Chemo Brain Prehab Project: Improving Brain Health After Chemotherapy Through Prehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 86
- 试验地点
- 7
- 主要终点
- Blood-based markers
研究概览
简要总结
Colorectal cancer is 37% higher in the North West than the national average and is treated by chemotherapy, including fluorouracil, capecitabine, and oxaliplatin. A side effect of these drugs is loss of memory, forgetfulness, and general brain fog, which can persist for months after the end of treatment. These symptoms are collectively known as 'chemo-brain'. An existing prehabilitation intervention that has been previously developed will be used, which increases fitness and reduces hospital length of stay in colorectal cancer surgery patients, to try to improve the symptoms of chemo-brain in those undergoing chemotherapy and improve quality of life.
详细描述
Colorectal cancer rates in the North West are 37% higher than the national average, with the lowest overall survival in England at 58.1%. Standard chemotherapy drugs such as fluorouracil, capecitabine, and oxaliplatin effectively treat tumours but can damage healthy cells, leading to side effects. One common and distressing effect is known as "chemo-brain", which involves problems with memory, attention, and thinking speed. These symptoms can reduce quality of life and increase stress.
Prehabilitation, which involves exercise and nutritional support before treatment, has demonstrated significant benefits in the surgical setting by improving cardiorespiratory fitness, physical function, and recovery. However, its role before chemotherapy is less clear. Exercise promotes both physical and brain health by increasing growth factors, improving blood flow to the brain, and supporting the formation of new brain cells and blood vessels.
This study aims to investigate whether an exercise-based prehabilitation programme can reduce the symptoms of chemo-brain, improve brain health and enhance quality of life in older adults undergoing chemotherapy for colorectal cancer. Participants aged 60-85 years with stage II or III colorectal cancer scheduled to receive chemotherapy (fluorouracil, capecitabine, or oxaliplatin) are eligible. Suitability to receive chemotherapy must be confirmed by the clinical care team via medical records.
Participants will take part in a remotely supervised exercise programme before and during chemotherapy. The programme consists of four 40-minute sessions per week, including two supervised sessions delivered via video by the lead investigator and two independent sessions supported by an exercise booklet and videos.
Each session includes a warm-up, 20 minutes of aerobic exercise at around 60% of peak fitness, strengthening exercises for upper and lower limbs using resistance bands, and a cool-down. Exercises will be adjusted based on individual ability, with progressions and regressions provided. Participants must have a family member, carer, or friend present during supervised sessions for safety. Psychological support and multivitamin supplementation will also be included.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with stage II or III colorectal cancer undergoing chemotherapy with fluorouracil, capecitabine, or oxaliplatin.
- •Aged 60-85 years old.
- •Fluent in English
- •Male and female participants
- •Not engaged in structured exercise training* within the six months before providing consent.
排除标准
- •Presence of comorbidities that may significantly alter the metabolic response to exercise (e.g., diabetes mellitus).
- •Any contraindication to the multivitamin supplementation (Forceval), including known hypercalcaemia, haemochromatosis, peanut or soya allergy, current use of phenytoin or tetracycline antibiotics, and clinically significant impaired renal or hepatic function.
- •Evidence of pre-existing cognitive impairment, including diagnosis of dementia, other neurodegenerative disorders (e.g., Alzheimer's disease), or clinically indicated mild cognitive impairment.
- •Diagnosis of atrial fibrillation and haematological malignancy.
- •Participants without home internet access will be excluded due to the online delivery of the exercise programme.
- •Diagnosis of profound hearing loss.
- •Receiving palliative care.
- •Presence of synchronous cancer.
- •Structured exercise refers to planned and organised physical activity, such as gym workouts, exercise classes or a team sport, which are designed to improve or maintain physical fitness, often with instruction, rules, and goals.
研究组 & 干预措施
Prehabilitation group
This group will receive the exercise programme before and during chemotherapy (4 times per week; 2 supervised online home-based sessions and 2 unsupervised home-based sessions), with the addition of daily multivitamins and behavioural support via a weekly telephone check-up.
干预措施: Exercise Prehabilitation (Behavioral)
Prehabilitation group
This group will receive the exercise programme before and during chemotherapy (4 times per week; 2 supervised online home-based sessions and 2 unsupervised home-based sessions), with the addition of daily multivitamins and behavioural support via a weekly telephone check-up.
干预措施: Multivitamins (Dietary Supplement)
Prehabilitation group
This group will receive the exercise programme before and during chemotherapy (4 times per week; 2 supervised online home-based sessions and 2 unsupervised home-based sessions), with the addition of daily multivitamins and behavioural support via a weekly telephone check-up.
干预措施: Standard Care (in control arm) (Other)
Standard Care Group
This group will receive their treatment as planned as part of standard care, but will not receive the prehabilitation (exercise, nutrition, and behavioural support).
干预措施: Standard Care (in control arm) (Other)
结局指标
主要结局
Blood-based markers
时间窗: Blood-based markers will be collected at three visits: baseline (visit 1), 72 hours before the start of chemotherapy (visit 2) and 72 hours after the final dose of chemotherapy has been received (visit 3).
Use physiological blood-based markers to establish if prehabilitation promotes an improvement in brain health in colorectal cancer patients before starting chemotherapy. Brain-Derived Neurotrophic Factor (BDNF) and Vascular Endothelial Growth Factor (VEGF).
Change in brain activity during the Flanker Inhibitory Control and Attention Test
时间窗: Data from the Flanker Inhibitory Control and Attention Test will be collected at three visits: baseline (visit 1), 72 hours before the start of chemotherapy (visit 2) and 72 hours after the final dose of chemotherapy has been received (visit 3).
Cognitive function and its neural correlates will be assessed while participants complete the NIH Toolbox Flanker Inhibitory Control and Attention Test during electroencephalography (EEG) recording. This test assesses inhibitory control and attention by requiring participants to focus on a central target (fish or arrows) and identify its direction while ignoring distracting "flanker" stimuli pointing in a different direction, using a scoring algorithm combining accuracy and reaction time for a cognitive score. Flanker raw scores (0-10) will be converted to age-corrected standard scores (mean 100, standard deviation (SD) 15), with higher scores indicating better cognitive performance. Age-standardised Flanker scores and task-related EEG measures (spectral power ratios and event-related potentials) will be compared across visits 1-3 within participants and between intervention and control groups to examine changes in cognitive performance and associated brain activity.
Change in brain activity during the List Sorting Working Memory Test
时间窗: Data from the List Sorting Working Memory Test will be collected at three visits: baseline (visit 1), 72 hours before the start of chemotherapy (visit 2) and 72 hours after the final dose of chemotherapy has been received (visit 3).
Cognitive function and its neural correlates will be assessed while participants complete the NIH Toolbox List Sorting Working Memory Test during electroencephalography (EEG) recording. The test assesses working memory by having individuals recall and sequence visually presented items (such as food and animal pictures) in order of size (smallest to largest) after they disappear. Performance is based on correctly sequenced items. The list sorting raw scores (0-10) will be converted to age-corrected standard scores (mean 100, standard deviation (SD) 15), with higher scores indicating better cognitive performance. Age-standardised list sorting scores and task-related EEG measures (spectral power ratios and event-related potentials) will be compared across visits 1-3 within participants and between intervention and control groups to examine changes in cognitive performance and associated brain activity.
Change in brain activity during the Oral Symbol Digit Test
时间窗: Data from the Oral Symbol Digit Test will be collected at three visits: baseline (visit 1), 72 hours before the start of chemotherapy (visit 2) and 72 hours after the final dose of chemotherapy has been received (visit 3).
Cognitive function and its neural correlates will be assessed while participants complete the NIH Toolbox Oral Symbol Digit Test during electroencephalography (EEG) recording. This test is a brief, computerised measure of processing speed, where participants orally match symbols to numbers from a key (1-9) presented on an iPad for 120 seconds, scoring how many correct matches they make sequentially to assess rapid visual information processing. The oral symbol digit raw scores (0-10) will be converted to age-corrected standard scores (mean 100, standard deviation (SD) 15), with higher scores indicating better cognitive performance. Age-standardised oral symbol digit test scores and task-related EEG measures (spectral power ratios and event-related potentials) will be compared across visits 1-3 within participants and between intervention and control groups to examine changes in cognitive performance and associated brain activity.
Changes in brain activity during the Words-In-Noise Test
时间窗: Data from the Words-In-Noise Test will be collected at three visits: baseline (visit 1), 72 hours before the start of chemotherapy (visit 2) and 72 hours after the final dose of chemotherapy has been received (visit 3).
Audition and its neural correlates will be assessed while participants complete the NIH Toolbox Words-In-Noise Test during electroencephalography (EEG) recording. The test assesses a person's ability to understand spoken words amidst varying levels of background noise. The test is scored by determining the signal-to-noise ratio (SNR) at which a person correctly repeats 50% of the words, called the SNR50, calculated using the Spearman-Kärber equation. Lower SNR50 values (in dB) indicate better hearing in noise, and higher SNR50 values indicate poorer performance. Participants will be classified as having adequate hearing in noise if their SNR50 is ≤ 6 dB. The SNR50 and task-related EEG measures (spectral power ratios and event-related potentials) will be compared across visits 1-3 within participants and between intervention and control groups to examine changes in cognitive performance and associated brain activity.
次要结局
- Change in Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) total score(The cognitive-related quality of life scores (FACT-Cog) will be collected at three visits: baseline (visit 1) and three months following the final round of chemotherapy.)
研究者
Dr. Chris Gaffney
Senior Lecturer in Integrative Physiology
Lancaster University