Breast CarcinomaNCT02983279
Caloric Restriction Before Surgery in Treating Patients With Endometrial, Prostate, or Breast Cancer
A study testing Dietary Intervention, Counseling and Therapeutic in people with Breast Carcinoma and Endometrial Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial summary
The purpose of this trial is to determine that sort term calorie restriction will affect tumor biology in biopsy proven breast, endometrial or prostate cancers, which will positively impact biomarkers including miR-21, an onco-miR known to impact cancer outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Carcinoma, Endometrial Carcinoma, Prostate Carcinosarcoma
- What is being tested?
- Dietary Intervention, Counseling and Therapeutic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2016to 29 Dec 2022
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological documentation of cancer of the endometrium, prostate or breast.
- Candidate for definitive cancer surgery as determined by treating physician
- The ability for the definitive cancer surgery to be scheduled within 4-12 weeks post initiation of dietary intervention as determined by the enrolling physician (not from diagnosis - but from start of diet).
- No other malignancy within the past 6 months unless it was a non-melanomatous skin lesion
- BMI ≥21
- ECOG Performance Status of 2 or less
- Patient must not be on anti-retrovirals since they may alter patient metabolism
Who cannot join
- Patient is not a candidate for definitive cancer surgery
- Definitive cancer surgery can not be performed within 4-12 weeks post study enrollment as determined by the enrolling physician.
- Body Mass Index < 21
- Another malignancy within the past 6 months that was not a non-melanomatous skin lesion
- ECOG Performance Status >2
- Patient on anti-retrovirals since they may alter patient metabolism
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Caloric Restriction for Oncology Research: Pre-operative Caloric Restriction Prior to Definitive Oncologic Surgery
The purpose of this trial is to determine that sort term calorie restriction will affect tumor biology in biopsy proven breast, endometrial or prostate cancers, which will positively impact biomarkers including miR-21, an onco-miR known to impact cancer outcomes.
Read the detailed description
PRIMARY OBJECTIVES:
- Investigate if caloric restriction will change serum micro ribonucleic acid (RNA) 21 (miR-21) expression in patients with prostate, endometrial or breast cancer.
SECONDARY OBJECTIVES:
- Investigate measurable changes induced by caloric restriction on both patient (host) and tumor characteristics from caloric restriction.
- Investigate the adherence of the patient to the diet.
- Weight, height, and body composition will be assessed via BodyMetrix. BodyMetrix uses ultrasound technology to measure subcutaneous fat.
- Patients will have psycho-social evaluation using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) test (prostate cancer), FACT-Breast (B) test (breast cancer), or the FACT-Endometrial Cancer (En) test (endometrial cancer) and the Patient Reported Outcomes Measurement Information System (PROMIS) cancer fatigue short form at baseline, midway through diet, and at the conclusion of the diet.
- Patient's nutritional status (Mini Nutritional Assessment [MNA] form) will be assessed, and their caloric needs will be calculated.
- Local recurrence, progression free survival, distant metastases and overall survival will be assessed.
- Being tested
- Dietary Intervention, Counseling, Therapeutic
- Medical subject headings
- Breast Neoplasms, Endometrial Neoplasms
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, Nutrition Intervention
Undergo caloric restriction diet
CounselingOther
Also called Counseling Intervention
Undergo counselor-led dietary counseling
TherapeuticProcedure or surgery
Undergo standard of care surgery
| Study group | Role | What they receive |
|---|---|---|
| Dietary counseling, caloric restriction diet | Experimental | Patients then undergo 25% caloric intake for 3-12 weeks prior to definitive cancer surgery. Receives: Dietary Supplement: Dietary Intervention; Other: Counseling; Procedure: Therapeutic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in miR-21 expression assessed in serum
Will be evaluated by a two-sided paired t-test at significance level 0.05.
Measured: Baseline up to 12 weeks
Secondary outcomes (21)
Overall adherence with diet intervention defined as 90% of all logged events meeting the diet restriction target
Measured: Up to 12 weeks
Change in body composition, assessed via BodyMetrix
Will be analyzed via a paired t-test.
Measured: Baseline up to 12 weeks
Change in prostate tumor gene expression
Measured: Baseline up to 12 weeks
Change in weight, defined as a percent change
Will be assessed by modeling BMI as a function of time via mixed-effects regression.
Measured: Baseline up to 12 weeks
Change in temperature
Will be assessed as a function of time via mixed-effects regression.
Measured: Baseline up to 12 weeks
Change in genomic expression of microRNA 21 (miR-21)
Initial cancer biopsy specimen for genomic analysis will be comped to definitive surgical specimens.
Measured: Baseline to after definitive surgery
Change in insulin
Will be assessed as a function of time via mixed-effects regression.
Measured: Baseline up to 12 weeks
Change in biome analysis assessed by rectal swab
Measured: Baseline to 12 weeks
Change in psycho-social outcomes, assessed by the FACT-B
Will be assessed as a function of time via mixed-effects regression.
Measured: Baseline up to 12 weeks
Changes in nutritional status assessed by a Mini Nutritional Assessment (MNA)
Will be assessed as a function of time via mixed-effects regression.
Measured: Baseline up to 12 weeks
Local recurrence, assessed through patient records
Will be analyzed via survival methods, specifically the Kaplan-Meier method and the log-rank test. If sufficient events occur, may assess the impact of various patient and clinical/treatment variables on these outcomes via Cox proportional hazards regression. Will be assessed and compared with historic controls using the Kaplan Meier method.
Measured: From the date of study enrollment to time of event, assessed up to 12 weeks
Distant metastases, assessed through patient records
Will be analyzed via survival methods, specifically the Kaplan-Meier method and the log-rank test. If sufficient events occur, may assess the impact of various patient and clinical/treatment variables on these outcomes via Cox proportional hazards regression. Will be assessed and compared with historic controls using the Kaplan Meier method.
Measured: From the date of study enrollment to time of event, assessed up to 12 weeks
Progression free survival, assessed through patient records
Will be analyzed via survival methods, specifically the Kaplan-Meier method and the log-rank test. If sufficient events occur, may assess the impact of various patient and clinical/treatment variables on these outcomes via Cox proportional hazards regression. Will be assessed and compared with historic controls using the Kaplan Meier method.
Measured: From the date of study enrollment to time of event, assessed up to 12 weeks
Overall survival, assessed through patient records
Will be analyzed via survival methods, specifically the Kaplan-Meier method and the log-rank test. If sufficient events occur, may assess the impact of various patient and clinical/treatment variables on these outcomes via Cox proportional hazards regression. Will be assessed and compared with historic controls using the Kaplan Meier method.
Measured: From the date of study enrollment to time of event, assessed up to 12 weeks
Change in weight, defined by body mass index as weight in kg divided by height in meters squared
Will be assessed by modeling BMI as a function of time via mixed-effects regression.
Measured: Baseline up to 12 weeks
Change in blood pressure
Will be assessed as a function of time via mixed-effects regression.
Measured: Baseline up to 12 weeks
Change in heart rate
Will be assessed as a function of time via mixed-effects regression.
Measured: Baseline up to 12 weeks
Change in respiratory rate
Will be assessed as a function of time via mixed-effects regression.
Measured: Baseline up to 12 weeks
Change in psycho-social outcomes, assessed by the FACT-P
Will be assessed as a function of time via mixed-effects regression.
Measured: Baseline up to 12 weeks
Change in psycho-social outcomes, assessed by the FACT-En
Will be assessed as a function of time via mixed-effects regression.
Measured: Baseline up to 12 weeks
Change in psycho-social outcomes, assessed by the POMIS cancer fatigue short form
Will be assessed as a function of time via mixed-effects regression.
Measured: Baseline up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study start20 Sep 2016
- Primary completion27 Oct 2021
- Study completion29 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole Simone, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983279
- Sponsor's protocol ID
- 16D.501
- Other IDs
- JT 8646
- Status last verified
- Apr 2025
- First submitted
- 14 Nov 2016
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caloric Restriction for Oncology Research: Pre-operative Caloric Restriction Prior to Definitive Oncologic Surgery
- ClinicalTrials.gov ID
- NCT02983279
- Acronym / sponsor ID
- 16D.501
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 20 Sep 2016 (actual)
- Primary completion
- 27 Oct 2021 (actual)
- Study completion
- 29 Dec 2022 (actual)
- First posted
- 6 Dec 2016 (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 purpose of this trial is to determine that sort term calorie restriction will affect tumor biology in biopsy proven breast, endometrial or prostate cancers, which will positively impact biomarkers including miR-21, an onco-miR known to impact cancer outcomes.
Detailed description
PRIMARY OBJECTIVES:
- Investigate if caloric restriction will change serum micro ribonucleic acid (RNA) 21 (miR-21) expression in patients with prostate, endometrial or breast cancer.
SECONDARY OBJECTIVES:
- Investigate measurable changes induced by caloric restriction on both patient (host) and tumor characteristics from caloric restriction.
- Investigate the adherence of the patient to the diet.
- Weight, height, and body composition will be assessed via BodyMetrix. BodyMetrix uses ultrasound technology to measure subcutaneous fat.
- Patients will have psycho-social evaluation using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) test (prostate cancer), FACT-Breast (B) test (breast cancer), or the FACT-Endometrial Cancer (En) test (endometrial cancer) and the Patient Reported Outcomes Measurement Information System (PROMIS) cancer fatigue short form at baseline, midway through diet, and at the conclusion of the diet.
- Patient's nutritional status (Mini Nutritional Assessment [MNA] form) will be assessed, and their caloric needs will be calculated.
- Local recurrence, progression free survival, distant metastases and overall survival will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary counseling, caloric restriction diet | Experimental | Dietary Supplement: Dietary Intervention, Other: Counseling, Procedure: TherapeuticPatients then undergo 25% caloric intake for 3-12 weeks prior to definitive cancer surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histological documentation of cancer of the endometrium, prostate or breast.
- Candidate for definitive cancer surgery as determined by treating physician
- The ability for the definitive cancer surgery to be scheduled within 4-12 weeks post initiation of dietary intervention as determined by the enrolling physician (not from diagnosis - but from start of diet).
- No other malignancy within the past 6 months unless it was a non-melanomatous skin lesion
- BMI ≥21
Key exclusion criteria (6 listed)
- Patient is not a candidate for definitive cancer surgery
- Definitive cancer surgery can not be performed within 4-12 weeks post study enrollment as determined by the enrolling physician.
- Body Mass Index < 21
- Another malignancy within the past 6 months that was not a non-melanomatous skin lesion
- ECOG Performance Status >2
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, Nutrition InterventionUndergo caloric restriction diet | Dietary supplement | Dietary counseling, caloric restriction diet |
| CounselingAlso: Counseling InterventionUndergo counselor-led dietary counseling | Other | Dietary counseling, caloric restriction diet |
| TherapeuticUndergo standard of care surgery | Procedure or surgery | Dietary counseling, caloric restriction diet |
Primary outcome
Change in miR-21 expression assessed in serum
Time frame: Baseline up to 12 weeks
Will be evaluated by a two-sided paired t-test at significance level 0.05.
21 secondary outcomes
Overall adherence with diet intervention defined as 90% of all logged events meeting the diet restriction target
Time frame: Up to 12 weeks
Change in body composition, assessed via BodyMetrix
Time frame: Baseline up to 12 weeks
Change in prostate tumor gene expression
Time frame: Baseline up to 12 weeks
Change in weight, defined as a percent change
Time frame: Baseline up to 12 weeks
Change in temperature
Time frame: Baseline up to 12 weeks
Change in genomic expression of microRNA 21 (miR-21)
Time frame: Baseline to after definitive surgery
Change in insulin
Time frame: Baseline up to 12 weeks
Change in biome analysis assessed by rectal swab
Time frame: Baseline to 12 weeks
Change in psycho-social outcomes, assessed by the FACT-B
Time frame: Baseline up to 12 weeks
Changes in nutritional status assessed by a Mini Nutritional Assessment (MNA)
Time frame: Baseline up to 12 weeks
Local recurrence, assessed through patient records
Time frame: From the date of study enrollment to time of event, assessed up to 12 weeks
Distant metastases, assessed through patient records
Time frame: From the date of study enrollment to time of event, assessed up to 12 weeks
Progression free survival, assessed through patient records
Time frame: From the date of study enrollment to time of event, assessed up to 12 weeks
Overall survival, assessed through patient records
Time frame: From the date of study enrollment to time of event, assessed up to 12 weeks
Change in weight, defined by body mass index as weight in kg divided by height in meters squared
Time frame: Baseline up to 12 weeks
Change in blood pressure
Time frame: Baseline up to 12 weeks
Change in heart rate
Time frame: Baseline up to 12 weeks
Change in respiratory rate
Time frame: Baseline up to 12 weeks
Change in psycho-social outcomes, assessed by the FACT-P
Time frame: Baseline up to 12 weeks
Change in psycho-social outcomes, assessed by the FACT-En
Time frame: Baseline up to 12 weeks
Change in psycho-social outcomes, assessed by the POMIS cancer fatigue short form
Time frame: Baseline up to 12 weeks
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 29 Apr 2025.
- Thomas Jefferson University HospitalLink 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.
Nicole Simone, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
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, Counseling and Therapeutic in people with Breast Carcinoma and Endometrial Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University 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 7 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 29 Apr 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?
Change in miR-21 expression assessed in serum (time frame: Baseline up to 12 weeks). 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 29 Apr 2025.