Interdisciplinary Rehabilitation of Patients With Glioma During Anti-cancer Treatment

Neoplasms Clinical Trial

Official title:

Interdisciplinary Rehabilitation of Patients With Glioma During Anti-cancer Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02221986
• Other study ID #: S-20140108
• Status: Completed
• Phase: N/A
• First received: August 19, 2014
• Last updated: April 3, 2018
• Start date: February 1, 2015
• Est. completion date: February 14, 2018

Study information

• Verified date: September 2017
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The results of the present RCT study will add to the growing body of literature investigating the potential role of exercise as a supportive therapeutic intervention for patient with glioma.

Description:

Gliomas are the most frequent primary neoplasm in the CNS and according to the World Health Organization histologically categorized into low-grade glioma (LGG) (WHO grades I/II) or high-grade glioma (HGG) (WHO grades III/IV). Gliomas are among the biggest challenges within the field of neuro-rehabilitation and oncology, and optimising treatment by improving QoL, function and cognition is of major clinical importance in this population. Because the majority of patients cannot be cured, clinical cancer research traditionally have focused on prolonging survival, exposing relapse or optimising the response to the medical treatment. Today there is a general consensus that health-related quality of life (HRQoL) is important in the evaluation of new treatments. However, research in HRQoL among patients with gliomas is scarce compared to the other categories of patients with tumors. In recent years have exercise become an important part of cancer treatment. The effects is well documented in studies among other cancer patients than gliomas and includes improvements of quality of life, physical function, reduce fatigue and thereby supports daily activities among cancer patients'. Inpatient rehabilitation studies among glioma patients have also indicated improved HRQoL and functional measurements such as activity of daily life, mobility and cognition. Despite of this rehabilitation efforts is still not emphasized in this population and recent literature concludes that there are no well-designed clinical studies examining the effect of multidisciplinary rehabilitation among Glioma patients. This study is the first to investigate the effect of an intensive specialised interdisciplinary outpatient rehabilitation program among gliomas patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: February 14, 2018
• Est. primary completion date: February 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of primary glioma (WHO grades I-IV)

• Age = 18

• Reference with diagnosis or treatment at Odense University Hospital

• Karnofsky performance score (KPS) =70

• Ability to understand Danish.

Exclusion Criteria:

• Pregnancy

• Known psychiatric diagnosis or substance abuse

• Heart problems excluding intense exercise (NYHA group III and IV)

• Pronounced impressive/expressive aphasia

Related Conditions & MeSH terms

• CNS Neoplasms
• Glioma
• Neoplasms

Intervention

Behavioral:
• Interdisciplinary rehabilitation

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense	Funen

Sponsors (2)

Lead Sponsor	Collaborator
Odense University Hospital	University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health related quality of life	Questionnaires EORTC-QLQ-30 & BN-20	Change from Baseline HRQoL at 6 months
Secondary	Symptom burden	Assessed through EORTC-QLQ-30 & BN-20	Change from Baseline Symptom burden at 6 months
Secondary	Physical activity levels	Physical activity at work and leisure time ( Assessed through questionnaire by Saltin and Grimsby 1968 and Physical Activity Scale)	Change from Baseline Physical activity levels at 6 months
Secondary	Muscle strength	Assessed through 3-8 submax repetition maximum	Change from Baseline Musclestrength at 3 months
Secondary	VO2peak	Assessed through Åstrand 1-pkt. cycle test.	Change from Baseline VO2peak at 3 months
Secondary	Balance	Assessed through wii balance board	Change from Baseline Balance at 3 months
Secondary	Gait function	Assessed through 10 meter walk test. Time and step frequency.	Change from Baseline gait function at 3 months
Secondary	Activity levels	Assessed through questionnaire (Impact on Participation and Autonomy)	Change from Baseline Activity levels at 3 months