCP-1, hs-CRP, leptin, TGFbeta, IL-1beta, and CRP will be quantified.
Measured: Baseline up to 1 week post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start7 Oct 2019
- Primary completion19 Dec 2024
- Study completion19 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine L Carpenter, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953157
- Sponsor's protocol ID
- 18-001926
- Other IDs
- NCI-2019-02909
- Status last verified
- Dec 2024
- First submitted
- 15 May 2019
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Health of Women on Aromatase Inhibitors
- ClinicalTrials.gov ID
- NCT03953157
- Acronym / sponsor ID
- 18-001926
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 19 Dec 2024 (actual)
- Study completion
- 19 Dec 2024 (actual)
- First posted
- 16 May 2019 (actual)
- 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.
This phase I/II trial studies how well dietary and exercise interventions work in reducing side effects in patients with stage I-IIIa breast cancer taking aromatase inhibitors. Anti-inflammatory Mediterranean dietary and bone strengthening exercise interventions may alleviate medication side effects such as joint and bone pain and protectively influence bone mineral density, improve heart functioning, and reduce risk of breast cancer recurrence in breast cancer patients taking aromatase inhibitors.
Detailed description
PRIMARY OBJECTIVES:
- To recruit an ethnically, racially and culturally diverse sample of postmenopausal women diagnosed with estrogen receptor positive breast cancer who are currently taking aromatase inhibitor (AI), establish eligibility, and randomly allocate 20 participants to a two-arm parallel intervention trial.
II. Conduct baseline measurements of: body composition and bone mineral density, reported muscle and joint pain; inflammatory, cardiovascular and bone health markers contained in blood serum; and, cardiovascular function.
III. Conduct a three month anti-inflammatory dietary intervention in one arm, and bone strengthening exercise intervention in the other study arm.
IV. At completion of these 3-month interventions, evaluate changes since baseline of body composition, bone density, reported muscle and joint pain, and inflammatory and cardiovascular measurements within each intervention arm, and preliminarily contrast changes between intervention arms.
- Utilize results from both intervention arms to design a larger 2x2 randomized factorial trial designed to assess effects of anti-inflammatory diet, effects of bone promoting exercise, and combined diet and exercise intervention effects on joint and muscle pain, inflammatory markers, bone mineral density, and cardiovascular measures.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive a controlled anti-inflammatory diet over 12 weeks.
ARM II: Patients undergo controlled exercise sessions with a dedicated trainer 3 times a week for up to 1 hour each over 12 weeks.
After completion of study, patients are followed up at 1 week.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (dietary intervention) | Experimental | Dietary Supplement: Dietary Intervention, Other: Questionnaire AdministrationPatients receive a controlled anti-inflammatory diet over 12 weeks. |
| Arm II (exercise intervention) | Experimental | Behavioral: Exercise Intervention, Other: Questionnaire AdministrationPatients undergo controlled exercise sessions with a dedicated trainer 3 times a week for up to 1 hour each over 12 weeks. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- At least 6 months since breast cancer diagnosis up to 2 years since diagnosis.
- Diagnosed with localized breast cancer, up to stage IIIa.
- Has been taking aromatase inhibitor (AIs) for at least six months.
- Has been experiencing mild to moderate arthralgia (joint pain) for at least 2 months determined by the Brief Pain Inventory (BPI).
- At least 6 months post chemotherapy or radiation treatment.
Key exclusion criteria (9 listed)
- Diagnosed with metastatic breast cancer.
- Currently undergoing chemotherapy or radiation treatment.
- Food allergies of any kind, or any medical condition requiring mandatory dietary restrictions.
- A bone mineral density (BMD) T score less than -1, or fracture since taking AIs, or current use of glucocorticoids.
- Taking bisphosphonates or any other medication for bone loss.
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 |
|---|---|---|
| Dietary InterventionAlso: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition InterventionsReceive dietary intervention | Dietary supplement | Arm I (dietary intervention) |
| Exercise InterventionReceive exercise intervention | Behavioural | Arm II (exercise intervention) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (dietary intervention), Arm II (exercise intervention) |
Primary outcome
Bone mineral density
Time frame: Baseline up to 1 week post intervention
Will be scanned by dual x-ray absorptiometry (iDXA).
Joint and muscle pain
Time frame: Baseline up to 1 week post intervention
Joint and muscle pain will be measured by the Brief Pain Inventory, a frequently administered assessment for studies of women on aromatase inhibitors (AIs). Participants will be asked about use of pain medication and supplements such as chondroitin and glucosamine. Subjects will also fill out standard visual analog scales to rate intensity of pain ranging from 1 to 10, as well as locate source of pain on standardized human figures available from International Society of Anesthetic Pharmacology. Additionally grip strength, a common marker of functional muscle and joint weakness, will be assessed using a dynamometer.
Inflammatory markers
Time frame: Baseline up to 1 week post intervention
Fasting blood samples will be collected at baseline and end of intervention. Serum markers, IL-6, Il-8, TNF-?, MCP-1, hs-CRP, leptin, TGFbeta, IL-1beta, and CRP will be quantified.
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 18 Jun 2025.
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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.
Catherine L Carpenter principal investigator
UCLA / Jonsson Comprehensive 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 Dietary Intervention, Exercise Intervention and Questionnaire Administration in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by Jonsson Comprehensive 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 9 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 18 Jun 2025. 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 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?
Bone mineral density (time frame: Baseline up to 1 week post intervention). 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 18 Jun 2025.