Long Term Implications of Rare Brain Tumours'

Quality of Life Clinical Trial

Official title:

Understanding the Long-term Implications of Treatment of Rare Brain Tumours on Health-related Quality of Life: A European Cross-sectional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04708548
• Other study ID #: 279885
• Status: Completed
• Start date: May 29, 2020
• Est. completion date: February 28, 2023

Study information

• Verified date: May 2023
• Source: University of Leeds
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patients diagnosed with oligodendroglioma with a specific molecular profile represent rare tumour groups (about 10% of adult gliomas) with relatively favourable prognosis (median survival between 8 and 12 years). These patients are often treated with surgery, chemotherapy and/or radiotherapy. However, as patients live for a long period of time, they may also experience long-term toxic side-effects of treatment. The long-term consequences of treatment- and disease-related factors on quality of life and cognitive functioning of these patients are largely unknown. This study aims to investigate quality of life and cognitive functioning in long-term survivors of oligodendroglioma (with IDH mutation and 1p/19q codeletion). This knowledge can support health care professionals prepare patients for any long-term consequences of treatment.

Description:

The WHO classification of primary brain tumours has recently been updated and now also takes molecular parameters into account to provide clinicians with more accurate information on the expected disease course and to guide treatment decisions.1 Patients with oligodendrogliomas of WHO grades II or grade III (OII and OIII) defined by IDH mutation and 1p/19q co-deletion represent rare tumour groups (~10% of adult gliomas) with relatively favourable prognosis (median survival 11.9 years for OII and 8.5 years for OIII).2 However, this disease remains life-threatening as over time, all tumours are likely to progress with a more malignant phenotype. Recent changes in the management of these patients followed after the publication of long-term follow-up data from two landmark studies on OIII carried out by EORTC and RTOG in the 1990s,3, 4 and a RTOG study on low-grade glioma including OII.5 These data suggest that standard treatment should comprise surgical resection of the tumour as feasible followed by radiotherapy and chemotherapy. These studies used radiotherapy doses of 54-60 Gy and PCV (procarbazine, CCNU, vincristine) polychemotherapy. Among high-risk WHO grade II glioma patients, including OII, postoperative temozolomide chemotherapy was not superior in terms of progression-free survival or health-related quality of life (HRQOL) compared to postoperative radiotherapy.6,7 The discussion on whether temozolomide or PCV would be the better chemotherapy in these two patient groups is still ongoing. With patients surviving longer whilst receiving more treatments that may have long-term toxic side-effects, additional questions are raised regarding the effects on HRQOL and cognitive functioning of patients. Indeed, investigating the long-term effects of treatment is listed as a top priority in neuro-oncology research. 8 Preliminary research The investigational team has almost three decades of research experience in the area of HRQOL and cognitive deficits after glioma treatment. Previous research has found that patients with both low- and high-grade gliomas can experience compromised HRQOL and cognitive functioning, which was generally more pronounced in the high-grade glioma group. However in those with stable, low-grade glioma, HRQOL and cognitive deficits were highly correlated, supporting the notion that even subtle cognitive deficits can affect autonomy in long-term glioma survivors. While short-term negative effects of chemotherapy on HRQOL are well-documented, longer-term effects of antineoplastic drugs (e.g., bevacizumab) are unknown. Moreover, even low fraction doses of radiotherapy have been shown to have negative consequences for patients' cognitive functioning. WHO grade I and II glioma survivors were assessed on average 12 years after diagnosis and while cognitive functioning had remained stable in patients who had not been treated with radiotherapy, even those who received presumed safe doses (

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed oligodendroglioma WHO grade II or III with IDH mutation and 1p/19q co-deletion
• Diagnosis must have been =5 years ago
• Patient is =18 years of age
• Willing and able to provide written informed consent

Exclusion Criteria:

• They are expected to be unable to complete consent procedures and/or study outcomes due to legal incompetence or insufficient mastery of the language of the country in which they live as determined by their treating physician.
• They do not provide written informed consent

Related Conditions & MeSH terms

• Cognitive Impairment
• Health-related Quality of Life
• Long-term Effects of Cancer Treatment
• Neoplasms
• Oligodendroglioma
• Quality of Life
• WHO Grade II Oligodendroglial Tumor
• WHO Grade III Oligodendroglial Tumor

Intervention

Other:
• Health-related Quality of Life
Health-related quality of life (HRQOL) is an individual's or a group's perceived physical and mental health over time.
• Psychological Distress
Measured of the distress experienced by patients
• Fatigue
Measure of the extreme tiredness resulting from mental or physical exertion or illness
• Cognitive Functioning
Cognitive functioning refers to multiple mental abilities, including learning, thinking, reasoning, remembering, problem solving, decision making, and attention. This will be measured through self-report and cognitive testing.

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC	Amsterdam	North Hollan
United Kingdom	Leeds Institute of Medical Research	Leeds	West Yorkshire

Sponsors (3)

Lead Sponsor	Collaborator
Galina Velikova	European Organisation for Research and Treatment of Cancer - EORTC, The Leeds Teaching Hospitals NHS Trust

Countries where clinical trial is conducted

Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health Related Quality of Life - EORTC QLQ-C30	To assess the effects of an Oligodendroglioma diagnosis on health related quality of life, The EORTC QLQ-C30 assesses functioning domains (e.g. physical, emotional, role) and common cancer symptoms (e.g. fatigue, pain, nausea/vomiting, appetite loss - the higher the score of each item, the greater the intensity/frequency of the experience e.g., 'Have you had pain?' (1 = not at all, 2 = a little , 3 = quite a bit, 4 = very much)	through study completion, an average of 1 year
Primary	Disease Specific Quality of Life - EORTC QLQ-BN20	To assess the disease specific quality of life of brain tumour patients. The EORTC QLQ-BN20 consists of 20 items that assess future uncertainty, visual disorder, motor dysfunction, and communication deficit. The higher the score of each item, the greater the intensity/frequency of the experience e.g., 'Did you have difficulty speaking?' (1 = not at all, 2 = a little , 3 = quite a bit, 4 = very much)	through study completion, an average of 1 year
Secondary	Psychological Distress - Hospital Anxiety and Distress Scale (HADS)	To measure the psychological distress felt by patients, the HADS is is a 14-item measure designed to assess anxiety and depression symptoms in medical patients, with emphasis on reducing the impact of physical illness on the total score - e.g.- 'I feel tense or 'wound up' (Most of the time, A lot of the time, Time to time, Not at all).	through study completion, an average of 1 year
Secondary	Fatigue - Multidimensional Fatigue Inventory (MFI)	To assess the level of fatigue experienced by patients, the Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. - E.G. 'I feel fit' (Yes that is true - No, that is not true (scale going from 1-5, 1 being true, 5 being not true.)	through study completion, an average of 1 year
Secondary	Hopkins Verbal Learning Test - Recall	The HVLT-R is a learning test, which consists of 12 words within three semantic groups. The test consists of three acquisition trials in which the administrator reads the words aloud and then asks the participant to repeat as many as they can remember. A delayed recall trial is introduced after 20 min, in which the participant is asked to simply retrieve as many of the words listed in the acquisition trial as he/she can remember. Lower raw scores indicate difficulties with word learning and recall, thus suggesting cognitive impairment.	through study completion, an average of 1 year

External Links

•   Research group website/webpage relating to the study