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Short-Term Fasting Prior to Platinum-Based Chemotherapy: Feasibility and Impact on Toxicity.
Open to Accrual
Defintions of terms and FAQ about clinical trials.
Tanya Dorff, M.D.
Other Trial Staff:
Charlean Ketchens, R.N., Lagrimas Ilagan, D.M., Francisco Acosta, D.M.
to see study documents.
You may participate in this study if:
Histologically confirmed solid tumor for which platinum-based chemotherapy on a 21-day cycle or 14-day cycle is being recommended
At least 18 years of age
Disease state: Stage I of the trial: newly diagnosed disease for which neoadjuvant or adjuvant chemotherapy is planned in the curative setting, or metastatic disease. Stage II of the trial: Measurable disease (metastatic) by RECIST criteria must be present for all subjects in the randomized component of the trial – if surgery or radiation is planned, the target lesions may not be so treated until after the assessment of the effect of chemotherapy.
Prior chemotherapy: Stage I: subjects may have already received no more than 2 cycles of their platinum-based chemotherapy but should not have received other prior chemotherapy regimens with the exception of patients with metastatic disease who received neoadjuvant or adjuvant chemotherapy and that chemotherapy was completed >6 months prior to enrollment. Stage II: chemotherapy-naïve for metastatic disease. May have received prior neoadjuvant or adjuvant chemotherapy, provided such therapy was completed >6 months prior to enrollment.
Prior RT: allowed, provided at least 2 weeks have elapsed from completion of RT to initiation of protocol treatment
BMI = / > 20.5
ECOG performance status 0-1
Creatinine < / = 1.25 x uln or calculated CrCl >50 ml/min
Pre-menopausal women must have a negative pregnancy test and must agree to use barrier contraception throughout the study period
Signed an approved study-specific informed consent and HIPAA
You may not participate in this study if:
Weight loss >10% of body weight in the year prior to planned chemotherapy
Peripheral neuropathy > / = Gr 1
History of significant cardiac disease, particularly uncompensated CHF NYHA Gr 2 or more or LVEF < 40% on any prior assessment.
Subjects on medications that may not be safely stopped during the fasting portion of the study, or which may not be safely consumed without food
History of syncope with calorie restriction in the past or other medical co-morbidity, which would make fasting potentially dangerous
For further information on a study, please contact the Clinical Investigation Support Office at (323) 865-0451, or
To schedule a consultation with the hospital, please call our New Patient Referrals Office at (323) 865-3111.