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Palonosetron

Serotonin

Serotonin 5-HT3 Receptor Antagonists

Neurotransmitter Agents

Palonosetron will be given as an intravenous bolus at the dose of 250 micrograms over 30 seconds beginning 30 minutes before chemotherapy.

Nicola Di Renzo, MD

This is an open-label, multicenter phase II study in patients with aggressive Non Hodgkin Lymphoma scheduled to receive moderately emetogenic polychemotherapy (according to modified Hesketh classification for antiemetic therapy).

Study With Palonosetron Alone in Preventing Chemotherapy-induced Nausea and Vomiting in Untreated Patients With Aggressive Non Hodgkin's Lymphomas Who Underwent Moderately Emetogenic Chemotherapy

Phase II Study With Palonosetron Alone in Preventing Chemotherapy-induced Nausea and Vomiting in Untreated Patients With Aggressive Non Hodgkin's Lymphomas Who Underwent Moderately Emetogenic Chemotherapy

Gruppo Italiano Studio Linfomi

Nicola Di Renzo

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Breast Diseases

Skin Diseases

Acute Graft Versus Host Disease

Antineoplastic Agents

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Pharmaceutical Solutions

Cyclophosphamide

The CT with Adriamycin 60 mg per m2 of Body Surface (BS) and Cyclophosphamide Infusion intravenous every 21 days, up to a total of 4 to 6 cycles + OV nutritional supplement.

The QT Adriamycin scheme 60 mg per m2 of Body Surface (SC) and Cyclophosphamide Infusion intravenous every 21 days, up to a total of 4 to 6 cycles + a placebo of the OV nutritional supplement.

The included patients received the Ocoxin-Viusid nutritional supplement at a rate of 75 ml daily (25 ml in 3 doses every 8 hours) administered after main meals diluted in milk or juice. The treatment will start a week before, it will be maintained throughout the coventional chemotherapy treatment\* and up to three weeks after the end of the treatment.

\*All patients should receive the CT Adriamycin 60 mg per m2 of Body Surface (BS) and Cyclophosphamide Infusion intravenous every 21 days, up to a total of 4 to 6 cycles according to protocols provided in the center.

CT + Ocoxin-Viusid

The included patients received the OV placebo in oral solution at a rate of 75 ml daily (25 ml in 3 doses every 8 hours), administered after main meals diluted in milk or juice. The treatment will start a week before, it will be maintained throughout the coventional chemotherapy treatment\* and up to three weeks after the end of the treatment.

\*All patients should receive the CT Adriamycin 60 mg per m2 of Body Surface (BS) and Cyclophosphamide Infusion intravenous every 21 days, up to a total of 4 to 6 cycles according to protocols provided in the center.

CT + Placebo

The purpose is to determine the efficacy of the nutritional supplement Ocoxin-Viusid oral solution (OV) in the reduction of acute toxicity of Chemotherapy (CT) treatment with patients with breast carcinoma. A randomized, double-blind phase II clinical trial was designed, with a sample of 120 patients distributed in 2 arms: 60 patients will receive the CT treatment plus the OV, 60 will receive CT plus OV placebo. The OV / placebo will be administered before, during and 3 weeks after the conclusion of the CT. A better tolerance to the treatment is expected with the addition of the nutritional supplement.

To obtain the sample size, the proportion of patients presenting adverse reactions that require interrupting chemotherapy treatment will be taken into account. In the institution, this figure is close to 15%. Since it is a dietary supplement, with extensive information on the safety of the product, the design is used in a stage of Flemming (without early stop rules). Assuming that the Ocoxin-Viusid product would clearly be declared ineffective (maximal ineffectiveness) if the proportion of patients not presenting adverse reactions was equal to less than 85% (p0), that is the maximum level of success below which the product does not shows signs of efficacy (the study does not guarantee further research) and taking a p1 value of 95%, where p1 is the minimum level of efficacy required from which the product would be declared effective (the results guarantee to continue a study phase III). Assuming an α error of 5% (probability of rejecting the null hypothesis when it is true) and β (probability of rejecting the alternative hypothesis when it is true) of 20% (the power of the test: 1 - β = 80%), It is determined to recruit a maximum number of 59 - 60 subjects. Determine a = 54, where a is the number of responses equal and below which the product is declared ineffective (H0 is accepted). And r = a + 1 is the cut-off point, that is, the number of responses from which the efficacy level ensures to continue to a phase III study. In this case we would expect to obtain a number of successes ≥ 55.

Patients will be randomized after surgery, in the chemotherapy consultation, and once they meet the established inclusion criteria. In order to achieve the masking of the research product, these have been labeled by a balanced randomized list obtained by computer, which will be in the possession of the Biostatistician of the study of the Clinical Investigations Section of INOR and the promoter. The product under study has been consecutively labeled from 1 to 120 (60 patients in each therapeutic arm).

Phase II randomized, controlled, double blind clinical trial.

A double blind. The masking will be maintained until the analysis of the data. However, access to the code will be allowed if serious adverse events arise related to the research product.

Evaluation of Ocoxin®-Viusid® in Breast Cancer

Efficacy of Ocoxin-Viusid in the Prevention of Acute Toxicity by Chemotherapy in Patients With Breast Cancer. Phase II Clinical Trial

The effect of the treatment will be evaluated from the number of interruptions of oncospecific treatment due to acute toxic reactions to chemotherapy.

Dichotomous variable that will be evaluated through the answer yes or no. In cases of negative response, the cause of non-compliance will be collected. It will be collected in the evaluation corresponding to each cycle of chemotherapy and in the final evaluation.

The effect of the treatment will be evaluated from the percentage of interruptions of oncospecific treatment due to acute toxic reactions to chemotherapy.

It will be measured through the Karnofsky Index. The Karnofsky Index will be collected in each evaluation query (score of 0-100 points at intervals of 10).

It will be measured through quality of life scale of the EORTC QLQ-C30 (general). It's a questionnaire of 30 questions divided into 3 areas: Functional capacity (physical aspect, social role, cognitive capacity, emotional and social factors; yes or no), symptoms (asthenia, pain and nausea / vomiting; from 1 to 4) and global assessment (from 1 to 10)

It will be measured through quality of life scale of the EORTC QLQ-BR23 (specific for breast cancer), it contains 31-53 questions, with a scale from 1-4 or 1-7 (bad-excellent):

-Functional scales:

Body image (BRBI) Sexual functioning (BRSEF) Sexual enjoyment (BRSEE) Future perspective (BRFU)

-Symptom scales / items

Systemic therapy side effects (BRST) Breast symptoms (BRBS) Arm symptoms (BRAS) Upset by hair loss (BRHL)

It will be determined through the Body Mass Index (BMI). The investigator must take into account that if the patient presents with ascites, she should indicate a paracentesis (whenever possible and the type of ascites allows it) before measuring her body weight.

It will be determined through the value of total proteins and albumin.

The safety of the treatment will be determined through the reporting of adverse events that are presented to the research product.

Catalysis SL

Frailty

Elderly cancer patients treated with chemotherapy will have DEXA

The appendicular muscle mass measured by DEXA

DEXA

Laurent Balardy

The investigators could hypothesize that age-related changes in body composition parameters play a role in the variable tolerance to chemotherapy in the elderly.

However none of the studies relating body composition and chemotoxicity included elderly as a specific subpopulation. Furthermore in the majority of studies, body composition analyses are based on the estimation of muscle mass by CT scanner (axial L3 section). This method is to date not validated in the elderly cancer patients. Nevertheless some studies used Dual Energy X-ray Absorptiometry (DEXA), which is considered the gold standard in the assessment of body composition in older adults.

The investigators main hypothesis is that the appendicular muscle mass (I.e. muscle mass of the 4 limbs) operationalized as an index by dividing the muscle mass by squared height following Baumgartners' approach (Baumgartner, 1998) measured by DEXA (total of muscle mass of 4 limbs / height ²) represents a predictive factor of chemotoxicity in the elderly.

The finding that body composition is associated with poor tolerance of chemotherapy could lead to consider these parameters in the treatment decision of the elderly cancer patients and improve the current decision-making algorithms when treating older adults.

Frailty and Body Composition in the Elderly Cancer Patients Treated With Chemotherapy

Toxicity event defined by : first occurrence of grade 4 hematologic or grade 3-4 non hematologic toxicity as defined by the National Cancer Institute-Common Toxicity Criteria (NCI-CTC version 4) and/or disruption of chemotherapy because of inacceptable toxicity.

defined as a loss of ≥ 0.5 point in Activities of Daily Living Scale.

defined as a loss ≥ 1 point in the Short Physical Performance Battery

defined as a loss ≥ 10 points in the EORTC quality of life questionnaire (QLQ) QLQ-C30 questionnaire

defined by a death occuring during the 3 first months from the initiation of the treatment

University Hospital, Toulouse

Bihong T. Chen, MD., Ph.D

This study will use advanced MRI techniques to characterize the changes that occur to the structure and functionality of the brain in older breast cancer patients receiving adjuvant chemotherapy, and determine the relationship between the brain changes and severity of chemotherapy toxicity. Our results will be an early step towards identifying neuroimaging markers of aging, breast cancer and chemotherapy treatment, and will contribute to our understanding of the underlying pathophysiology of cognitive changes and chemotherapy toxicity in vulnerable, older adults with cancer. Furthermore, the work will lay the foundation for future, larger scale clinical studies of cognitive changes and chemotherapy toxicity in the aging cancer population.

Breast cancer is the leading cancer diagnosed among woman in the US and is the second leading cause of cancer deaths. Adjuvant chemotherapy has been proven to decrease the risks of relapse and mortality from breast cancer. However, older adults are at increased risk for chemotherapy toxicity, including an increased risk of treatment-related mortality. At present, there is only preliminary evidence regarding which brain structures and functions are affected by chemotherapy and toxicity in breast cancer patients. However, this prior research did not specifically study older women. Thus, there is a need to establish a more sensitive test that has reproducible biomarkers, to identify the older breast cancer patients who are at higher risk for chemotherapy toxicity Our long term goal is to identify highly sensitive and reproducible brain MRI biomarkers that are associated with chemotherapy toxicity in aging cancer patients. Toward that goal, the objective of this study is to define the changes that occur on brain MRI and to determine the relationship between brain MRI changes and chemotherapy toxicity in older adults with breast cancer. We aim to 1) define structural and functional changes that occur on brain MRI of older women with breast cancer receiving adjuvant chemotherapy and; 2) determine the relationship between the severity of structural and functional changes on brain MRI and chemotherapy toxicity. We expect that the severity of structural and functional changes to the brain MRI in our patients will correlate with the severity of chemotherapy toxicity. The proposed study is significant because it focuses on the unknown relationship between brain MRI changes and chemotherapy toxicity in older women with breast cancer. It is innovative because it proposes advanced MRI techniques to study and identify the novel potential biomarkers for chemotherapy toxicity in older adults with breast cancer. It will have a positive impact by helping to clarify the underlying pathophysiology of cognitive decline caused by chemotherapy toxicity. The data generated from this pilot study will also help to serve as a foundation for future large scale studies of cognition and chemotherapy in older adults.

Brain Functional MRI in Older Women With Breast Cancer (Brain fMRI-BC)

A Pilot Study of Structural and Functional Brain Magnetic Resonance Imaging Findings of Chemotherapy Toxicity in Older Women With Breast Cancer

Prior to and after chemotherapy in older patients with breast cancer.

Secondary measures include the changes in cognitive assessment measured by NIH Toolbox cognitive testing prior to and after chemotherapy.

These secondary measures include gray matter density, fractional anisotropy (FA) and resting-state brain connectivity.

Chemotherapy toxicity as a secondary outcome measure will be captured in a standardized manner using the NCI Common Toxicity Criteria for Adverse Events (v4.0) (NCI CT CAE version 4.0). Furthermore, we will determine the association of the brain MRI parameters for both structure and function with chemotherapy toxicity in older patients with breast cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study With Palonosetron Alone in Preventing Chemotherapy-induced Nausea and Vomiting in Untreated Patients With Aggressive Non Hodgkin's Lymphomas Who Underwent Moderately Emetogenic Chemotherapy	NCT01018758	Chemotherapy-In... Non Hodgkin's L...	Palonosetron	18 Years -	Gruppo Italiano Studio Linfomi
Evaluation of Ocoxin®-Viusid® in Breast Cancer	NCT03576521	Breast Cancer Breast Carcinom... Adriamycin Toxi... Cyclosporine To...	CT + Ocoxin-Viu... CT + Placebo	18 Years -	Catalysis SL
Frailty and Body Composition in the Elderly Cancer Patients Treated With Chemotherapy	NCT02806154	Cancer	DEXA	70 Years -	University Hospital, Toulouse
Frailty and Body Composition in the Elderly Cancer Patients Treated With Chemotherapy	NCT02806154	Cancer	DEXA	70 Years -	University Hospital, Toulouse
Brain Functional MRI in Older Women With Breast Cancer (Brain fMRI-BC)	NCT01992432	Breast Cancer		65 Years -	City of Hope Medical Center
Study With Palonosetron Alone in Preventing Chemotherapy-induced Nausea and Vomiting in Untreated Patients With Aggressive Non Hodgkin's Lymphomas Who Underwent Moderately Emetogenic Chemotherapy	NCT01018758	Chemotherapy-In... Non Hodgkin's L...	Palonosetron	18 Years -	Gruppo Italiano Studio Linfomi

Spots Global Cancer Trial Database for chemotherapy toxicity