Neoplasms Clinical Trial
— TOGETHEROfficial title:
Stress, Exercise Behavior and Survival in Patients With Newly Diagnosed Glioblastoma and in a Close Partner (TOGETHER-study): a Prospective Multicenter Cohort Study.
Verified date | May 2017 |
Source | University Hospital, Basel, Switzerland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Glioblastoma multiforme (GBM) is the most common malignant central nervous system (CNS)
tumor in adulthood with a median survival of 12-16 months. The drastically shorted life
expectancy, intellectual changes and rapid physical decline in those patients are
devastating and do impose a profound chronic stress on patients and their families. There is
extensive evidence that chronic stress can promote cancer growth and progression. In the
setting of GBM patients, three major questions still have to be answered and will be
analysed in this study:
1. Is there a prognostic significance of stress in patients with newly diagnosed GBM on
treatment tolerance and (progression free) survival?
2. Can this stress be modulated by other factors, like stress of patients partners and
patients physical activity, a known independent prognostic factor in recurrent glioma
patients?
3. How is the longitudinal course of patients and partners stress and physical condition
over the disease course and do they influence (progression free) survival?
Answers to these questions will help to establish future projects studying non drug
interventions in patients and patients partners to help improving clinical and tumor related
outcome in patients with newly diagnosed GBM.
The investigators hypothesize that chronic stress, specifically measured as a disruption of
the diurnal cortisol rhythmicity, is an independent prognostic factor in patients with GBM.
Furthermore, physical activity of patients and stress level in patients` partners may impact
- as stress-modulating factors- on stress in patients and on their prognosis.
Aiming at identifying stress-related prognostic factors as potential targets for novel
treatment approaches, we propose, in a first step, a prospective multicenter cohort study:
all patients with newly diagnosed GBM and good performance status (KPS ≥ 50%) who undergo
standard treatment with combined radiochemotherapy with temozolomide (RCT) followed by 6
month of cyclic temozolomide, are eligible. In addition, one "partner", defined as a close
person living in the same home or close daily contact to the patient, will be asked for
inclusion.
Status | Terminated |
Enrollment | 12 |
Est. completion date | May 2017 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Patients: - age =18 years - Karnofsky Performance Score = 50 % - histologically confirmed, previously untreated GBM - radiochemotherapy according to Stupp et al [1] is planned (ideally, treatment start can be scheduled on a Monday) - no cardiovascular or neurological contraindications for 6MWT and/or a history of instable angina pectoris or NYHA grade II or greater congestive heart failure (according to the Thoracic Society recommendations [2]) - willing and able to comply with the protocol as judged by the investigator - signed informed consent Partners: - age =18 years - willing and able to comply with the protocol as judged by the investigator - spouse or partner living in the same home as the patient or closest contact as named by the patient (1-2h 5 days a week) - signed informed consent Exclusion Criteria: Patients: - Patients who have any other disease, either metabolic or psychological, or who have any evidence on clinical examination or special investigations (including laboratory findings) which give reasonable suspicion of a condition that interferes with the adequate measurement of the stress axis (e.g. chronic use of corticosteroids = 3 months before study entry for disease other than glioblastoma, (dexamethasone use in the context of glioblastoma is allowed) - Severe, medically treated psychiatric disorder prior to the diagnosis of glioblastoma - Participation in a study with investigational drugs - Severe asthma or known allergy against tetracosactide (Synacthen®) - Pregnancy or breast feeding - Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurologic deficits that interfere with the planned walking tests, dementia or confusional state Partners: - Individuals who have any disease, either metabolic or psychological, that interferes with the adequate measurement of the stress axis (e.g. chronic use of corticosteroids (= 3 months), psychiatric disorders) - Pregnancy or breast feeding - Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia or confusional state |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Basel | Basel | |
Switzerland | Kantonsspital Luzern | Luzern | |
Switzerland | University Hospital Neurology | Zürich |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Basel, Switzerland | Luzerner Kantonsspital, University Hospital Inselspital, Berne, University Hospital, Zürich |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression free survival | analysis | 12 month | |
Secondary | Overall survival | analysis | 12 month |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03826043 -
THrombo-Embolic Event in Onco-hematology
|
N/A | |
Terminated |
NCT03166631 -
A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread
|
Phase 1 | |
Completed |
NCT01938846 -
BI 860585 Dose Escalation Single Agent and in Combination With Exemestane or With Paclitaxel in Patients With Various Advanced and/or Metastatic Solid Tumors
|
Phase 1 | |
Recruiting |
NCT06058312 -
Individual Food Preferences for the Mediterranean Diet in Cancer Patients
|
N/A | |
Completed |
NCT03308942 -
Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants
|
Phase 2 | |
Recruiting |
NCT06018311 -
Exercising Together for Hispanic Prostate Cancer Survivor-Caregiver Dyads
|
N/A | |
Withdrawn |
NCT05431439 -
Omics of Cancer: OncoGenomics
|
||
Completed |
NCT01343043 -
A Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO-1ᶜ²⁵⁹T in HLA-A2+ Patients With Synovial Sarcoma
|
Phase 1 | |
Completed |
NCT01938638 -
Open Label Phase I Dose Escalation Study With BAY1143572 in Patients With Advanced Cancer
|
Phase 1 | |
Recruiting |
NCT05514444 -
Study of MK-4464 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors (MK-4464-001)
|
Phase 1 | |
Recruiting |
NCT02292641 -
Beyond TME Origins
|
N/A | |
Terminated |
NCT00954512 -
Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Participants With Advanced Solid Tumors (P04722, MK-7454-004)
|
Phase 1/Phase 2 | |
Recruiting |
NCT04958239 -
A Study to Test Different Doses of BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors)
|
Phase 1 | |
Recruiting |
NCT04627376 -
Multimodal Program for Cancer Related Cachexia Prevention
|
N/A | |
Completed |
NCT01222728 -
Using Positron Emission Tomography to Predict Intracranial Tumor Growth in Neurofibromatosis Type II Patients
|
||
Recruiting |
NCT06004440 -
Real World Registry for Use of the Ion Endoluminal System
|
||
Active, not recruiting |
NCT05636696 -
COMPANION: A Couple Intervention Targeting Cancer-related Fatigue
|
N/A | |
Not yet recruiting |
NCT06035549 -
Resilience in East Asian Immigrants for Advance Care Planning Discussions
|
N/A | |
Recruiting |
NCT06004466 -
Noninvasive Internal Jugular Venous Oximetry
|
||
Completed |
NCT02909348 -
Immunophenotyping of Melanoma Patients on Treatment With Pembrolizumab
|