Breast CancerNCT03476070
Adolescent and Young Adult Cancer Patients: Cognitive Toxicity on Survivorship (ACTS)
An observational study of Breast Cancer and Lymphoma, run by National University of Singapore at 3 sites in Singapore.
Trial summary
This study aims to evaluate the prevalence, biological mechanism and survivorship impact of cognitive toxicity among adolescent and young adult (AYA) patients diagnosed with curable cancers. Read more about this study
- Who is it for?
- Ages 15 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Lymphoma, Germ Cell Tumor
- How many people
- 236 participants
- Where
- 3 sitesSingapore
- Study dates
- 18 Jun 2018to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 15 to 39 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The proposed study will be a multicenter, prospective, longitudinal, observational study conducted at the National Cancer Centre Singapore (NCCS) and KK Women's and Children's Hospital (KKH).
Who may be able to join
- between 15-39 years of age
- newly diagnosed with breast cancer, lymphoma or germ cell tumor with treatment intent determined as curative by medical oncologist
- scheduled for chemotherapy with or without non-cranial radiotherapy
- no prior history of chemotherapy and/or radiotherapy
- able to read and understand English
- capable of giving informed consent (or obtaining parents' consent if required)
Who cannot join
- physically or mentally incapable of providing verbal/written consent
- diagnosed with primary or metastatic brain tumor(s) or relapsed disease
- treatment includes intrathecal or intraventricular chemotherapy
- evidence of psychosis or underlying neuropsychiatric illness that may impair cognitive abilities
- have immediate family member who is enrolled as in the healthy control arm
- any contraindication to MRI as stated in the study protocol including: pregnancy, metal fragments/implants in body, known claustrophobia, and non-removable metal orthodontic braces, metallic retainers and oral wires
Trial locations and contacts
3 sites in 1 country.
Singapore3 sites, 3 recruiting
- Recruiting
KK Women's and Children's Hospital
Singapore
- Recruiting
National Cancer Centre Singapore
Singapore
- Not yet recruiting
National University of Singapore
Singapore
About this study
This study aims to evaluate the prevalence, biological mechanism and survivorship impact of cognitive toxicity among adolescent and young adult (AYA) patients diagnosed with curable cancers. The hypothesis is that cognitive impairment is clinically significant among AYA cancer patients treated with chemotherapy and that there will be detectable structural and functional changes in the brain for this patient group.
Read the detailed description
A prospective longitudinal cohort study will be conducted at National Cancer Centre Singapore (NCCS) and KK Women's and Children's Hospital (KKH) from April 2018 to April 2021. Eligible cancer patients aged between 15-39 years old will be recruited and followed up for a period of 12 months. In addition, healthy individuals will also be recruited into the control arm of the study. The prevalence of cognitive impairment will be assessed via objective cognitive functional assessments in the form of the Cambridge Neuropsychological Test Automated Battery (Cantab) test scores and Functional Assessement of Cancer-Therapy Cognitive Function (FACT-Cog v3.0). The overall cognitive performance and post-treatment health issues measured by the assessment tools used would be compared between AYA cancer patients and healthy controls at baseline and 6 months after baseline.
Other post-treatment health issues will be assessed in relation to cognitive impairment with a series of questionnaires including Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) for cancer-related fatigue, the Rotterdam Symptom Checklist (RSCL) for symptom burden, the Paediatrics Quality of Life Inventory (PedsQL 4.0) for psychosocial outcomes, InCharge questionnaire for perceived financial distress and a work/education questionnaire respectively.
To enhance the understanding of the biological mechanism behind cognitive impairment, levels of biomarkers and genetic determinants will also be correlated with overall cognitive impairment. Blood plasma samples drawn from patients will be assessed for Brain-derived neutrotrophic factor (BDNF) levels, hormone levels and pro-inflammatory cytokines such as IL-1β, IL-4, and IL-6 using multiplex immunoassay. MRI scans and relevant neuroimaging techniques will be used to assess structural changes and functional connectivities in brain. Lastly, wearable devices will be utilized to track activity and lifestyle data among AYA cancer patients to investigate on the extent of impact of cognitive impairment and to assess the feasibility of using these wearables devices to personalize symptom management.
Findings from this proposed study will enhance understanding of cognitive toxicity and post-treatment health issues faced by the AYA patient group, which will facilitate the development of effective interventions to better cope with their daily lives.
- Conditions
- Breast Cancer, Lymphoma, Germ Cell Tumor, Cognitive Impairment
- Keywords
- Adolescents and Young Adults (AYA), breast cancer, lymphoma, germ cell tumor, cognitive impairment, survivorship, Singapore
- Medical subject headings
- Breast Neoplasms, Lymphoma, Neoplasms, Germ Cell and Embryonal, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AYA cancer patients | Patients (aged between 15-39) diagnosed with breast cancer, lymphoma or germ cell tumor | |
| Healthy controls | Healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of cognitive impairment in AYA cancer patients
Compare the prevalence of overall cognitive impairment at 6 months from baseline, between AYA cancer patients and healthy controls. Cognitive impairment is measured by the overall cognitive performance using the objective computer-based Cambridge Neuropsychological Test Automated Battery (Cantab ®).
Measured: 6 months post recruitment
Secondary outcomes (9)
Prevalence of impairment in each individual Cantab ® cognitive domain
The objective computer-based Cambridge Neuropsychological Test Automated Battery (Cantab ®) measures the domains attention, memory, executive function, response speed and processing speed.
Measured: 1 year post recruitment
Prevalence of self-reported cognitive impairment
Functional Assessment of Cancer Therapy-Cognition Function (FACT-Cog) a 37-item questionnaire which measures six cognitive domains: memory, concentration, mental acuity, verbal fluency, functional interference and multitasking ability. The response is based on the perceived cognitive function within the past 7 days using a 5-point Likert scale ranging from 0 as "never" to 4 as "several times a day". The individual subscales scores are summed to determine the FACT-Cog total score, ranging from 0 to 148, with higher scores indicating better cognitive functioning. Self-reported cognitive impairment is measured using the minimal clinically important difference of 10.6 points.
Measured: 1 year post recruitment
Incidence and trajectory of cancer-related fatigue
Multi-dimensional Fatigue Symptom Inventory-Short Form (MSFI-SF) is a 30-item questionnaire to assess the five domains of fatigue: general, emotional, vigour, physical and mental. The total score of the questionnaire is obtained by subtracting vigor from the sum of all domains. It ranges from -24 to 96, with a higher total score indicating increased fatigue. Cancer-related fatigue is defined using the minimal clinically important difference of 10.8 points.
Measured: 1 year post recruitment
Extent of symptom burden
Rotterdam Symptom Checklist (RSCL) is used to measure symptom-related distress. It It uses a 4-point Likert-type scales (not at all, a little, quite a bit, very much) and contains 39 items in four domains: physical symptom distress, psychological distress, activity level and overall global life quality. The higher the score, the higher the level of burden or impairment.
Measured: 1 year post recruitment
Psychosocial outcomes
Pediatrics Quality of Life Inventory (PedsQL) will be used to measure health-related quality of life in adolescents, with domains to assess both physical and psychosocial health. The psychosocial health summary score ranges from 0-100, whereby a higher score suggests a better HRQOL.
Measured: 1 year post recruitment
Extent of Financial Distress
The InCharge Financial Distress/Financial Well-Being Scale is an 8-item scale designed to assess perceived financial distress. The score is obtained by summing the number of points of each of the items and dividing the total by 8. The scale ranges from a continuum from 1 to 10 where 1 represents overwhelming financial distress/lowest financial well-being and 10 being no financial distress/highest financial well-being.
Measured: 1 year post recruitment
Biomarker levels in relation to cognitive impairment
Patients' plasma samples will be assessed for levels of BDNF, hormones and cytokines (IL1b, IL4, IL6) using multiplex immunoassay kits.
Measured: 1 year post recruitment
Neuroimaging scans
Neuroimaging using MRI (Functional-MRI, Diffusion Weighted, T1-Weighted and T2-Weighted sequences) will be used to determine functional and structural changes in brain such as gray matter volume, which are then correlated to cognitive impairment
Measured: 6 months post recruitment
Lifestyle and activity data
Wearable devices will be used to track patients' lifestyle data such as steps per day, intensity and duration of exercise and caloric expenditure.
Measured: 1 year post recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start18 Jun 2018
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandre Chan, National University of Singapore
- Investigators
- Alexandre Chan, Pharm D, Principal investigator, National University of Singapore, National Cancer Centre Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476070
- Sponsor's protocol ID
- CIRB Ref. No: 2017/3139
- Status last verified
- Sep 2021
- First submitted
- 6 Mar 2018
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sender L, Zabokrtsky KB. Adolescent and young adult patients with cancer: a milieu of unique features. Nat Rev Clin Oncol. 2015 Aug;12(8):465-80. doi: 10.1038/nrclinonc.2015.92. Epub 2015 May 26.
PubMed 26011488Nass SJ, Beaupin LK, Demark-Wahnefried W, Fasciano K, Ganz PA, Hayes-Lattin B, Hudson MM, Nevidjon B, Oeffinger KC, Rechis R, Richardson LC, Seibel NL, Smith AW. Identifying and addressing the needs of adolescents and young adults with cancer: summary of an Institute of Medicine workshop. Oncologist. 2015 Feb;20(2):186-95. doi: 10.1634/theoncologist.2014-0265. Epub 2015 Jan 7.
PubMed 25568146Tai E, Buchanan N, Townsend J, Fairley T, Moore A, Richardson LC. Health status of adolescent and young adult cancer survivors. Cancer. 2012 Oct 1;118(19):4884-91. doi: 10.1002/cncr.27445. Epub 2012 Jun 11.
PubMed 22688896Ahles TA, Root JC, Ryan EL. Cancer- and cancer treatment-associated cognitive change: an update on the state of the science. J Clin Oncol. 2012 Oct 20;30(30):3675-86. doi: 10.1200/JCO.2012.43.0116. Epub 2012 Sep 24.
PubMed 23008308Vardy J. Cognitive function in breast cancer survivors. Cancer Treat Res. 2009;151:387-419. doi: 10.1007/978-0-387-75115-3_24. No abstract available.
PubMed 19593525Cheung YT, Shwe M, Tan YP, Fan G, Ng R, Chan A. Cognitive changes in multiethnic Asian breast cancer patients: a focus group study. Ann Oncol. 2012 Oct;23(10):2547-2552. doi: 10.1093/annonc/mds029. Epub 2012 Mar 6.
PubMed 22396443Guy GP Jr, Yabroff KR, Ekwueme DU, Smith AW, Dowling EC, Rechis R, Nutt S, Richardson LC. Estimating the health and economic burden of cancer among those diagnosed as adolescents and young adults. Health Aff (Millwood). 2014 Jun;33(6):1024-31. doi: 10.1377/hlthaff.2013.1425.
PubMed 24889952Poort H, Kaal SEJ, Knoop H, Jansen R, Prins JB, Manten-Horst E, Servaes P, Husson O, van der Graaf WTA. Prevalence and impact of severe fatigue in adolescent and young adult cancer patients in comparison with population-based controls. Support Care Cancer. 2017 Sep;25(9):2911-2918. doi: 10.1007/s00520-017-3746-0. Epub 2017 May 20.
PubMed 28528350Zimmer P, Baumann FT, Oberste M, Wright P, Garthe A, Schenk A, Elter T, Galvao DA, Bloch W, Hubner ST, Wolf F. Effects of Exercise Interventions and Physical Activity Behavior on Cancer Related Cognitive Impairments: A Systematic Review. Biomed Res Int. 2016;2016:1820954. doi: 10.1155/2016/1820954. Epub 2016 Apr 10.
PubMed 27144158Treanor CJ, McMenamin UC, O'Neill RF, Cardwell CR, Clarke MJ, Cantwell M, Donnelly M. Non-pharmacological interventions for cognitive impairment due to systemic cancer treatment. Cochrane Database Syst Rev. 2016 Aug 16;2016(8):CD011325. doi: 10.1002/14651858.CD011325.pub2.
PubMed 27529826Cheung YT, Lim SR, Ho HK, Chan A. Cytokines as mediators of chemotherapy-associated cognitive changes: current evidence, limitations and directions for future research. PLoS One. 2013 Dec 5;8(12):e81234. doi: 10.1371/journal.pone.0081234. eCollection 2013.
PubMed 24339912Kronfol Z, Remick DG. Cytokines and the brain: implications for clinical psychiatry. Am J Psychiatry. 2000 May;157(5):683-94. doi: 10.1176/appi.ajp.157.5.683.
PubMed 10784457Wefel JS, Vardy J, Ahles T, Schagen SB. International Cognition and Cancer Task Force recommendations to harmonise studies of cognitive function in patients with cancer. Lancet Oncol. 2011 Jul;12(7):703-8. doi: 10.1016/S1470-2045(10)70294-1. Epub 2011 Feb 25.
PubMed 21354373Chan A, Yo TE, Wang XJ, Ng T, Chae JW, Yeo HL, Shwe M, Gan YX. Minimal Clinically Important Difference of the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) for Fatigue Worsening in Asian Breast Cancer Patients. J Pain Symptom Manage. 2018 Mar;55(3):992-997.e2. doi: 10.1016/j.jpainsymman.2017.10.014. Epub 2017 Oct 31.
PubMed 29097274Chan A, Chan D, Agrawal P, Beppu LL, Kober K, Ng DQ, Sayer M, Trudeau J. Trajectory and predictors of cancer- and treatment-related fatigue (CRF) in adolescent and young adult cancer patients: a prospective, longitudinal study. BMC Cancer. 2026 Jun 16. doi: 10.1186/s12885-026-16324-4. Online ahead of print.
PubMed 42304319
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent and Young Adult Cancer Patients: Cognitive Toxicity on Survivorship (ACTS)
- ClinicalTrials.gov ID
- NCT03476070
- Acronym / sponsor ID
- CIRB Ref. No: 2017/3139
- Conditions
- Breast Cancer, Lymphoma, Germ Cell Tumor, Cognitive Impairment
- Keywords
- Adolescents and Young Adults (AYA), breast cancer, lymphoma, germ cell tumor, cognitive impairment, survivorship, Singapore
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 23 Mar 2018 (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.
This study aims to evaluate the prevalence, biological mechanism and survivorship impact of cognitive toxicity among adolescent and young adult (AYA) patients diagnosed with curable cancers. The hypothesis is that cognitive impairment is clinically significant among AYA cancer patients treated with chemotherapy and that there will be detectable structural and functional changes in the brain for this patient group.
Detailed description
A prospective longitudinal cohort study will be conducted at National Cancer Centre Singapore (NCCS) and KK Women's and Children's Hospital (KKH) from April 2018 to April 2021. Eligible cancer patients aged between 15-39 years old will be recruited and followed up for a period of 12 months. In addition, healthy individuals will also be recruited into the control arm of the study. The prevalence of cognitive impairment will be assessed via objective cognitive functional assessments in the form of the Cambridge Neuropsychological Test Automated Battery (Cantab) test scores and Functional Assessement of Cancer-Therapy Cognitive Function (FACT-Cog v3.0). The overall cognitive performance and post-treatment health issues measured by the assessment tools used would be compared between AYA cancer patients and healthy controls at baseline and 6 months after baseline.
Other post-treatment health issues will be assessed in relation to cognitive impairment with a series of questionnaires including Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) for cancer-related fatigue, the Rotterdam Symptom Checklist (RSCL) for symptom burden, the Paediatrics Quality of Life Inventory (PedsQL 4.0) for psychosocial outcomes, InCharge questionnaire for perceived financial distress and a work/education questionnaire respectively.
To enhance the understanding of the biological mechanism behind cognitive impairment, levels of biomarkers and genetic determinants will also be correlated with overall cognitive impairment. Blood plasma samples drawn from patients will be assessed for Brain-derived neutrotrophic factor (BDNF) levels, hormone levels and pro-inflammatory cytokines such as IL-1β, IL-4, and IL-6 using multiplex immunoassay. MRI scans and relevant neuroimaging techniques will be used to assess structural changes and functional connectivities in brain. Lastly, wearable devices will be utilized to track activity and lifestyle data among AYA cancer patients to investigate on the extent of impact of cognitive impairment and to assess the feasibility of using these wearables devices to personalize symptom management.
Findings from this proposed study will enhance understanding of cognitive toxicity and post-treatment health issues faced by the AYA patient group, which will facilitate the development of effective interventions to better cope with their daily lives.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AYA cancer patients | – | –Patients (aged between 15-39) diagnosed with breast cancer, lymphoma or germ cell tumor |
| Healthy controls | – | –Healthy controls |
Who may qualify
- Ages
- 15 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The proposed study will be a multicenter, prospective, longitudinal, observational study conducted at the National Cancer Centre Singapore (NCCS) and KK Women's and Children's Hospital (KKH).
Key inclusion criteria (6 listed)
- between 15-39 years of age
- newly diagnosed with breast cancer, lymphoma or germ cell tumor with treatment intent determined as curative by medical oncologist
- scheduled for chemotherapy with or without non-cranial radiotherapy
- no prior history of chemotherapy and/or radiotherapy
- able to read and understand English
Key exclusion criteria (6 listed)
- physically or mentally incapable of providing verbal/written consent
- diagnosed with primary or metastatic brain tumor(s) or relapsed disease
- treatment includes intrathecal or intraventricular chemotherapy
- evidence of psychosis or underlying neuropsychiatric illness that may impair cognitive abilities
- have immediate family member who is enrolled as in the healthy control arm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of cognitive impairment in AYA cancer patients
Time frame: 6 months post recruitment
Compare the prevalence of overall cognitive impairment at 6 months from baseline, between AYA cancer patients and healthy controls. Cognitive impairment is measured by the overall cognitive performance using the objective computer-based Cambridge Neuropsychological Test Automated Battery (Cantab ®).
9 secondary outcomes
Prevalence of impairment in each individual Cantab ® cognitive domain
Time frame: 1 year post recruitment
Prevalence of self-reported cognitive impairment
Time frame: 1 year post recruitment
Incidence and trajectory of cancer-related fatigue
Time frame: 1 year post recruitment
Extent of symptom burden
Time frame: 1 year post recruitment
Psychosocial outcomes
Time frame: 1 year post recruitment
Extent of Financial Distress
Time frame: 1 year post recruitment
Biomarker levels in relation to cognitive impairment
Time frame: 1 year post recruitment
Neuroimaging scans
Time frame: 6 months post recruitment
Lifestyle and activity data
Time frame: 1 year post recruitment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Background: PubMed 26011488Sender L, Zabokrtsky KB. Adolescent and young adult patients with cancer: a milieu of unique features. Nat Rev Clin Oncol. 2015 Aug;12(8):465-80. doi: 10.1038/nrclinonc.2015.92. Epub 2015 May 26.
- Background: PubMed 25568146Nass SJ, Beaupin LK, Demark-Wahnefried W, Fasciano K, Ganz PA, Hayes-Lattin B, Hudson MM, Nevidjon B, Oeffinger KC, Rechis R, Richardson LC, Seibel NL, Smith AW. Identifying and addressing the needs of adolescents and young adults with cancer: summary of an Institute of Medicine workshop. Oncologist. 2015 Feb;20(2):186-95. doi: 10.1634/theoncologist.2014-0265. Epub 2015 Jan 7.
- Background: PubMed 22688896Tai E, Buchanan N, Townsend J, Fairley T, Moore A, Richardson LC. Health status of adolescent and young adult cancer survivors. Cancer. 2012 Oct 1;118(19):4884-91. doi: 10.1002/cncr.27445. Epub 2012 Jun 11.
- Background: PubMed 23008308Ahles TA, Root JC, Ryan EL. Cancer- and cancer treatment-associated cognitive change: an update on the state of the science. J Clin Oncol. 2012 Oct 20;30(30):3675-86. doi: 10.1200/JCO.2012.43.0116. Epub 2012 Sep 24.
- Background: PubMed 19593525Vardy J. Cognitive function in breast cancer survivors. Cancer Treat Res. 2009;151:387-419. doi: 10.1007/978-0-387-75115-3_24. No abstract available.
- Background: PubMed 22396443Cheung YT, Shwe M, Tan YP, Fan G, Ng R, Chan A. Cognitive changes in multiethnic Asian breast cancer patients: a focus group study. Ann Oncol. 2012 Oct;23(10):2547-2552. doi: 10.1093/annonc/mds029. Epub 2012 Mar 6.
- Background: PubMed 24889952Guy GP Jr, Yabroff KR, Ekwueme DU, Smith AW, Dowling EC, Rechis R, Nutt S, Richardson LC. Estimating the health and economic burden of cancer among those diagnosed as adolescents and young adults. Health Aff (Millwood). 2014 Jun;33(6):1024-31. doi: 10.1377/hlthaff.2013.1425.
- Background: PubMed 28528350Poort H, Kaal SEJ, Knoop H, Jansen R, Prins JB, Manten-Horst E, Servaes P, Husson O, van der Graaf WTA. Prevalence and impact of severe fatigue in adolescent and young adult cancer patients in comparison with population-based controls. Support Care Cancer. 2017 Sep;25(9):2911-2918. doi: 10.1007/s00520-017-3746-0. Epub 2017 May 20.
- Background: PubMed 27144158Zimmer P, Baumann FT, Oberste M, Wright P, Garthe A, Schenk A, Elter T, Galvao DA, Bloch W, Hubner ST, Wolf F. Effects of Exercise Interventions and Physical Activity Behavior on Cancer Related Cognitive Impairments: A Systematic Review. Biomed Res Int. 2016;2016:1820954. doi: 10.1155/2016/1820954. Epub 2016 Apr 10.
- Background: PubMed 27529826Treanor CJ, McMenamin UC, O'Neill RF, Cardwell CR, Clarke MJ, Cantwell M, Donnelly M. Non-pharmacological interventions for cognitive impairment due to systemic cancer treatment. Cochrane Database Syst Rev. 2016 Aug 16;2016(8):CD011325. doi: 10.1002/14651858.CD011325.pub2.
- Background: PubMed 24339912Cheung YT, Lim SR, Ho HK, Chan A. Cytokines as mediators of chemotherapy-associated cognitive changes: current evidence, limitations and directions for future research. PLoS One. 2013 Dec 5;8(12):e81234. doi: 10.1371/journal.pone.0081234. eCollection 2013.
- Background: PubMed 10784457Kronfol Z, Remick DG. Cytokines and the brain: implications for clinical psychiatry. Am J Psychiatry. 2000 May;157(5):683-94. doi: 10.1176/appi.ajp.157.5.683.
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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. This study is not recruiting at the moment.
Alexandre Chan, Pharm D principal investigator
National University of Singapore, National Cancer Centre Singapore
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Lymphoma, run by National University of Singapore at 3 sites in Singapore.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandre Chan, Pharm D (65-81688672, phaac@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of cognitive impairment in AYA cancer patients (time frame: 6 months post recruitment). 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 NCT03476070, which also lists 17 linked publications.
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 5 Sep 2021.