Régime contrôlé avant chimiothérapie pour le cancer du sein et de la prostate
Cette étude vise à évaluer si un régime alimentaire contrôlé avant la chimiothérapie peut réduire les effets secondaires liés au traitement chez les personnes atteintes de cancer du sein ou de la prostate.
dietary intervention
+ laboratory biomarker analysis
+ nutritional support
Maladies génito-urinaires+11
+ Maladies Génitales
+ Maladies du sein
Soins de support
Résumé
Date de début de l'étude : 29 janvier 2013
Date à laquelle le premier participant a commencé l'étude.PRIMARY OBJECTIVES: I. To obtain preliminary estimates of the impact of a restricted diet on toxicity and efficacy of chemotherapy for breast and prostate cancer. II. To evaluate the compliance with a controlled diet intervention. III. To investigate changes in plasma insulin, glucose, insulin-like growth factor 1 (IGF1) and IGF binding protein (IGFBP) levels in subjects who consume a restricted diet compared to controls. OUTLINE: Patients are randomized to 1 or 2 treatment arms. ARM I: Patients eat a special low-calorie diet during 3 days prior to chemotherapy, during the 12 weeks of chemotherapy, and 24 hours after chemotherapy. Patients are provided with all meals and all food to be consumed and maintain a diary of the food consumed and appropriate amounts. Patients meet with the study dietician within 3 weeks of enrollment and prior to, or on the day of, their first course of chemotherapy on study and at the start of each subsequent course. ARM II: Patients eat a normal diet and receive dietary advice which may include consultation with a nutritionist. Patients maintain a diary of the food consumed and appropriate amounts.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.130 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Soins de support
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 19 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: * Histologically confirmed breast cancer for which chemotherapy with AC (doxorubicin plus cyclophosphamide) is being utilized in the neoadjuvant or adjuvant setting OR metastatic prostate adenocarcinoma for which Docetaxel will be administered * Body mass index (BMI) \>= 18.5 * Subjects do not need to have measurable or evaluable disease; chemotherapy may be administered in the neoadjuvant, adjuvant, or metastatic setting * Prior therapy: * Breast cancer subjects may not have received prior chemotherapy, with the exception of curative-intent chemotherapy for a separate malignancy more than 3 years ago * Prostate cancer subjects may have received prior treatment with metronomic cyclophosphamide as this is considered anti-angiogenic/immunomodulatory and not cytotoxic * Prostate cancer subjects may be receiving a 2nd course of docetaxel provided that \*\* The first course resulted in a PSA response (\> 30% reduction in prostate specific antigen \[PSA\] and/or improvement in radiographic findings or pain) and the last dose was \>= 9 months ago * Prior Radiotherapy is allowed, provided at least 2 weeks have elapsed from completion of radiotherapy to initiation of protocol treatment * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2x upper limit of normal (ULN) * Absolute neutrophil count (ANC) \> 1500 * Platelets (plts) \> 90,000 * Premenopausal women must have a negative pregnancy test and must agree to use barrier contraception throughout the study period Exclusion Criteria: * Diabetes Mellitus * Peripheral Neuropathy \>= grade 1 * Prior therapy with inhibitors of IGF-1 * Concurrent use of somatostatin * Significant food allergies which would make the subject unable to consume the food provided (ex: shellfish, soy or egg allergy)
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalGroupe II
Comparateur actifObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 3 sites
USC Norris Comprehensive Cancer Center
Los Angeles, United StatesOuvrir USC Norris Comprehensive Cancer Center dans Google MapsUSC Norris Oncology/Hematology-Newport Beach
Newport Beach, United StatesMayo Clinic Rochester
Rochester, United States