- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01596439
A Prospective Study to Evaluate the Effect of Systemic Adjuvant Therapy on the Cognitive Function of Breast Cancer Patients
The primary objective of this prospective pilot study is to examine the variation of cognitive function at various time-points in stage I-III breast cancer patients who have undergone or are undergoing adjuvant systemic therapy (chemotherapy and/or anti-hormonal therapy) and compare this to a group of healthy controls to evaluate if there is a difference. All randomized patients and their respective controls would be required to complete the computerized neuropsychological assessment CANTAB at certain time-points.These patients and controls would also be given on the same day as CANTAB testing, a set of questionnaires to evaluate subjective factors such as anxiety, depression, fatigue or menopausal symptoms which may also have an effect on cognition. Subjective assessment of cognitive function will rely on self-reporting by study participants using a validated questionnaire.The potential risks to subjects are minimal, as this is a study without any intervention regarding the medical management of patients. By participating in this study, subjects will be helping in the aim of determining if there is cognitive impairment post-therapy, and if so, how prevalent is this phenomenon, when it arises and how it changes with time. This will consequentially play an important role with regard to patient knowledge. Furthermore, if chemotherapy is shown to be associated with cognitive impairment, further studies can be carried out to determine the exact pathophysiology behind this phenomenon. This will allow for sensitive and timely detection of cognitive dysfunction in patients who have received chemotherapy and/or anti-hormonal therapy, and subsequently open the avenue for research in preventing or alleviating this phenomenon. This is crucial in improving patients' quality of life, social and occupational performance.
The investigators hypothesis is that systemic adjuvant therapy in the form of chemotherapy and/or anti-hormonal therapy given to primary breast cancer patients can cause cognitive impairment.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
-
-
-
Singapore, Singapour
- Recrutement
- Nationa University Hospital
-
Contact:
- Sing Huang Tan, MBBS
- Numéro de téléphone: +65 6779 5555
- E-mail: Sing_Huang_Tan@nuhs.edu.sg
-
Chercheur principal:
- Sing Huang Tan, MBBS
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Histologically confirmed stage I-III breast carcinoma
- < 65 years old
- Female
Exclusion Criteria:
- Previous exposure to chemotherapy/anti-hormonal therapy for any other malignancy
- Previous neoadjuvant therapy for breast cancer
- Concomitant second primary in-situ or invasive carcinoma or previous history of carcinoma/carcinoma-in-situ
- Known disease or injury to the central nervous system (including neurodegenerative diseases, epilepsy), severe visual or auditory disorders
- Motor weakness due to any cause which makes using a touchscreen computer difficult
- Known background of depression, anxiety disorders or other neurobehavioural conditions
- Ongoing use of tranquilisers or anti-depressants
- Previous neuropsychological testing
- Current or previous history of alcohol or drug dependent
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
|---|---|
|
Examine the variation of cognitive function at various time-points in stage I-III breast cancer patients who have undergone or are undergoing adjuvant systemic therapy
|
To examine the variation of cognitive function at various time-points in stage I-III breast cancer patients who have undergone or are undergoing adjuvant systemic therapy (chemotherapy and/or anti-hormonal therapy) and compare this to a group of healthy controls to evaluate if there is a difference.
|
Mesures de résultats secondaires
Mesure des résultats |
|---|
|
Determine which cognitive domains in particular are affected
|
|
Assess certain other measures such as anxiety, depression, fatigue or menopausal symptoms which may have an impact on cognitive function using a set of validated questionnaires
|
|
Compare self-perceived cognitive deficits with objective measurements
|
|
Evaluate underlying biological pathways and susceptibility to cognitive dysfunction through blood biomarker studies, genetic polymorphisms and other mechanisms which we deem to be relevant
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- Bhoo-Pathy N, Hartman M, Yip CH, Saxena N, Taib NA, Lim SE, Iau P, Adami HO, Bulgiba AM, Lee SC, Verkooijen HM. Ethnic differences in survival after breast cancer in South East Asia. PLoS One. 2012;7(2):e30995. doi: 10.1371/journal.pone.0030995. Epub 2012 Feb 21.
- Polychemotherapy for early breast cancer: an overview of the randomised trials. Early Breast Cancer Trialists' Collaborative Group. Lancet. 1998 Sep 19;352(9132):930-42.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Version 01
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .