Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03775369
Other study ID # 2018-01314; ch18Cordier
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 26, 2018
Est. completion date February 28, 2022

Study information

Verified date May 2022
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To investigate the influence of two physical activity and exercising (PAE) interventions, namely resistance training and endurance training in relation to quality of life, depression, fatigue, sleep, anxiety, stress and coping, body image, and social interactions (psychological dimensions); cardiorespiratory fitness, morning cortisol secretion, inflammatory markers, and objective sleep (physiological dimensions), along with cancer-related dimensions


Description:

Patients with high grade glioma (WHO III° and IV°) and undergoing radiotherapy, chemotherapy, or both radio- and chemotherapy suffer from decreased quality of life (QoL). This study is to analyse the influence of two adjuvant interventions of physical activity and exercising (PAE) (namely resistance training and endurance training) in relation to quality of life, depression, fatigue, sleep, anxiety, stress and coping, body image, and social interactions (psychological dimensions); cardiorespiratory fitness, morning cortisol secretion, inflammatory markers, and objective sleep (physiological dimensions).


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date February 28, 2022
Est. primary completion date February 28, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Patients with high grade glioma (WHO III° and IV°), and undergoing radiotherapy, chemotherapy, or both - Willing and able to follow the study intervention - Signed written informed consent Exclusion Criteria: - Severe psychiatric (psychosis, suicidal behavior, substance use disorder) and somatic comorbidities (severe cardiovascular disease, severe diabetes, impairments of the musculo-skeletal system) - patients not willing or able anymore to follow the study protocol.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
endurance training
physical activity and exercising (PAE)
social support and counseling
social support and counseling
resistance training
physical activity and exercising (PAE)

Locations

Country Name City State
Switzerland Department of Sport, Exercise and Health, University of Basel Basel
Switzerland University Hospital Basel, Department of Neurosurgery Basel

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland University Basel, Department of Sport, Exercise and Health, Division of Sport Science and Psychosocial Health

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Functional Assessment of Cancer Therapy Scale (FACT) Cancer-related Quality of Life (QOL) assessed by Functional Assessment of Cancer Therapy Scale (FACT), a self-report instrument which measures multidimensional QOL. The FACT evaluation system uses a 29-49 item compilation of a generic core and numerous subscales (9-20 items each) which reflect symptoms associated with different diseases, symptom complexes and treatments. Baseline and week 3 and week 6
Primary Change in Hamilton Depression Rating Scale (HDRS) HDRS scale to assess patients' severity of Depression (mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms); each item on the questionnaire is scored on a 3 or 5 point scale; a score of 0-7 is considered to be normal Baseline and week 3 and week 6
Primary Change in Intolerance of Uncertainty Scale (IU) IU: 5-point rating scale (1 = not at all characteristic of me, 5 = entirely characteristic of me) indicating how much patient agrees with the item. The higher the overall score is, the more the respondent is assumed to be more intolerant of uncertainty Baseline and week 3 and week 6
Primary Change in Insomnia Severity Index (ISI) ISI is a 7-item screening measure for insomnia. Items answered on 5-point rating scales (0 = not at all, 4 = very much) Baseline and week 3 and week 6
Primary Change in Perceived Stress Scale (PSS) General perceived stress is assessed with the 10-item Perceived Stress Scale (PSS). The PSS measures the degree to which respondents find their lives unpredictable, uncontrollable and overloading. Answers were given on a five-point Likert-type scale anchored at 1 (never) to 5 (very often). Four items were reverse scored. The mean was calculated in order to obtain an overall score. Baseline and week 3 and week 6
Primary Change in Fatigue Severity Scale nine items, and answers are given on seven-point rating scales ranging from 1 (not at all) to 7 (definitively/almost always), with higher mean scores reflecting greater fatigue Baseline and week 3 and week 6
Primary Change in Mental Toughness Questionnaire (MTQ48) The 48 item MTQ48 measures the subcomponents challenge, commitment, emotional and life control, and interpersonal confidence and confidence in ability. Answers are given on five-point Likert-type scales ranging from 1 (=strongly disagree) to 5 (=strongly agree), with higher scores reflecting greater MT Baseline and week 3 and week 6
Primary Change in International Physical Activity Questionnaire questionnaire consists of several items and asks about the amount of days with walking, moderate and vigorous physical activity. Baseline and week 3 and week 6
Primary Change in submaximal 6-min walking test (6MWT) To assess functional exercise capacity, distance walked during 6 min will be assessed and compared to reference age and gender norms Baseline and week 3 and week 6
Primary Change in Grip force Maximum isometric grip force of the dominant hand is assessed using the hand dynamometer. Participants make three attempts. Mean outcomes is compared to reference data Baseline and week 3 and week 6
Secondary Change in sleep continuity assessed by EEG Sleep is objectively assessed via an easy-to-use in-home sleep-EEG. It consists of three electrodes and measures sleep continuity (awakenings after sleep onset: number of duration of awakenings) Baseline and week 6
Secondary Change in C reactive protein (CRP) (mg/l) blood samples are taken before and after the 6MWT and grip force test to assess inflammatory marker CRP (mg/l) Baseline and week 6
Secondary Change in sleep architecture (min; %) Sleep is objectively assessed via an easy-to-use in-home sleep-EEG. It consists of three electrodes and measures sleep architecture (wake, Non-rapid eye movement (REM)- sleep stages 1-4 (min; %); REM-sleep (min; %). Baseline and week 6
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05023551 - Study of DSP-0390 in Patients With Recurrent High-Grade Glioma Early Phase 1
Terminated NCT01902771 - Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors Phase 1
Active, not recruiting NCT02655601 - Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001 Phase 2
Terminated NCT03690869 - REGN2810 in Pediatric Patients With Relapsed, Refractory Solid, or Central Nervous System (CNS) Tumors and Safety and Efficacy of REGN2810 in Combination With Radiotherapy in Pediatric Patients With Newly Diagnosed or Recurrent Glioma Phase 1/Phase 2
Completed NCT01466686 - Low Dose Radiation Therapy for Glioblastoma Multiforme Phase 2
Recruiting NCT05925218 - Circulating Tumor DNA Collection From Patients With High Grade Gliomas
Recruiting NCT05212272 - MRI in High-Grade Glioma Patients Undergoing Chemoradiation
Active, not recruiting NCT04911621 - Adjuvant Dendritic Cell Immunotherapy for Pediatric Patients With High-grade Glioma or Diffuse Intrinsic Pontine Glioma Phase 1/Phase 2
Not yet recruiting NCT06333899 - Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion Early Phase 1
Recruiting NCT04734444 - SonoClear Acoustic Coupling Fluid (ACF) Mimicking Brain Tissue N/A
Completed NCT02022644 - Study of Convection-Enhanced, Image-Assisted Delivery of Liposomal-Irinotecan In Recurrent High Grade Glioma Phase 1
Completed NCT00780819 - Borderzone Sampling N/A
Recruiting NCT06072586 - Study of BDTX-1535 in Recurrent High-Grade Glioma (HGG) Participants With EGFR Alterations or Fusions Early Phase 1
Completed NCT01390948 - A Study of Bevacizumab (Avastin) in Combination With Temozolomide (TMZ) and Radiotherapy in Paediatric and Adolescent Participants With High-Grade Glioma Phase 2
Recruiting NCT03952598 - Studying the Biology of IDH-mutant Gliomas Via Longitudinal Observation of 2-hydroxyglutarate (2-HG) Using MR Spectroscopy N/A
Recruiting NCT05630664 - Liquid Biopsy in High-grade Gliomas and Meningiomas
Recruiting NCT05298995 - GD2-CAR T Cells for Pediatric Brain Tumours Phase 1
Completed NCT01222754 - Lenalidomide and Radiation Therapy in High Grade Gliomas or Diffuse Intrinsic Pontine Gliomas Phase 1
Recruiting NCT05278208 - Lutathera for Treatment of Recurrent or Progressive High-Grade CNS Tumors Phase 1/Phase 2
Completed NCT03355794 - A Study of Ribociclib and Everolimus Following Radiation Therapy in Children With Newly Diagnosed Non-biopsied Diffuse Pontine Gliomas (DIPG) and RB+ Biopsied DIPG and High Grade Gliomas (HGG) Phase 1