About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Exercise Prehabilitation
Behavioral
The prehabilitation group will be asked to undertake a remote exercise programme. The home-based exercise sessions will take place four times per week. Two will be unsupervised exercise sessions, and the other two will be online supervised exercise sessions. Each session will last for approximately 40 minutes for a minimum of 3 weeks, a maximum of 4 weeks. Exercise tolerance will be built up from 2 supervised sessions (week 1) up to the recommended four sessions per week (week 3/4). The number of sessions will be sustained throughout chemotherapy until the end of chemotherapy (visit 3). The participants will be remotely supervised by a qualified exercise instructor. They will have a combination of aerobic and resistance exercise within each session. It will be individualised and tailored to their physical abilities. The exercises will target their upper body (arms and shoulders) and legs. Exercise programmes, videos, and links to supervised sessions will be provided.
Multivitamins
Dietary supplement
Multivitamins will be given following the first testing visit until the third visit (following the last chemotherapy round). The multivitamins will be taken daily before and during chemotherapy. The multivitamin supplement contains a combination of 24 essential vitamins (vitamin A, D2, B1, B2, B6, B12, C, E, Biotin, nicotinamide, pantothenic acid and folic acid), minerals and trace elements (calcium, iron, copper, phosphorus, magnesium, potassium, zinc, iodine, manganese, selenium, chromium, and molybdenum). Each multivitamin and mineral plays a vital role in the efficient daily maintenance of many body processes.
Standard Care (in control arm)
Other intervention
Participants with colorectal cancer will receive chemotherapy treatment.

Treatment groups

86 Participants

are divided into 2 treatment groups

Group A: Prehabilitation groupExperimental treatment 3 interventions

Group B: Standard Care GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

Blood-based markers

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).

Time frame

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).

2

Change in brain activity during the Flanker Inhibitory Control and Attention Test

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.

Time frame

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).

3

Change in brain activity during the List Sorting Working Memory Test

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.

Time frame

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).

4

Change in brain activity during the Oral Symbol Digit Test

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.

Time frame

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).

Secondary outcomes

1

Change in Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) total score

The Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) is a self-report questionnaire designed to evaluate how cancer patients perceive their cognitive difficulties, such as memory or concentration issues, and the impact these have on their daily lives and quality of life. The instrument comprises 37 items, each rated on a 5-point Likert scale, yielding a total score ranging from 0 to 148, where higher scores reflect better perceived cognitive functioning and fewer cognitive difficulties. The total FACT-Cog score will be used as the outcome measure to assess change in perceived cognitive function between baseline (before chemotherapy) and three months following the last round of chemotherapy.

Time frame

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.

Chemo Brain Prehab Project

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts