Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Antineoplastic Agents

Antirheumatic Agents

Anti-Infective Agents

Metformin

Paclitaxel

Albumin-Bound Paclitaxel

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Taxane

Tubulin Modulators

Antimitotic Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Experimental Arm A will consist of 6 months of standard anthracycline-taxane preoperative chemotherapy in combination with triweekly cycles of 5-day FMD.

Chemotherapy will consist of:

* four triweekly cycles of doxorubicin 60 mg/mq plus cyclophosphamide 600 mg/mq, followed by
* twelve consecutive cycles of weekly paclitaxel 80 mg/mq

The FMD will consist of a triweekly 5-day regimen of a plant-based, calorie-restricted (600 KCal on day 1; 300 KCal on days 2-5), low-carbohydrate, low-protein diet. The FMD will be repeated up to a maximum of eight consecutive cycles.

Experimental Arm B will consist of 6 months of standard anthracycline-taxane preoperative chemotherapy in combination with triweekly cycles of 5-day FMD and daily metformin

Chemotherapy will consist of:

* four triweekly cycles of doxorubicin 60 mg/mq plus cyclophosphamide 600 mg/mq, followed by
* twelve consecutive cycles of weekly paclitaxel 80 mg/mq

The FMD will consist of a triweekly 5-day regimen of a plant-based, calorie-restricted (600 KCal on day 1; 300 KCal on days 2-5), low-carbohydrate, low-protein diet. The FMD will be repeated up to a maximum of eight consecutive cycles.

Metformin will be administered at an initial dosage of 850 mg/dya, and then escalated to the maximum dosage of 1700/day (two 850 mg tablets) if well tolerated. Metformin will be interrupted 7 days before surgery.

Cyclic, 5-day, calorie-restricted (600 KCal on day 1; 300 KCal on days 2-5), low-carbohydrate, low protein diet every three weeks

Fasting-mimicking diet

Chemotherapy will consist of:

* four triweekly cycles of doxorubicin 60 mg/mq plus cyclophosphamide 600 mg/mq, followed by
* twelve consecutive cycles of weekly paclitaxel 80 mg/mq

Preoperative chemotherapy

Filippo de Braud, Professor

Claudio Vernieri, M.D. PhD

Glucose starvation and metformin have synergistic antitumor effects that are mediated through the concomitant inhibition of glycolysis and mitochondrial oxidative phosphorylation. The BREAKFAST trial will evaluate the antitumor activity of combining cyclic fasting-mimicking diet (FMD), which reproduces the in vitro effects of glucose starvation, plus/minus metformin with standard preperative anthracycline-taxane chemotherapy in patients with stage I-III TNBC

Triple-negative breast cancer (TNBC) is the most aggressive breast cancer subtype, and is associated with the lowest cure rates in the limited-stage disease setting, as well as with the lowest overall survival in the metastatic setting. Preclinical studies indicate that cycles of fasting or calorie-restricted, low-carbohydrate, low-protein diets, also known as fasting-mimicking diets (FMDs), have synergistic cytotoxic effects when combined with chemotherapy agents, such as doxorubicin or cisplatin, in several in vitro and in vivo tumor models, including murine TNBC models. More recently, intermittent fasting has demonstrated highly synergistic antitumor effects when combined with metformin; of note, these effects are mediated through the concomitant inhibition of glycolysis (via fasting-induced hypoglycemia) and metformin-induced inhibition of mitochondrial oxidative phosphorylation (OXPHOS). Finally, small reports published so far indicate that cyclic fasting and FMDs are well tolerated in cancer patients, and can be safety combined with standard antitumor treatments.

Based on these data, the BREAKFAST trial was designed to investigate the antitumor activity of cyclic FMD, alone or in combination with metformin, in patients with localized TNBC. In this study, 90 patients with stage I-III TNBC will be randomized in a 1:1 ratio to receive approximately 6 months of standard preoperative anthracycline plus taxane chemotherapy in combination with eight triweekly cycles of 5-day FMD (Arm A), or the same chemotherapy-FMD regimen plus daily metformin (Arm B). The primary objective of the study is to demonstrate that one or both experimental treatments increase the rate of pCR from 45% (historical data) to 65%

Calorie Restriction With or Without Metformin in Triple Negative Breast Cancer

Targeting Triple Negative BREAst Cancer Metabolism With a Combination of Chemotherapy and a Diet Mimicking FASTing Plus/Minus Metformin in the Preoperative Setting: the BREAKFAST Trial

Rate of pathologic complete responses (pCRs)

Incidence of severe (grade 3 or 4) adverse events according to CTCAE v 5.0

Incidence of treatment-related adverse events (AEs)

Patients' ability to adhere to the prescribed FMD regimen and pharmacological treatment according to the analysis of daily food diaries and diaries related to metformin intake

Short-term modifications of plasma glucose levels, as defined as changes in peripheral blood venous plasma glucose concentration before and after each FMD cycle

Long-term modifications of plasma glucose concentration, as defined as changes in peripheral blood venous plasma glucose concentration measured before consecutive FMD cycles

Short-term modifications of serum insulin concentration, as defined as changes in peripheral blood venous serum insulin concentration before and after each FMD cycle

Long-term modifications of serum insulin concentration, as defined as changes in peripheral blood venous serum insulin concentration measured before consecutive FMD cycles

Short-term modifications of serum IGF-1 concentration, as defined as changes in peripheral blood venous serum IGF-1 concentration before and after each FMD cycle

Long-term modifications of blood IGF-1 concentration, as defined as changes in serum IGF-1 concentration measured before consecutive FMD cycles

Short-term modifications of blood lipid profile, as defined as changes in plasma lipids before and after individual FMD cycles

Long-term modifications of blood lipid profile, as defined as changes in plasma lipids assessed before consecutive FMD cycles

To estimate clinical tumor responses, as assessed through Magnetic Resonance Imaging (MRI) evaluations according to RECIST 1.1 criteria before surgery

To correlate baseline metabolic gene expression, as assessed through RNA-seq analysis, with patient probability to achieve a pCR. In particular, the expression of genes encoding for catalytic, regulatory and scaffolding subunits of PP2A will be evaluated.

To correlate mutational tumor profiles, as assessed through whole-genome sequencing analysis, with patient probability to achieve a pCR. In particular, the expression of genes encoding for catalytic, regulatory and scaffolding subunits of PP2A will be evaluated.

Short-term modifications of plasma amino acid profile, as defined as changes in plasma amino acids before and after individual FMD cycles

Long-term modifications of plasma amino acid profile, as defined as changes in plasma amino acids assessed before consecutive FMD cycles

IFOM ETS - The AIRC Institute of Molecular Oncology

European Institute of Oncology

University of Milan

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Blood and Lymph Conditions

Symptoms and General Pathology

Wounds and Injuries

Rare Diseases

Hematologic Neoplasms

Hyperthermia

Neutropenia

Fever

Febrile Neutropenia

Hematologic Diseases

Agranulocytosis

Leukopenia

Cytopenia

Leukocyte Disorders

Granulocytopenia

This cohort will place BioStickers at least 3 days prior to completion of standard of care therapy and discharge home post therapy.

The BioSticker is an FDA approved medical device which can be worn on the upper left chest for remote data capture and can provide for up 30 days of continuous vital sign monitoring

BioSticker

Glen Peterson

BioSticker data is remotely tracked and displayed in a report termed the BioReport for retrospective data analysis. Typically, the biosensor collects data on an interval of \~1 minute and this data is collated and reported remotely back to the BioReport every 6 hours. More importantly, for future applications of the BioSticker for early detection of FN, there are ongoing efforts to implement real time reporting and alarms using remote monitoring services that could alert the patient that they need to seek medical care. There are no known deleterious effects from the BioSticker and it is now being widely used and tested in diverse applications including detection and contact tracing of COVID and others.

The BioIntelliSense BioSticker potentially offers a solution to these challenges through early and reliable detection of elevated temperature and perhaps other relevant physiologic changes. The BioSticker is an FDA approved medical device which can be worn on the upper left chest for remote data capture and can provide for up 30 days of continuous vital sign monitoring (see https://biointellisense.com as well as attached documents on BioSticker instructions for a full description and use instructions). The BioSticker detects the following:

* Respiratory rate, heart rate at rest and skin temperature
* Body position, activity levels, sleep status
* High-resolution gait analysis and fall detection
* Symptomatic events

BioSticker data is remotely tracked and displayed in a report termed the BioReport for retrospective data analysis. Typically, the biosensor collects data on an interval of \~1 minute and this data is collated and reported remotely back to the BioReport every 6 hours. More importantly, for future applications of the BioSticker for early detection of FN, there are ongoing efforts to implement real time reporting and alarms using remote monitoring services that could alert the patient that they need to seek medical care. There are no known deleterious effects from the BioSticker and it is now being widely used and tested in diverse applications including detection and contact tracing of COVID and others.

Remote Temperature Data for Early Detection of Febrile Neutropenia

Remote Data Capture of Elevated Temperature Data for Early Detection of Febrile Neutropenia in Patients With Hematologic Malignancies

Patients will self-temperature check every 6 hours or at least two times per day, and will log these temperatures in a paper record with date, time and temperature noted.

Patients will report a single oral temperature of ≥38.3°C (101°F) or a temperature of ≥38.0°C (100.4°F) sustained over a one-hour period to our clinic nurses or 24/7 on-call advanced practitioner and will be directed to the Emergency Department or clinic for initiation of antibiotics and FN work-up and management as per usual practice.

Hospitalization during the 28 days will be extracted from the medical record

ICU transfers during the 28 days will be extracted from the medical record

Delays in chemotherapy during the 28 days will be extracted from the medical record

BioIntelliSense, Inc

University of Colorado, Denver

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Immune System Diseases

Carcinoma

Prostatic Neoplasms

Neoplasm Metastasis

Hypersensitivity

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Micronutrients

Vitamins

Androgens

Hormones

Androgen Antagonists

Ascorbic Acid

Methyltestosterone

Testosterone

Testosterone undecanoate

Testosterone enanthate

Testosterone 17 beta-cypionate

Estrogens, Conjugated (USP)

Estrogens

Hormone Antagonists

Antioxidants

Protective Agents

Trace Elements

Antineoplastic Agents, Hormonal

Anabolic Androgenic Steroids

Anabolic Agents

Vitamin C

Patients undergo an FDG-PET scan after 6 months of SOC cytotoxic chemotherapy + ADT. Patients with PET-avid disease continue their SOC ADT and undergo MDRT to up to 5 disease sites in the absence of unacceptable toxicity. Patients also undergo CT and bone scans throughout the trial.

Patients undergo an FDG-PET scan after 6 months of SOC cytotoxic chemotherapy + ADT. Patients with PET-avid disease continue their SOC ADT on study. Patients also undergo CT and bone scans throughout the trial.

Patients undergo an FDG-PET scan after 6 months of SOC cytotoxic chemotherapy + ADT. Patients without PET-avid disease continue their SOC ADT on study. Patients also undergo CT and bone scans throughout the trial.

Patients undergo an FDG-PET scan after 6 months of SOC ADT. Patients with PET-avid disease continue their SOC ADT and undergo MDRT to up to 5 disease sites in the absence of unacceptable toxicity. Patients undergo an additional FDG-PET scan at 6 months. Patients also undergo CT and bone scans throughout the trial.

Patients undergo an FDG-PET scan after 6 months of SOC ADT. Patients with PET-avid disease continue their SOC ADT on study and undergo an additional FDG-PET scan at 6 months. Patients also undergo CT and bone scans throughout the trial.

Patients undergo an FDG-PET scan after 6 months of SOC ADT. Patients without PET-avid disease continue their SOC ADT on study and undergo an additional FDG-PET scan at 6 months. Patients also undergo CT and bone scans throughout the trial.

Antiandrogen Therapy

Bone Scan

Computed Tomography

Cytotoxic Chemotherapy

FDG-Positron Emission Tomography

Radiation Therapy

Study Coordinator

David VanderWeele

David VanderWeele, MD, PhD

This phase II trial compares the effect of FDG-positron emission tomography (PET)-guided metastasis directed radiation therapy (MDRT) in combination with standard treatments to standard treatments alone in treating patients with prostate cancer that is sensitive to androgen-deprivation therapy (ADT) and has spread from where it first started (primary site) to other places in the body (metastatic). Prostate cancer is the second leading cause of cancer death among men in the United States, despite the approval of several life-prolonging treatments by the Food and Drug Administration. However, over the past 10 years, there have been significant improvements in prolonging the lives of those with metastatic hormone sensitive prostate cancer, specifically by adding treatments to standard therapy, such as ADT. More recently, trials have demonstrated a benefit of using radiotherapy (high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors) to delay the progression of cancer and prolong life for patients with metastatic disease. Imaging scans with FDG-PET may be able to identify cancer sites that remain active despite standard treatment. Giving MDRT plus standard treatment to patients with FDG-PET-identified cancer sites may work better than standard treatment alone in treating metastatic hormone sensitive prostate cancer.

PRIMARY OBJECTIVES:

I. To compare the progression free survival (PFS) between standard of care (SOC) + MDRT (Arm 1A) versus (vs) SOC alone (Arm 1B). (Cohort 1 \[cytotoxic therapy cohort\]) II. To compare the proportions of patients in Arm 2A vs Arm 2B who attain complete response (CR) 6 months after randomization. (Cohort 2 \[non-cytotoxic therapy cohort\])

SECONDARY OBJECTIVES:

I. To compare the radiographic progression-free survival (rPFS) between Arms 1A and 1B. (Cohort 1 \[cytotoxic therapy cohort\]) II. To determine the proportions of patients with metastatic hormone sensitive prostate cancer (mHSPC) who achieve a serum prostate-specific antigen (PSA) level \< 4 ng/mL and \< 0.01 ng/mL and compare them between Arm 1A and 1B. (Cohort 1 \[cytotoxic therapy cohort\]) III. To determine the proportion of patients with skeletal related events (SRE), and compare them between Arms 1A and 1B. (Cohort 1 \[cytotoxic therapy cohort\]) IV. To assess the safety and toxicity of MDRT during and following MDRT completion. (Cohort 1 \[cytotoxic therapy cohort\]) V. To determine the objective response rate (ORR), defined as the proportion of patients who experience a confirmed complete response (CR) or confirmed partial response (PR) on fludeoxyglucose F-18 (FDG)-PET-2, and to compare ORR between Arms 2A and 2B. (Cohort 2 \[non-cytotoxic therapy cohort\]) VI. To determine the progression-free survival (PFS) and radiographic progression-free survival (rPFS), and to compare between Arms 2A and 2B. (Cohort 2 \[non-cytotoxic therapy cohort\]) VII. To determine the proportions of patients with mHSPC who achieve a serum PSA level \< 4 ng/mL and \< 0.01 ng/mL (undetectable), and compare them between Arms 2A and 2B. (Cohort 2 \[non-cytotoxic therapy cohort\]) VIII. To determine the proportion of patients with skeletal related events (SRE), and compare them between Arms 2A and 2B. (Cohort 2 \[non-cytotoxic therapy cohort\]) IX. To assess the safety and toxicity of MDRT during and following MDRT completion. (Cohort 2 \[non-cytotoxic therapy cohort\])

EXPLORATORY OBJECTIVES:

I. To examine association between imaging features and progression free survival (Cohort 1) or likelihood of response (Cohort 2).

II. To determine the time to treatment discontinuation (TTD) in Cohort 1 Arm 1A, 1B, and 1C, and Cohort 2 Arms 2A, 2B and 2C.

OUTLINE: Patients undergoing cytotoxic chemotherapy are assigned to Cohort 1, while patients not undergoing cytotoxic chemotherapy are assigned to Cohort 2.

COHORT 1: Patients undergo an FDG-PET scan after 6 months of SOC cytotoxic chemotherapy + androgen deprivation therapy (ADT). Patients with PET-avid disease are randomized to Arm 1A or 1B. Patients without PET-avid disease are assigned to Arm 1C.

ARM 1A: Patients continue their SOC ADT and undergo MDRT to up to 5 disease sites in the absence of unacceptable toxicity. Patients also undergo computed tomography (CT) and bone scans throughout the trial.

ARM 1B: Patients continue their SOC ADT on study. Patients also undergo CT and bone scans throughout the trial.

ARM 1C: Patients continue their SOC ADT on study. Patients also undergo CT and bone scans throughout the trial.

COHORT 2: Patients undergo an FDG-PET scan after 6 months of SOC ADT. Patients with PET-avid disease are randomized to Arm 2A or 2B. Patients without PET-avid disease are assigned to Arm 2C.

ARM 2A: Patients continue their SOC ADT and undergo MDRT to up to 5 disease sites in the absence of unacceptable toxicity. Patients undergo an additional FDG-PET scan at 6 months. Patients also undergo CT and bone scans throughout the trial.

ARM 2B: Patients continue their SOC ADT on study and undergo an additional FDG-PET scan at 6 months. Patients also undergo CT and bone scans throughout the trial.

ARM 2C: Patients continue their SOC ADT on study and undergo an additional FDG-PET scan at 6 months. Patients also undergo CT and bone scans throughout the trial.

After completion of study treatment, patients are followed up at 3 months (Arms 1A, 1B, 2A, 2B only) and 6 months, and then every 6 months until 36 months.

FDG-PET-Guided Metastasis Directed Radiation Therapy for the Treatment of Metastatic Hormone Sensitive Prostate Cancer, The PRTY Trial

A Randomized Open Label Phase II Trial of FDG-PET-Guided Metastasis Directed Therapy in Patients With Metastatic Hormone Sensitive Prostate Cancer: PRTY Trial: PET- Guided Radiotherapy Consolidation

Will be estimated using the method of Kaplan-Meier and compared between treatment arms (Arms 1A and 1B) using the log-rank test. PFS rate at 18 months following randomization will be estimated and reported with the corresponding confidence intervals.

Will be estimated as the proportion of patients who demonstrate response based on fludeoxyglucose F-18-positron emission tomography (FDG-PET)-2 as compared to baseline (FDG-PET-1), and will be reported with the corresponding Clopper-Pearson confidence intervals. Response rates will be compared between Arms 2A and 2B using Fisher's exact test.

Will be estimated using the method of Kaplan-Meier and compared between treatment arms (Arms 1A and 1B) using the log-rank test. rPFS rate at 18 months following randomization will be estimated and reported with the corresponding confidence intervals.

Will be compared using the Fisher's exact test, and estimates by arm will be reported with the corresponding Clopper-Pearson confidence intervals.

Will be summarized by arm using the Common Terminology Criteria in Adverse Events (CTCAE) version (v) 5.0 system organ class and term. For each subject, highest AE grade across multiple occurrences of the same event will be recorded, and the number of patients will be summarized by AE type and grade.

Defined as the proportion of patients who experience a complete response or partial response on FDG-PET-2. Will be summarized by arm and compared between Arms 2A and 2B.

Will be estimated using the method of Kaplan-Meier and compared between treatment arms (Arms 2A and 2B) using the log-rank test. PFS and rate at key time points, e.g. 6 and 18 months following randomization, will be estimated and reported with the corresponding confidence intervals.

Will be estimated using the method of Kaplan-Meier and compared between treatment arms (Arms 2A and 2B) using the log-rank test. rPFS at key time points, e.g. 6 and 18 months following randomization, will be estimated and reported with the corresponding confidence intervals.

Will be summarized by arm and compared between Arms 2A and 2B.

Will report frequency of adverse events by grade ≥ 2 assessed according to the CTCAE v 5.0.

National Cancer Institute (NCI)

Northwestern University

ascorbic acid 1.5 g/kg body weight infused over 90 to 120 minutes two or three times weekly concurrent with standard cytotoxic chemotherapy individually selected for each patient by the treating oncologist on the basis of best current clinical practice

vitamin C (ascorbic acid)

Leonard John Hoffer, MD PhD

Concurrent administration of intravenous vitamin C (ascorbic acid, 1.5 g/kg, infused two or three times weekly) together with certain cytotoxic chemotherapy regimens could prove to be an effective treatment for some patients with advanced malignancies for whom existing chemotherapy is usually ineffective. The primary objectives of this study are to identify a tolerable and safe dose of intravenous vitamin C when administered during cytotoxic chemotherapy while attempting to empirically identify specific vitamin C-chemotherapy regimens for which the clinical response is unusually favorable after a minimum of 2 months of therapy, as determined by CT scan and biomarkers, when appropriate.

Cytotoxic chemotherapy is relatively ineffective for a large proportion of common cancers. Combining redox active molecules with certain chemotherapy regimens could increase their anti-cancer activity or protect host tissues from toxicity with no loss of anti-cancer activity. Research in this area has been advocated by cancer organizations, but previous clinical trials of combination chemotherapy and antioxidant therapy been small, poorly designed, and unsystematic. Appropriate study of this treatment concept requires a systematic, meticulous empirical approach similar to the one used in conventional cytotoxic drug discovery. This is a Phase I-II study designed to identify promising chemotherapy-antioxidant protocols and determine their acceptability and limiting toxicity in patients with relentlessly progressive cancers for which conventional chemotherapy is clinically indicated but is known to be minimally or marginally effective.

The tolerable dose of intravenous ascorbic acid (IVAA) for cancer patients with normal renal function not receiving chemotherapy is 1.5 g/kg per 90 to 120 minute infusion (Hoffer et al, Ann Oncol 2008;19:1969-1974). Side effects are minimal to non-existent. In this dose-escalating study the IVAA will be 0.9 g/kg per infusion for the first chemotherapy cycle, increasing to 1.5 g/kg per infusion in subsequent cycles, for the first 3 participants. If well tolerated as expected, the initial dose will be 1.5 g/kg per infusion for subsequent participants. Infusions will take place 2 or 3 times per week, bracketing the days of chemotherapy. Standard tolerance and adverse effect criteria will be used. Therapy will continue for a minimum of 2 months, and continue further in the event of disease stabilization or response, as determined from CT scan and biomarkers, with evaluations continuing every 2 months.

Trial of Chemotherapy Plus Intravenous Vitamin C in Patients With Advanced Cancer for Whom Chemotherapy Alone is Only Marginally Effective

Phase I - II Clinical Trial of Combination Conventional Cytotoxic Chemotherapy and Intravenous Vitamin C in Patients With Advanced Cancer or Hematologic Malignancy for Whom Cytotoxic Chemotherapy Alone is Only Marginally Effective

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Calorie Restriction With or Without Metformin in Triple Negative Breast Cancer	NCT04248998	Triple-negative...	Fasting-mimicki... Metformin Preoperative ch...	18 Years - 75 Years	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Remote Temperature Data for Early Detection of Febrile Neutropenia	NCT05180838	Hematologic Mal...	BioSticker	18 Years - 80 Years	University of Colorado, Denver
FDG-PET-Guided Metastasis Directed Radiation Therapy for the Treatment of Metastatic Hormone Sensitive Prostate Cancer, The PRTY Trial	NCT06244004	Castration-Sens... Metastatic Pros... Stage IVB Prost...	Antiandrogen Th... Bone Scan Computed Tomogr... Cytotoxic Chemo... FDG-Positron Em... Radiation Thera...	18 Years -	Northwestern University
FDG-PET-Guided Metastasis Directed Radiation Therapy for the Treatment of Metastatic Hormone Sensitive Prostate Cancer, The PRTY Trial	NCT06244004	Castration-Sens... Metastatic Pros... Stage IVB Prost...	Antiandrogen Th... Bone Scan Computed Tomogr... Cytotoxic Chemo... FDG-Positron Em... Radiation Thera...	18 Years -	Northwestern University
FDG-PET-Guided Metastasis Directed Radiation Therapy for the Treatment of Metastatic Hormone Sensitive Prostate Cancer, The PRTY Trial	NCT06244004	Castration-Sens... Metastatic Pros... Stage IVB Prost...	Antiandrogen Th... Bone Scan Computed Tomogr... Cytotoxic Chemo... FDG-Positron Em... Radiation Thera...	18 Years -	Northwestern University
Remote Temperature Data for Early Detection of Febrile Neutropenia	NCT05180838	Hematologic Mal...	BioSticker	18 Years - 80 Years	University of Colorado, Denver
Trial of Chemotherapy Plus Intravenous Vitamin C in Patients With Advanced Cancer for Whom Chemotherapy Alone is Only Marginally Effective	NCT01050621	Cancer	vitamin C (asco...	18 Years -	Jewish General Hospital
Calorie Restriction With or Without Metformin in Triple Negative Breast Cancer	NCT04248998	Triple-negative...	Fasting-mimicki... Metformin Preoperative ch...	18 Years - 75 Years	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
FDG-PET-Guided Metastasis Directed Radiation Therapy for the Treatment of Metastatic Hormone Sensitive Prostate Cancer, The PRTY Trial	NCT06244004	Castration-Sens... Metastatic Pros... Stage IVB Prost...	Antiandrogen Th... Bone Scan Computed Tomogr... Cytotoxic Chemo... FDG-Positron Em... Radiation Thera...	18 Years -	Northwestern University

Spots Global Cancer Trial Database for cytotoxic chemotherapy