Status:
TERMINATED
RCT of Caloric Restriction vs. Alternate-Day Fasting in Non-Alcoholic Fatty Liver Disease
Lead Sponsor:
University of Florida
Conditions:
NAFLD
Obesity
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Non-alcoholic fatty liver disease (NAFLD) in patients with diabetes (T2DM) is increasing in prevalence and can lead to cirrhosis. Lifestyle intervention with caloric restriction (CR) is the cornerston...
Detailed Description
Rationale: Non alcoholic fatty liver disease (NAFLD) has a prevalence of up to 80% in patients with T2DM and obesity and can lead to steatohepatitis (NASH) and fibrosis as well as cirrhosis and hepat...
Eligibility Criteria
Inclusion
- Patient must give study-specific informed consent on an IRB-approved consent prior to any research related procedures or study treatment.
- Patient must be at least 18 years at the time of consent Adenocarcinoma of the prostate with AJCC Clinical Stage T1to T3b disease with histological evaluation via biopsy or repeat biopsy within 12 months prior to registration. Refer to Appendix IV for clarification on study eligibility and AJCC stage group.
- Patients must undergo a pretreatment diagnostic MRI of the prostate on a 1.5T to 3T Tesla machine within 6 months prior to study registration.
- A focal IPT must be visible on MRI within the prostate and/or seminal vesicles and this MRI must be obtained within 6 months of planning CT scan.
- A biopsy of the dominant lesion is recommended but not required. If an ultrasound guided sextant biopsy was positive for prostatic adenocarcinoma in the area of the MRI identified intraprostatic lesion, this will be acceptable and another guided biopsy targeting the MRI identified disease will not be necessary.
- Patients with at least one of the following high-risk factors: cT3a-T3b OR Gleason 9-10 OR PSA \> 30 OR more than 1 high-risk factors must be present: clinical stage of T3, Gleason score 8-10, or PSA 20 ng/ml or greater.
- Hemoglobin must be ≥ 10 g/ml within 4 months prior to registration.
- Zubrod performance status must be 0-1 within 4 months prior to registration.
- If patient has child-producing potential, they must be willing to use medically acceptable contraception during treatment and must be advised to use it for at least 1 year thereafter. This is not applicable if the patient is not sexually active or has had a vasectomy. Please document as such.
- Patients must be able to start treatment within 16 weeks of registration.
Exclusion
- T4 prostate disease on CT, MRI, or physical exam.
- Patients unable to undergo MRI of the prostate.
- Patients with a greater than 25% change in prostate volume from the pretreatment MRI of the prostate demonstrating the IPT and the treatment planning MRI. Patients in this case must undergo a repeat diagnostic MRI on a 1.5T to 3.0T Tesla machine and an IPT must still be visible.
- IPT that is more than 75% of the prostate volume when measured on the CT simulation scan.
- Evidence of distant metastasis (M1).
- Patients with positive nodes on cross-sectional imaging.
- Previous prostate cancer local treatment including prostatectomy, hyperthermia, high intensity focused ultrasound, brachytherapy, external-beam radiation therapy, and/or cryotherapy.
- Prior pelvic radiation therapy.
- No prior myocardial infarction within the last 6 months, congestive heart failure, or end stage renal disease.
- Active inflammatory bowel disease (diverticulitis, Crohn's disease, ulcerative colitis) affecting the rectum.
- Bilateral hip replacement
- Prior intrapelvic surgery. This includes the following:Bladder surgery,Transrectal or rectal surgery other than prostate biopsy, Polypectomy or hemorrhoid removal or banding
- Prior transurethral resection of the prostate (TURP) or laser ablation for benign prostatic hyperplasia (BPH).
- Patients receiving continuous and current anticoagulation with warfarin sodium (Coumadin), heparin sodium, clopidogrel bisulfate (Plavix), dabigatran etexilate mesylate (Pradaxa), rivaroxaban (Xarelto), apixaban (Eliquis), edoxaban (Savaysa), enoxaparin sodium (Lovenox), prasugrel (Effient), ticagrelor (Brilinta), aspirin/er dipyridamole (Aggrenox), or fondaparinux sodium (Arixtra).
- Patients with posterior or posterolateral extracapsular extension of prostate cancer. If this is present, it must resolve on diagnostic MRI after 2 to 3 months of neoadjuvant androgen deprivation therapy prior to enrollment. Refer to Appendix V for definition of extracapsular extension
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2019
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03365531
Start Date
March 1 2018
End Date
July 1 2019
Last Update
September 23 2019
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610