NCT03736460

Cancer Related Cognitive Impairment After Chemotherapy: Evaluation of Potential Therapeutic Interventions

Status unknown NA Last updated 22 April 2020

What this trial tests

NA trial testing Mindfulness in Cognitive Impairment in 120 participants. Status unknown.

Timeline

1 October 2018

Primary endpoint
1 March 2021

30 September 2021

Quick facts

Lead sponsor	KU Leuven
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	120
Start date	1 October 2018
Primary completion	1 March 2021
Estimated completion	30 September 2021
Sites	1 location across Belgium

Drugs / interventions tested

• Mindfulness
• Physical training

Conditions studied

• Cognitive Impairment — all drugs for Cognitive Impairment →

Sponsor

KU Leuven — full company profile →

Who can join

Adults 18 to 65, female only, with Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Mindfulness has been applied to improve after cancer care by enhancing psychological well-being; however, little is known about its impact on cognitive impairment experienced by cancer patients after chemotherapy. Mindfulness may be relevant in tackling cognitive impairment by decreasing emotional distress and fatigue, by decreasing inflammation, and by strengthening brain functional connectivity. The aim of the present study protocol is to evaluate the efficacy and mechanisms of a mindfulness-based intervention to reduce cognitive impairment in breast-cancer patients after chemotherapy.

Methods: The present study is a three-group randomized controlled trial with assessments at baseline, one-three weeks after the intervention and at three months follow-up. One hundred twenty breast cancer patients who ended treatment minimum 6 months and maximum 5 years before and who have cognitive complaints will be enrolled. They will be randomized into one of the following three study arms: (1) a mindfulness-based intervention group (n=40), (2) an active control condition based on physical training (n=40), or (3) a waitlist control group (n=40). Both the mindfulness-based intervention and the active control condition exist of four group sessions (3 hours for the mindfulness condition and 2 hours for the physical training) spread over 8 weeks. The primary outcomes will be cognitive complaints as measured by the cognitive failure questionnaire and changes in brain functional connectivity in the attention network. Secondary outcomes will be (1) levels of emotional distress, fatigue, mindfulness; (2) neurocognitive tests; (3) structural and functional brain changes using MR imaging, and (4) inflammation.

Discussion: The study will examine the impact of a mindfulness-based intervention on cognitive impairment in breast-cancer patients. If the findings of this study confirm the effectiveness of a mindfulness-based program to reduce cognitive impairment, it will be possible to improve quality of life for ex-cancer patients. We will inform health care providers about the potential use of a mindfulness-based intervention as a non-pharmaceutical, low-threshold mental health intervention to improve cognitive impairment after cancer.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. A mindfulness-based intervention for breast cancer patients with cognitive impairment after chemotherapy: study protocol of a three-group randomized controlled trial.
   Van der Gucht K, Melis M, Ahmadoun S, Gebruers A, et al · · 2020 · cited 11× · PMID 32293533 · DOI 10.1186/s13063-020-4204-8
2. The Impact of Mindfulness on Functional Brain Connectivity and Peripheral Inflammation in Breast Cancer Survivors with Cognitive Complaints.
   Melis M, Schroyen G, Blommaert J, Leenaerts N, et al · · 2023 · cited 5× · PMID 37509292 · DOI 10.3390/cancers15143632
3. The impact of mindfulness on working memory-related brain activation in breast cancer survivors with cognitive complaints.
   Melis M, Blommaert J, Van der Gucht K, Smeets A, et al · · 2025 · cited 3× · PMID 37922071 · DOI 10.1007/s11764-023-01484-0
4. A mindfulness-based intervention for breast cancer patients with cognitive impairment after chemotherapy: Study protocol of a three–group randomized controlled trial
   Gucht KVd, Melis M, Ahmadoun S, Gebruers A, et al · · 2020 · DOI 10.21203/rs.2.315/v3