Colorectal CancerCHEMOBRAINNCT07341217
Chemo Brain Prehab Project
A study testing Exercise Prehabilitation and Multivitamins in people with Colorectal Cancer and Older Adults (60 - 85 Years Old), run by Dr. Chris Gaffney at 4 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Colorectal Cancer, Older Adults (60 - 85 Years Old), Physically Inactive
- What is being tested?
- Exercise Prehabilitation and Multivitamins
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 7 Jul 2026to 16 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Christopher Gaffney, BSc (Hons.) MSc PhD FHEA contact
Katie L Hoad, BSc (Hons.) MSc PhD contact
United Kingdom4 sites, 4 recruiting
- Recruiting
East Lancashire Teaching Hospitals NHS Trust
Blackburn, Lancashire, BB2 3HH
Daren Subar, +44 (0) 1524 735 604 ext. 0044, daren.subar@elht.nhs.uk
Daren Subar
- Not yet recruiting
University Hospitals Morecambe Bay Trust, Royal Lancaster Infirmary
Lancaster, Lancashire, LA1 4RP
Chan Ton, +44 (0) 1539 732 288 ext. 0044, chan.ton@mbht.nhs.uk
Chan Ton
- Recruiting
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, L7 8YA
Jessica Hale, +44 (0) 151 556 5045, jessica.hale3@nhs.net
- Not yet recruiting
Lancashire Teaching Hospitals NHS Trust
Preston, Lancashire, PR2 9HT
Deborah Williamson, +44 (0) 1772 522 984 ext. 0044, deborah.williamson@lthtr.nhs.uk
Deborah Williamson
About this study
Official title: Chemo Brain Prehab Project: Improving Brain Health After Chemotherapy Through Prehabilitation
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.
Read the detailed description
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.
Assessments will take place at three time points:
- Visit 1 (baseline): 3-4 weeks before chemotherapy.
- Visit 2: Within 72 hours of starting chemotherapy.
- Visit 3: 3-4 days after the final chemotherapy session. A follow-up will occur three months after chemotherapy. At each assessment, functional fitness, blood samples, brain activity (EEG), cognitive tests, and quality of life questionnaires will be completed.
While there is no guarantee of direct benefit, participation may improve fitness, reduce fatigue, and enhance quality of life during chemotherapy. Exercise can also support mood, manage anxiety and depression, and potentially lessen cognitive changes linked to chemotherapy. Participants will contribute to research that could help improve future cancer care.
Risks are minimal and will be closely managed. All tests will be conducted under medical supervision with appropriate screening, warm-ups, and safety procedures in place. Exercise carries a small risk of muscle strain, but exercises will be tailored to ability.
EEG recordings are safe, though mild skin irritation may occur from the cap or cleaning solution. Blood sampling can cause minor bruising or discomfort, but it will be performed by trained professionals. Cognitive testing may occasionally cause fatigue or frustration.
All procedures will take place in hospital settings with immediate access to medical staff. Any clinical concerns identified during testing will be reported to the participant's oncology team or helpline, following consent procedures. The study will not alter or interfere with normal clinical care.
All data, including personal contact information, will be securely managed within Lancaster University's Microsoft Teams environment, ensuring full GDPR compliance. The study is run by Lancaster University in collaboration with East Lancashire Teaching Hospitals NHS Trust, Lancashire Teaching Hospital NHS Trust, and University Hospitals of Morecambe Bay NHS Trust. Recruitment and testing will take place across all participating sites.
The study is due to begin in early 2026 and will run until September 2027. This study is funded by North West Cancer Research.
- Being tested
- Exercise Prehabilitation, Multivitamins, Standard Care (in control arm)
- Keywords
- Cancer, Colorectal Cancer, Prehabilitation, Exercise, Brain Health, Chemo-brain, Chemotherapy, Cognitive Function
- Medical subject headings
- Colorectal Neoplasms, Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise PrehabilitationBehavioural
Also called Exercise programme, exercise intervention
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.
MultivitaminsDietary 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
Participants with colorectal cancer will receive chemotherapy treatment.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation group | Experimental | 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. Receives: Behavioral: Exercise Prehabilitation; Dietary Supplement: Multivitamins; Other: Standard Care (in control arm) |
| Standard Care Group | Other | This group will receive their treatment as planned as part of standard care, but will not receive the prehabilitation (exercise, nutrition, and behavioural support). Receives: Other: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
Changes in brain activity during the Words-In-Noise Test
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.
Measured: 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).
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start7 Jul 2026
- Primary completion16 Sep 2027 (estimated)
- Study completion16 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Chris Gaffney
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Chris Gaffney, Lancaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341217
- Sponsor's protocol ID
- 25/EM/0250
- Other IDs
- AR2024.07
- Acronym
- CHEMOBRAIN
- Status last verified
- Sep 2026
- First submitted
- 18 Dec 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hoad KL, Ton C, Williamson D, Subar DA, Nuttall HE, Gaffney CJ. The role of prehabilitation in improving brain health and cognition after chemotherapy in patients with colorectal cancer: Study protocol of the Chemo Brain Prehab Project. PLoS One. 2026 Mar 3;21(3):e0341996. doi: 10.1371/journal.pone.0341996. eCollection 2026.
PubMed 41774738
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemo Brain Prehab Project: Improving Brain Health After Chemotherapy Through Prehabilitation
- ClinicalTrials.gov ID
- NCT07341217
- Acronym / sponsor ID
- CHEMOBRAIN / 25/EM/0250
- Keywords
- Cancer, Colorectal Cancer, Prehabilitation, Exercise, Brain Health, Chemo-brain, Chemotherapy, Cognitive Function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Dr. Chris GaffneyUniversity, hospital or other
- Study start
- 7 Jul 2026 (actual)
- Primary completion
- 16 Sep 2027 (estimated)
- Study completion
- 16 Sep 2027 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Assessments will take place at three time points:
- Visit 1 (baseline): 3-4 weeks before chemotherapy.
- Visit 2: Within 72 hours of starting chemotherapy.
- Visit 3: 3-4 days after the final chemotherapy session. A follow-up will occur three months after chemotherapy. At each assessment, functional fitness, blood samples, brain activity (EEG), cognitive tests, and quality of life questionnaires will be completed.
While there is no guarantee of direct benefit, participation may improve fitness, reduce fatigue, and enhance quality of life during chemotherapy. Exercise can also support mood, manage anxiety and depression, and potentially lessen cognitive changes linked to chemotherapy. Participants will contribute to research that could help improve future cancer care.
Risks are minimal and will be closely managed. All tests will be conducted under medical supervision with appropriate screening, warm-ups, and safety procedures in place. Exercise carries a small risk of muscle strain, but exercises will be tailored to ability.
EEG recordings are safe, though mild skin irritation may occur from the cap or cleaning solution. Blood sampling can cause minor bruising or discomfort, but it will be performed by trained professionals. Cognitive testing may occasionally cause fatigue or frustration.
All procedures will take place in hospital settings with immediate access to medical staff. Any clinical concerns identified during testing will be reported to the participant's oncology team or helpline, following consent procedures. The study will not alter or interfere with normal clinical care.
All data, including personal contact information, will be securely managed within Lancaster University's Microsoft Teams environment, ensuring full GDPR compliance. The study is run by Lancaster University in collaboration with East Lancashire Teaching Hospitals NHS Trust, Lancashire Teaching Hospital NHS Trust, and University Hospitals of Morecambe Bay NHS Trust. Recruitment and testing will take place across all participating sites.
The study is due to begin in early 2026 and will run until September 2027. This study is funded by North West Cancer Research.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation group | Experimental | Behavioral: Exercise Prehabilitation, Dietary Supplement: Multivitamins, Other: Standard Care (in control arm)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. |
| Standard Care Group | Other | Other: Standard Care (in control arm)This group will receive their treatment as planned as part of standard care, but will not receive the prehabilitation (exercise, nutrition, and behavioural support). |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise PrehabilitationAlso: Exercise programme, exercise interventionThe 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. | Behavioural | Prehabilitation group |
| MultivitaminsMultivitamins 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. | Dietary supplement | Prehabilitation group |
| Standard Care (in control arm)Participants with colorectal cancer will receive chemotherapy treatment. | Other | Prehabilitation group, Standard Care Group |
Primary outcome
Blood-based markers
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).
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
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).
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
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).
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
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).
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
Time frame: 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.
1 secondary outcome
Change in Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) total score
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Derived from this study: PubMed 41774738Hoad KL, Ton C, Williamson D, Subar DA, Nuttall HE, Gaffney CJ. The role of prehabilitation in improving brain health and cognition after chemotherapy in patients with colorectal cancer: Study protocol of the Chemo Brain Prehab Project. PLoS One. 2026 Mar 3;21(3):e0341996. doi: 10.1371/journal.pone.0341996. eCollection 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher Gaffney, BSc (Hons.) MSc PhD FHEA contact
Katie L Hoad, BSc (Hons.) MSc PhD contact
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Prehabilitation and Multivitamins in people with Colorectal Cancer and Older Adults (60 - 85 Years Old), run by Dr. Chris Gaffney at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Gaffney, BSc (Hons.) MSc PhD FHEA (+44 (0) 1524 593 602 ext. 0044, c.gaffney@lancaster.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood-based markers (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).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07341217, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026; AzTrials last refreshed its copy on 27 Oct 2026.