Breast NeoplasmsNCT03314688
Lifestyle, Exercise, and Nutrition Study Early After Diagnosis
A study testing Dietary/Physical Activity intervention in people with Breast Neoplasms, run by Yale University at 2 sites in United States.
Trial summary
The proposed study is a randomized trial evaluating the impact of a dietary and physical activity guidelines intervention vs. usual care on adherence to breast cancer treatments, body composition, and changes in biomarkers in 172 women newly diagnosed with breast cancer scheduled to receive neoadjuvant or adjuvant… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Dietary/Physical Activity intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Jan 2018to 20 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Diagnosed with Stage I-III breast cancer
- Scheduled to receive neoadjuvant or adjuvant chemotherapy
- Physically able to walk
- Able to complete forms, understand instructions and read intervention book in English
- Agrees to be randomly assigned to either intervention or usual care group
Who cannot join
- Women who have completed their 2nd chemotherapy
- Women already practicing dietary or physical activity guidelines
- Are pregnant or intending to become pregnant in the next year
- Recent (past year) stroke/myocardial infarction or congestive heart failure/ejection fraction < 40%
- Presence of dementia or major psychiatric disease
- Non-English speaking
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dana Farber Cancer Center
Boston, Massachusetts, 02215
Yale University
New Haven, Connecticut, 06510
About this study
Official title: Lifestyle, Exercise, and Nutrition Study Early After Diagnosis (LEANer)
The proposed study is a randomized trial evaluating the impact of a dietary and physical activity guidelines intervention vs. usual care on adherence to breast cancer treatments, body composition, and changes in biomarkers in 172 women newly diagnosed with breast cancer scheduled to receive neoadjuvant or adjuvant chemotherapy.
Read the detailed description
Currently the Department of Health and Human Services, the American Cancer Society and others provide diet and exercise guidelines for cancer survivors. Many women with breast cancer do not follow these guidelines, and also elect to delay concerted efforts toward following them until active treatment is complete. However, adoption of these recommended lifestyle behaviors soon after diagnosis may prevent adverse changes in body composition and breast cancer biomarkers and may even improve the efficacy of treatment resulting in improved breast cancer prognosis. Further, by increasing our understanding of the mechanisms mediating the association between lifestyle behaviors and breast cancer survival, this study will improve our knowledge of how changes in diet and physical activity influence breast cancer outcomes. Lastly, guidelines for breast cancer survivors also overlap with those for diabetes and cardiovascular disease (CVD) prevention, the latter being a common cause of breast cancer mortality.
The proposed study will examine, in 172 women newly diagnosed with Stage I-III breast cancer who are not practicing the dietary and lifestyle guidelines, and who are scheduled to receive neoadjuvant or adjuvant chemotherapy, the effect of a 1-year dietary and physical activity guidelines intervention vs. usual care on the following breast cancer outcomes measured before beginning chemotherapy (Time 0), post chemotherapy (Time 1), at one-year post-diagnosis (Time 2), at two years post-diagnosis (Time 3), and at five-years post-diagnosis (Time 4): adherence to treatment, and changes in biomarkers, body composition, diet, physical activity and quality of life.
- Conditions
- Breast Neoplasms
- Being tested
- Dietary/Physical Activity intervention, Usual Care
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary/Physical Activity interventionBehavioural
Motivational counseling to follow established dietary and exercise guidelines.
Usual CareBehavioural
Standard follow-up care and educational materials. Lifestyle counseling offered at the conclusion of the trial.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Group | Active comparator | Standardized breast cancer follow up care and materials regarding treatment (i.e., chemotherapy and endocrine therapy when relevant).
Lifestyle intervention books for breast cancer survivors at the end of the study. Women will also be offered a counselling session with a registered study dietician at the end of the study. Receives: Behavioral: Usual Care |
| Dietary/Physical Activity Intervention | Experimental | Eleven 30-min counseling sessions over six months (weekly, then biweekly, then monthly) with additional sessions in the latter 6 months (5 additional monthly sessions for a total of 16 sessions), timed with their oncology visit or via telephone if not coming in for oncology visit. Sessions focus on motivating health dietary choices and physical activity (home-based program). Receives: Behavioral: Dietary/Physical Activity intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Treatment Measured by Chemotherapy Completion Rate
Chemotherapy completion rate will be assessed (via medical records) as the average relative dose-intensity (RDI) for the originally planned regimen based on standard formulas. RDI is calculated by dividing the participant's actual dose by the planned dose to get a percentage of actual dose/planned dose.
Measured: before initiating chemotherapy to post-chemotherapy, up to 7 months
Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs)
This outcome was updated when results were entered. COVID restrictions prevented the intended method of assessment using urine collection. In its place are the responses on 3 questions regarding adherence.
- In the past month, how often did you take your aromatase inhibitor (AI)/tamoxifen pills as the doctor prescribed? ('All the time' responses counted)
- In the past month, how often did you forget to take one or more of your aromatase inhibitor (AI)/tamoxifen pills? ('Never' responses counted)
- In the past month, how often did you decide to skip one or more of your aromatase inhibitor (AI)/tamoxifen pills? ('Never' responses counted)
Measured: 12 months after enrollment
Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs).
This outcome was updated when results were entered. COVID restrictions prevented the intended method of assessment using urine collection. In its place are the responses on 3 questions regarding adherence.
In the past month, how often did you take your aromatase inhibitor (AI)/tamoxifen pills as the doctor prescribed? ('All the time' responses counted- Q1) In the past month, how often did you forget to take one or more of your aromatase inhibitor (AI)/tamoxifen pills? ('Never' responses counted- Q2) In the past month, how often did you decide to skip one or more of your aromatase inhibitor (AI)/tamoxifen pills? ('Never' responses counted- Q3)
Measured: 24 months after enrollment
Secondary outcomes (11)
Pathological Complete Response
In the subset of patients receiving neoadjuvant chemotherapy, no evidence of viable invasive tumor cells at the primary tumor site and axillary lymph nodes in the surgical specimen. Data presented here is the number of participants with a pathological Complete Response.
Measured: At the time of surgical resection following initial course of chemotherapy
Mean Insulin Level
Assessed by fasting blood (fast of 12 hours or more).
Measured: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year
Mean C-reactive Protein Level
Assessed by fasting blood (fast of 12 hours or more).
Measured: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year
Mean Body Composition-body Weight
Assessed by measured weight
Measured: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years
Mean Body Composition-body Mass Index (BMI)
Assessed from measured weight and measured height
Measured: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years
Mean Body Composition-body Fat
Assessed by dual energy X-ray absorptiometry (DEXA)
Measured: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years
Body Composition-lean Body Mass
Assessed by dual energy X-ray absorptiometry (DEXA)
Measured: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years
Body Composition-bone Mineral Density
Assessed by dual energy X-ray absorptiometry (DEXA), -1.0 or higher are normal; -1.1 to -2.4 indicate low bone mass (osteopenia), and -2.5 or lower indicate osteoporosis.
Measured: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years
Mean Score Quality of Life (QoL) Patient-Reported Outcomes Measurement Information System (PROMIS) Global Physical Health (GPH)
PROMIS Global Physical Health (GPH) score is a measure of physical well-being. It uses a T-score metric standardized to a U.S. general population mean of 50 and a standard deviation of 10. Higher scores indicate better physical health, with scores typically ranging from 20 to 80.
Measured: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years
Mean Score Quality of Life (QoL) Patient-Reported Outcomes Measurement Information System (PROMIS) Global Mental Health (GMH)
PROMIS Global Mental Health (GMH) score is a measure of mental well-being. It uses a T-score metric standardized to a U.S. general population mean of 50 and a standard deviation of 10. Higher scores indicate better physical health, with scores typically ranging from 20 to 80.
Measured: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years
Fecal Microbiome
Number of participants that were able to provide a sample.
Measured: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start2 Jan 2018
- Primary completion24 Mar 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Melinda Irwin, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314688
- Sponsor's protocol ID
- 2000020335
- Other IDs
- 1R01CA207753-01A1
- Status last verified
- Jun 2026
- First submitted
- 13 Sep 2017
- Last updated
- 17 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Puklin LS, Li FY, Ferrucci LM, Cartmel B, Harrigan M, McGowan C, Zupa M, Ligibel JA, Sanft T, Irwin ML. Effect of a lifestyle intervention during chemotherapy for breast cancer on quality of life. JNCI Cancer Spectr. 2026 Jan 9;10(1):pkaf125. doi: 10.1093/jncics/pkaf125.
PubMed 41452765Sanft T, Harrigan M, McGowan C, Cartmel B, Zupa M, Li FY, Ferrucci LM, Puklin L, Cao A, Nguyen TH, Neuhouser ML, Hershman DL, Basen-Engquist K, Jones BA, Knobf T, Chagpar AB, Silber A, Tanasijevic A, Ligibel JA, Irwin ML. Randomized Trial of Exercise and Nutrition on Chemotherapy Completion and Pathologic Complete Response in Women With Breast Cancer: The Lifestyle, Exercise, and Nutrition Early After Diagnosis Study. J Clin Oncol. 2023 Dec 1;41(34):5285-5295. doi: 10.1200/JCO.23.00871. Epub 2023 Sep 1.
PubMed 37656930Sanft T, Harrigan M, Cartmel B, Ferrucci LM, Li FY, McGowan C, Zupa M, Nguyen TH, Ligibel J, Neuhouser ML, Hershman DL, Basen-Engquist K, Jones B, Knobf T, Chagpar A, Silber A, Irwin ML. Effect of healthy diet and exercise on chemotherapy completion rate in women with breast cancer: The Lifestyle, Exercise and Nutrition Early after Diagnosis (LEANer) study: Study protocol for a randomized clinical trial. Contemp Clin Trials. 2021 Oct;109:106508. doi: 10.1016/j.cct.2021.106508. Epub 2021 Jul 16.
PubMed 34274495
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle, Exercise, and Nutrition Study Early After Diagnosis (LEANer)
- ClinicalTrials.gov ID
- NCT03314688
- Acronym / sponsor ID
- 2000020335
- Conditions
- Breast Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 24 Mar 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 19 Oct 2017 (actual)
- Results
- Posted 14 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study is a randomized trial evaluating the impact of a dietary and physical activity guidelines intervention vs. usual care on adherence to breast cancer treatments, body composition, and changes in biomarkers in 172 women newly diagnosed with breast cancer scheduled to receive neoadjuvant or adjuvant chemotherapy.
Detailed description
Currently the Department of Health and Human Services, the American Cancer Society and others provide diet and exercise guidelines for cancer survivors. Many women with breast cancer do not follow these guidelines, and also elect to delay concerted efforts toward following them until active treatment is complete. However, adoption of these recommended lifestyle behaviors soon after diagnosis may prevent adverse changes in body composition and breast cancer biomarkers and may even improve the efficacy of treatment resulting in improved breast cancer prognosis. Further, by increasing our understanding of the mechanisms mediating the association between lifestyle behaviors and breast cancer survival, this study will improve our knowledge of how changes in diet and physical activity influence breast cancer outcomes. Lastly, guidelines for breast cancer survivors also overlap with those for diabetes and cardiovascular disease (CVD) prevention, the latter being a common cause of breast cancer mortality.
The proposed study will examine, in 172 women newly diagnosed with Stage I-III breast cancer who are not practicing the dietary and lifestyle guidelines, and who are scheduled to receive neoadjuvant or adjuvant chemotherapy, the effect of a 1-year dietary and physical activity guidelines intervention vs. usual care on the following breast cancer outcomes measured before beginning chemotherapy (Time 0), post chemotherapy (Time 1), at one-year post-diagnosis (Time 2), at two years post-diagnosis (Time 3), and at five-years post-diagnosis (Time 4): adherence to treatment, and changes in biomarkers, body composition, diet, physical activity and quality of life.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care Group | Active comparator | Behavioral: Usual CareStandardized breast cancer follow up care and materials regarding treatment (i.e., chemotherapy and endocrine therapy when relevant). Lifestyle intervention books for breast cancer survivors at the end of the study. Women will also be offered a counselling session with a registered study dietician at the end of the study. |
| Dietary/Physical Activity Intervention | Experimental | Behavioral: Dietary/Physical Activity interventionEleven 30-min counseling sessions over six months (weekly, then biweekly, then monthly) with additional sessions in the latter 6 months (5 additional monthly sessions for a total of 16 sessions), timed with their oncology visit or via telephone if not coming in for oncology visit. Sessions focus on motivating health dietary choices and physical activity (home-based program). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with Stage I-III breast cancer
- Scheduled to receive neoadjuvant or adjuvant chemotherapy
- Physically able to walk
- Able to complete forms, understand instructions and read intervention book in English
- Agrees to be randomly assigned to either intervention or usual care group
Key exclusion criteria (6 listed)
- Women who have completed their 2nd chemotherapy
- Women already practicing dietary or physical activity guidelines
- Are pregnant or intending to become pregnant in the next year
- Recent (past year) stroke/myocardial infarction or congestive heart failure/ejection fraction < 40%
- Presence of dementia or major psychiatric disease
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/Physical Activity interventionMotivational counseling to follow established dietary and exercise guidelines. | Behavioural | Dietary/Physical Activity Intervention |
| Usual CareStandard follow-up care and educational materials. Lifestyle counseling offered at the conclusion of the trial. | Behavioural | Usual Care Group |
Primary outcome
Adherence to Treatment Measured by Chemotherapy Completion Rate
Time frame: before initiating chemotherapy to post-chemotherapy, up to 7 months
Chemotherapy completion rate will be assessed (via medical records) as the average relative dose-intensity (RDI) for the originally planned regimen based on standard formulas. RDI is calculated by dividing the participant's actual dose by the planned dose to get a percentage of actual dose/planned dose.
Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs)
Time frame: 12 months after enrollment
This outcome was updated when results were entered. COVID restrictions prevented the intended method of assessment using urine collection. In its place are the responses on 3 questions regarding adherence. 1. In the past month, how often did you take your aromatase inhibitor (AI)/tamoxifen pills as the doctor prescribed? ('All the time' responses counted) 2. In the past month, how often did you forget to take one or more of your aromatase inhibitor (AI)/tamoxifen pills? ('Never' responses counted) 3. In the past month, how often did you decide to skip one or more of your aromatase inhibitor (AI)/tamoxifen pills? ('Never' responses counted)
Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs).
Time frame: 24 months after enrollment
This outcome was updated when results were entered. COVID restrictions prevented the intended method of assessment using urine collection. In its place are the responses on 3 questions regarding adherence. In the past month, how often did you take your aromatase inhibitor (AI)/tamoxifen pills as the doctor prescribed? ('All the time' responses counted- Q1) In the past month, how often did you forget to take one or more of your aromatase inhibitor (AI)/tamoxifen pills? ('Never' responses counted- Q2) In the past month, how often did you decide to skip one or more of your aromatase inhibitor (AI)/tamoxifen pills? ('Never' responses counted- Q3)
11 secondary outcomes
Pathological Complete Response
Time frame: At the time of surgical resection following initial course of chemotherapy
Mean Insulin Level
Time frame: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year
Mean C-reactive Protein Level
Time frame: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year
Mean Body Composition-body Weight
Time frame: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years
Mean Body Composition-body Mass Index (BMI)
Time frame: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years
Mean Body Composition-body Fat
Time frame: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years
Body Composition-lean Body Mass
Time frame: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years
Body Composition-bone Mineral Density
Time frame: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years
Mean Score Quality of Life (QoL) Patient-Reported Outcomes Measurement Information System (PROMIS) Global Physical Health (GPH)
Time frame: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years
Mean Score Quality of Life (QoL) Patient-Reported Outcomes Measurement Information System (PROMIS) Global Mental Health (GMH)
Time frame: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years
Fecal Microbiome
Time frame: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41452765Puklin LS, Li FY, Ferrucci LM, Cartmel B, Harrigan M, McGowan C, Zupa M, Ligibel JA, Sanft T, Irwin ML. Effect of a lifestyle intervention during chemotherapy for breast cancer on quality of life. JNCI Cancer Spectr. 2026 Jan 9;10(1):pkaf125. doi: 10.1093/jncics/pkaf125.
- Derived from this study: PubMed 37656930Sanft T, Harrigan M, McGowan C, Cartmel B, Zupa M, Li FY, Ferrucci LM, Puklin L, Cao A, Nguyen TH, Neuhouser ML, Hershman DL, Basen-Engquist K, Jones BA, Knobf T, Chagpar AB, Silber A, Tanasijevic A, Ligibel JA, Irwin ML. Randomized Trial of Exercise and Nutrition on Chemotherapy Completion and Pathologic Complete Response in Women With Breast Cancer: The Lifestyle, Exercise, and Nutrition Early After Diagnosis Study. J Clin Oncol. 2023 Dec 1;41(34):5285-5295. doi: 10.1200/JCO.23.00871. Epub 2023 Sep 1.
- Derived from this study: PubMed 34274495Sanft T, Harrigan M, Cartmel B, Ferrucci LM, Li FY, McGowan C, Zupa M, Nguyen TH, Ligibel J, Neuhouser ML, Hershman DL, Basen-Engquist K, Jones B, Knobf T, Chagpar A, Silber A, Irwin ML. Effect of healthy diet and exercise on chemotherapy completion rate in women with breast cancer: The Lifestyle, Exercise and Nutrition Early after Diagnosis (LEANer) study: Study protocol for a randomized clinical trial. Contemp Clin Trials. 2021 Oct;109:106508. doi: 10.1016/j.cct.2021.106508. Epub 2021 Jul 16.
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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.
Melinda Irwin, Ph.D. principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary/Physical Activity intervention in people with Breast Neoplasms, run by Yale University at 2 sites 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 5 inclusion and 6 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 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 14 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adherence to Treatment Measured by Chemotherapy Completion Rate (time frame: before initiating chemotherapy to post-chemotherapy, up to 7 months). 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?
On the ClinicalTrials.gov record for NCT03314688, which also lists 3 linked publications.
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 17 Jul 2026.