Status:
COMPLETED
Validation of Readiband™ Actigraph and Associated Sleep/Wake Classification Algorithms
Lead Sponsor:
Allina Health System
Conditions:
Glioma
Glioblastoma
Eligibility:
All Genders
22-70 years
Brief Summary
This pilot study will assess feasibility and to obtain initial estimates of efficacy of Sleep Activity and Task Effectiveness (SAFTE) model, which can accurately estimate the impact of scheduling fact...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- i. Patients aged between 22 and 70. ii. Patients must have a histologic diagnosis of primary Grade IV glioma. iii. Patients must have received maximal debulking surgery and radiotherapy concomitant with Temozolomide (≥ 75% of their recommended temozolomide dosage is required).
- iv. Patients with KPS ≥70. v. Life expectancy at least 3 months. vi. Patients must have signed informed consent for study participation. vii. Patients should be English speakers.
- Exclusion Criteria
- i. Patients enrolled in active clinical treatment trials for primary Grade IV glioma.
- ii. Patients with progressive disease after completion of radiotherapy concomitant with Temozolomide as per RANO criteria. Suspected pseudoprogression should be confirmed by additional imaging studies ordered as part of standard care.
- iii. Patients with known other active malignancy diagnosed in the past 3 years (except for in situ malignancies).
- iv. Patients who are pregnant or trying to get pregnant. v. Patients unable to wear the ReadiBand device continuously during study duration.
- vi. Patients with infra-tentorial tumors. vii. Patients with known psychiatric concerns. viii. Significant co-morbidities at baseline which would prevent maintenance Temozolomide treatment:
- Thrombocytopenia (platelet count \< 100 x 103/μL)
- Neutropenia (absolute neutrophil count \< 1.5 x 103/μL)
- CTC grade 4 non-hematological Toxicity (except for alopecia, nausea, vomiting)
- Significant liver function impairment - AST or ALT \> 3 times the upper limit of normal
- Total bilirubin \> upper limit of normal, if clinically significant
- Significant renal impairment (serum creatinine \> 1.7 mg/dL)
Exclusion
Key Trial Info
Start Date :
March 15 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2021
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03877861
Start Date
March 15 2018
End Date
May 1 2021
Last Update
June 9 2021
Active Locations (1)
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1
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407