Breast CancerPhase 4NCT06406127
Effect of Alpha Lipoic Acid on Chemotherapy Induced Neurological Changes in Breast Cancer Patients
A Phase 4 study testing Alpha Lipoic Acid 600 MG Oral Capsule in people with Breast Cancer and Alpha Lipoic Acid, run by Ain Shams University at 1 site in Egypt.
Trial summary
92 female cancer patients, aged from 18 to 75 years old (with a first diagnosis of breast cancer) who will receive Paclitaxel-based chemotherapy (12 weeks) as first line therapy, will be enrolled in the study and will be randomly assigned to either: Group I: will receive the chemotherapy protocol or Group II: will… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Alpha Lipoic Acid, Paclitaxel
- What is being tested?
- Alpha Lipoic Acid 600 MG Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 1 Apr 2025
- Phase
- Phase 4
- 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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female breast cancer patients aged 18 to 75 years old.
- Patients with a first diagnosis of cancer and indication for first-line therapy with Paclitaxel-based chemotherapy.
- Patients are those who are diagnosed with Stage 1 to 3 non-metastatic breast cancer.
- Patients are intended to receive 12 weeks of paclitaxel (75 - 80 mg/m2) according to the TC protocol.
- No previous neurological conditions (including dementia, Alzheimer's disease, Parkinson's disease) and taking no neurological-related drugs.
- Normal hepatic and renal function (bilirubin ≤1.5 mg/dL, creatinine ≤2.0 mg/dL).
- Eastern Cooperative Oncology Group (ECOG) performance status from 0 - 2.
- Patient Health Questionnaire (PHQ) score from 0 - 9.
Who cannot join
- Hypersensitivity / Allergy to Alpha Lipoic Acid.
- Any condition that contraindicates chemotherapy (i.e., pregnancy, lactation).
- New-onset neurological symptoms or presence of any neurological disorder.
- Patients with known history or current treatment with neurological agents.
- Alcohol abuse.
- Current participation in any other clinical investigation.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Dar El Salam Cancer Hospital (Harmel Hospital)
Cairo, El Malek El Saleh, 11559
Shaimaa M Shaker, Pharmacist, +2001119894331 ext. +20, shaimaamohamed63@gmail.com
Loay M Kassem, Physician
About this study
92 female cancer patients, aged from 18 to 75 years old (with a first diagnosis of breast cancer) who will receive Paclitaxel-based chemotherapy (12 weeks) as first line therapy, will be enrolled in the study and will be randomly assigned to either:
- Group I: will receive the chemotherapy protocol or
- Group II: will receive the chemotherapy protocol plus 600 mg daily dose of Alpha Lipoic Acid for 14 weeks (one week before the start of paclitaxel and continue till one week after the end of paclitaxel).
- Blood samples will be withdrawn 2 times (week 1 and week 12) to measure the following: (Stored in -80 C till the end of the study)
- Tumor Necrotizing Factor- alpha (TNF-α) by ELISA.
- Brain-Derived Neurotrophic Factor (BDNF) by ELISA.
- All patients will be subjected to 6 tests/questionnaires (week 1 - week 12 - week 24) to predict the functionality of the brain:
- Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog) version 3
- Mini-Cog Test
- Mini Mental State Examination (MMSE)
- Controlled Oral Word Association Test (COWAT)
- Hopkins Verbal Learning Test (HVLT)
- Trail Making Test (TMT)
Read the detailed description
92 Female Cancer patients will be randomized to 2 groups, the first group will receive the alpha lipoic acid beside their chemotherapy regimen and the other group will only receive the chemotherapy regimen. Both groups will be watched for any changes in their neurological behaviors by asking and receiving answers on the questionnaires that were mentioned before. This will be done in 3 different time margins:
- Before starting the chemotherapeutic regimen
- after ending the chemotherapeutic regimen
- after 6 months of receiving the chemotherapeutic regimen this will show even the late symptoms and effects of the chemotherapy. Also serum biomarkers will be measured (TNF alpha and BDNF) 2 times; one before starting the chemotherapeutic regimen and the other after ending the treatment.
Throughout the treatment process, both groups will be monitored for any side effects concerning the alpha lipoic acid or the chemotherapeutic regimen.
- Conditions
- Breast Cancer, Alpha Lipoic Acid, Paclitaxel, Neurologic Disorder, Chemotherapy
- Being tested
- Alpha Lipoic Acid 600 MG Oral Capsule
- Medical subject headings
- Breast Neoplasms, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha Lipoic Acid 600 MG Oral CapsuleDrug
Also called No drug
Single 600 mg daily dose
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy + Alpha Lipoic Acid | Experimental | will receive chemotherapy (paclitaxel for 12 weeks) + Alpha Lipoic Acid for 14 weeks (one week before the start of paclitaxel and continue for one week after the end of paclitaxel). Receives: Drug: Alpha Lipoic Acid 600 MG Oral Capsule |
| Chemotherapy only | No intervention | will receive chemotherapy only (paclitaxel for 12 weeks). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Necrotizing Factor Alpha Serum Levels
All patients will be evaluated during the trial for 2 times via monitoring the Tumor Necrotizing Factor- alpha (TNF-α).
Measured: At baseline of treatment and After 12 weeks of the paclitaxel-based therapy (at the end of therapy)
Secondary outcomes (7)
Response assessment by questionnaire - FACT-COG Test
Evaluation of response will be done guided by the questionnaire to detect the neuropsychiatric panel.
FACT Cognitive function version 3 consists of questions regarding:
- Perceived cognitive impairments.
- Comments from others.
- Perceived cognitive abilities.
- Impact on quality of life. For every answered question, the patient receives points on a scale of scores. Those scales will be compared in every time the questionnaire is conducted to assess the functionality of the brain.
The scale of numbers of the answers is:
- Never = 0
- About once a week = 1
- Two to three times a week = 2
- Nearly every day = 3
- Several times a day = 4 It is better when the patient has low score.
Measured: For 3 times during the study: - At baseline - After 12 weeks of the paclitaxel-based therapy. - After 6 months from the start of the paclitaxel-based therapy.
Response assessment by questionnaire - Mini-Cog Test
Evaluation of response will be done guided by the questionnaire to detect the neuropsychiatric panel.
Mini-Cog Test consists of three steps:
- Three Word Registration: Telling the patient a list of words and ask him to memorize them.
- Clock Drawing: Asking the patient to draw the clock and record the time taken for drawing. Normal clock = 2 points. Inability or refusal to draw a clock (abnormal) = 0 points.
- Three-Word Recall: Asking the patient to recall the list of words done in step 1.
For every word recalled, patient receives a point. Total points will be compared in every time the questionnaire is done to assess the functionality of the brain.
Measured: For 3 times during the study: - At baseline - After 12 weeks of the paclitaxel-based therapy. - After 6 months from the start of the paclitaxel-based therapy.
Response assessment by questionnaire - Mini Mental State Examination (MMSE)
Evaluation of response will be done guided by the questionnaire to detect the neuropsychiatric panel.
MMSE consists of questions regarding:
- Orientation to time (2 points, one for each question)
- Orientation to place (2 points, one for each question)
- Concentration and attention (2 questions and for each question this scale will be applied: No Errors - 2 points, 1 Error - 1 point, 2 or more Errors - 0 points)
- Delayed recall (3 points, one for each recalled word) For every answered question, the patient will get points. Those points will be compared in every phase the questionnaire is done for every patient.
Measured: For 3 times during the study: - At baseline - After 12 weeks of the paclitaxel-based therapy. - After 6 months from the start of the paclitaxel-based therapy.
Response assessment by questionnaire - Controlled Oral Word Association Test (COWAT)
Evaluation of response will be done guided by the questionnaire to detect the neuropsychiatric panel.
The patient is asked to tell words that begin with a certain alphabet in a certain time margin. This will be done for 4 different alphabets and words will be recorded to calculate the score.
Points of every alphabet will be compared in every time the questionnaire is conducted to assess the functionality of the brain.
The more words told in the same time margin, the better.
Measured: For 3 times during the study: - At baseline - After 12 weeks of the paclitaxel-based therapy. - After 6 months from the start of the paclitaxel-based therapy.
Response assessment by questionnaire - The Verbal Memory Arabic Test (VMAT)
Evaluation of response will be done guided by the questionnaire to detect the neuropsychiatric panel.
The VMAT consists of 3 trials of delayed recall. Every trial has a list of words for which the patient will be asked to recall. For every recalled word the patient will have a point and those points will be compared in every time the questionnaire is conducted to assess the functionality of the brain.
The more words recalled, the better.
Measured: For 3 times during the study: - At baseline - After 12 weeks of the paclitaxel-based therapy. - After 6 months from the start of the paclitaxel-based therapy.
Response assessment by questionnaire - Trail Making Test (TMT)
Evaluation of response will be done guided by the questionnaire to detect the neuropsychiatric panel.
TMT consists of 2 parts, A and B. Both parts of the Trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers and letters; as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.).
Results for both TMT A and B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.
Measured: For 3 times during the study: - At baseline - After 12 weeks of the paclitaxel-based therapy. - After 6 months from the start of the paclitaxel-based therapy.
Brain Derived Neurotrophic Factor Serum Levels
All patients will be evaluated during the trial for 2 times via monitoring Brain-Derived Neurotrophic Factor (BDNF) serum levels.
Measured: At baseline and After 12 weeks of the paclitaxel-based therapy (at the end of therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start1 Apr 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)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 Ain Shams UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Dar EL Salam Cancer Hospital
- Responsible party
- Principal investigator, Shaimaa Mohamed SafaaElDin, Ain Shams University
- Investigators
- Manal H El Hamamsy, Doctorate, Principal investigator, Ain Shams University - Faculty of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406127
- Sponsor's protocol ID
- RHDIRB2020110301 REC #247
- Status last verified
- May 2024
- First submitted
- 19 Apr 2024
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
NCD Countdown 2030 collaborators. NCD Countdown 2030: worldwide trends in non-communicable disease mortality and progress towards Sustainable Development Goal target 3.4. Lancet. 2018 Sep 22;392(10152):1072-1088. doi: 10.1016/S0140-6736(18)31992-5. Epub 2018 Sep 20.
PubMed 30264707Rostom Y, Abdelmoneim SE, Shaker M, Mahmoud N. Presentation and management of female breast cancer in Egypt. East Mediterr Health J. 2022 Oct 30;28(10):725-732. doi: 10.26719/emhj.22.076.
PubMed 36382727Brown T, McElroy T, Simmons P, Walters H, Ntagwabira F, Wang J, Byrum SD, Allen AR. Cognitive impairment resulting from treatment with docetaxel, doxorubicin, and cyclophosphamide. Brain Res. 2021 Jun 1;1760:147397. doi: 10.1016/j.brainres.2021.147397. Epub 2021 Mar 8.
PubMed 33705788Bellens A, Roelant E, Sabbe B, Peeters M, van Dam PA. A video-game based cognitive training for breast cancer survivors with cognitive impairment: A prospective randomized pilot trial. Breast. 2020 Oct;53:23-32. doi: 10.1016/j.breast.2020.06.003. Epub 2020 Jun 12.
PubMed 32554133Janelsins MC, Kohli S, Mohile SG, Usuki K, Ahles TA, Morrow GR. An update on cancer- and chemotherapy-related cognitive dysfunction: current status. Semin Oncol. 2011 Jun;38(3):431-8. doi: 10.1053/j.seminoncol.2011.03.014.
PubMed 21600374Lee JH, Nan A. Combination drug delivery approaches in metastatic breast cancer. J Drug Deliv. 2012;2012:915375. doi: 10.1155/2012/915375. Epub 2012 Apr 26.
PubMed 22619725Emadi A, Jones RJ, Brodsky RA. Cyclophosphamide and cancer: golden anniversary. Nat Rev Clin Oncol. 2009 Nov;6(11):638-47. doi: 10.1038/nrclinonc.2009.146. Epub 2009 Sep 29.
PubMed 19786984Inagaki M, Yoshikawa E, Matsuoka Y, Sugawara Y, Nakano T, Akechi T, Wada N, Imoto S, Murakami K, Uchitomi Y. Smaller regional volumes of brain gray and white matter demonstrated in breast cancer survivors exposed to adjuvant chemotherapy. Cancer. 2007 Jan 1;109(1):146-56. doi: 10.1002/cncr.22368.
PubMed 17131349Schultz C, Engelhardt M. Anatomy of the hippocampal formation. Front Neurol Neurosci. 2014;34:6-17. doi: 10.1159/000360925. Epub 2014 Apr 16.
PubMed 24777126Anderson JE, Trujillo M, McElroy T, Groves T, Alexander T, Kiffer F, Allen AR. Early Effects of Cyclophosphamide, Methotrexate, and 5-Fluorouracil on Neuronal Morphology and Hippocampal-Dependent Behavior in a Murine Model. Toxicol Sci. 2020 Jan 1;173(1):156-170. doi: 10.1093/toxsci/kfz213.
PubMed 31651976Yap NY, Toh YL, Tan CJ, Acharya MM, Chan A. Relationship between cytokines and brain-derived neurotrophic factor (BDNF) in trajectories of cancer-related cognitive impairment. Cytokine. 2021 Aug;144:155556. doi: 10.1016/j.cyto.2021.155556. Epub 2021 May 10.
PubMed 33985854Sommer C, Kress M. Recent findings on how proinflammatory cytokines cause pain: peripheral mechanisms in inflammatory and neuropathic hyperalgesia. Neurosci Lett. 2004 May 6;361(1-3):184-7. doi: 10.1016/j.neulet.2003.12.007.
PubMed 15135924Werida RH, Elshafiey RA, Ghoneim A, Elzawawy S, Mostafa TM. Role of alpha-lipoic acid in counteracting paclitaxel- and doxorubicin-induced toxicities: a randomized controlled trial in breast cancer patients. Support Care Cancer. 2022 Sep;30(9):7281-7292. doi: 10.1007/s00520-022-07124-0. Epub 2022 May 21.
PubMed 35596774Odabasoglu F, Halici Z, Aygun H, Halici M, Atalay F, Cakir A, Cadirci E, Bayir Y, Suleyman H. alpha-Lipoic acid has anti-inflammatory and anti-oxidative properties: an experimental study in rats with carrageenan-induced acute and cotton pellet-induced chronic inflammations. Br J Nutr. 2011 Jan;105(1):31-43. doi: 10.1017/S0007114510003107. Epub 2010 Nov 15.
PubMed 21073761Biewenga GP, Haenen GR, Bast A. The pharmacology of the antioxidant lipoic acid. Gen Pharmacol. 1997 Sep;29(3):315-31. doi: 10.1016/s0306-3623(96)00474-0.
PubMed 9378235
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Alpha Lipoic Acid on Chemotherapy Induced Neurological Changes in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06406127
- Acronym / sponsor ID
- RHDIRB2020110301 REC #247
- Conditions
- Breast Cancer, Alpha Lipoic Acid, Paclitaxel, Neurologic Disorder, Chemotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Dar EL Salam Cancer Hospital
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 9 May 2024 (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.
92 female cancer patients, aged from 18 to 75 years old (with a first diagnosis of breast cancer) who will receive Paclitaxel-based chemotherapy (12 weeks) as first line therapy, will be enrolled in the study and will be randomly assigned to either:
- Group I: will receive the chemotherapy protocol or
- Group II: will receive the chemotherapy protocol plus 600 mg daily dose of Alpha Lipoic Acid for 14 weeks (one week before the start of paclitaxel and continue till one week after the end of paclitaxel).
- Blood samples will be withdrawn 2 times (week 1 and week 12) to measure the following: (Stored in -80 C till the end of the study)
- Tumor Necrotizing Factor- alpha (TNF-α) by ELISA.
- Brain-Derived Neurotrophic Factor (BDNF) by ELISA.
- All patients will be subjected to 6 tests/questionnaires (week 1 - week 12 - week 24) to predict the functionality of the brain:
- Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog) version 3
- Mini-Cog Test
- Mini Mental State Examination (MMSE)
- Controlled Oral Word Association Test (COWAT)
- Hopkins Verbal Learning Test (HVLT)
- Trail Making Test (TMT)
Detailed description
92 Female Cancer patients will be randomized to 2 groups, the first group will receive the alpha lipoic acid beside their chemotherapy regimen and the other group will only receive the chemotherapy regimen. Both groups will be watched for any changes in their neurological behaviors by asking and receiving answers on the questionnaires that were mentioned before. This will be done in 3 different time margins:
- Before starting the chemotherapeutic regimen
- after ending the chemotherapeutic regimen
- after 6 months of receiving the chemotherapeutic regimen this will show even the late symptoms and effects of the chemotherapy. Also serum biomarkers will be measured (TNF alpha and BDNF) 2 times; one before starting the chemotherapeutic regimen and the other after ending the treatment.
Throughout the treatment process, both groups will be monitored for any side effects concerning the alpha lipoic acid or the chemotherapeutic regimen.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy + Alpha Lipoic Acid | Experimental | Drug: Alpha Lipoic Acid 600 MG Oral Capsulewill receive chemotherapy (paclitaxel for 12 weeks) + Alpha Lipoic Acid for 14 weeks (one week before the start of paclitaxel and continue for one week after the end of paclitaxel). |
| Chemotherapy only | No intervention | –will receive chemotherapy only (paclitaxel for 12 weeks). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female breast cancer patients aged 18 to 75 years old.
- Patients with a first diagnosis of cancer and indication for first-line therapy with Paclitaxel-based chemotherapy.
- Patients are those who are diagnosed with Stage 1 to 3 non-metastatic breast cancer.
- Patients are intended to receive 12 weeks of paclitaxel (75 - 80 mg/m2) according to the TC protocol.
- No previous neurological conditions (including dementia, Alzheimer's disease, Parkinson's disease) and taking no neurological-related drugs.
Key exclusion criteria (6 listed)
- Hypersensitivity / Allergy to Alpha Lipoic Acid.
- Any condition that contraindicates chemotherapy (i.e., pregnancy, lactation).
- New-onset neurological symptoms or presence of any neurological disorder.
- Patients with known history or current treatment with neurological agents.
- Alcohol abuse.
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 |
|---|---|---|
| Alpha Lipoic Acid 600 MG Oral CapsuleAlso: No drugSingle 600 mg daily dose | Drug | Chemotherapy + Alpha Lipoic Acid |
Primary outcome
Tumor Necrotizing Factor Alpha Serum Levels
Time frame: At baseline of treatment and After 12 weeks of the paclitaxel-based therapy (at the end of therapy)
All patients will be evaluated during the trial for 2 times via monitoring the Tumor Necrotizing Factor- alpha (TNF-α).
7 secondary outcomes
Response assessment by questionnaire - FACT-COG Test
Time frame: For 3 times during the study: - At baseline - After 12 weeks of the paclitaxel-based therapy. - After 6 months from the start of the paclitaxel-based therapy.
Response assessment by questionnaire - Mini-Cog Test
Time frame: For 3 times during the study: - At baseline - After 12 weeks of the paclitaxel-based therapy. - After 6 months from the start of the paclitaxel-based therapy.
Response assessment by questionnaire - Mini Mental State Examination (MMSE)
Time frame: For 3 times during the study: - At baseline - After 12 weeks of the paclitaxel-based therapy. - After 6 months from the start of the paclitaxel-based therapy.
Response assessment by questionnaire - Controlled Oral Word Association Test (COWAT)
Time frame: For 3 times during the study: - At baseline - After 12 weeks of the paclitaxel-based therapy. - After 6 months from the start of the paclitaxel-based therapy.
Response assessment by questionnaire - The Verbal Memory Arabic Test (VMAT)
Time frame: For 3 times during the study: - At baseline - After 12 weeks of the paclitaxel-based therapy. - After 6 months from the start of the paclitaxel-based therapy.
Response assessment by questionnaire - Trail Making Test (TMT)
Time frame: For 3 times during the study: - At baseline - After 12 weeks of the paclitaxel-based therapy. - After 6 months from the start of the paclitaxel-based therapy.
Brain Derived Neurotrophic Factor Serum Levels
Time frame: At baseline and After 12 weeks of the paclitaxel-based therapy (at the end of therapy)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Results publication: PubMed 30264707NCD Countdown 2030 collaborators. NCD Countdown 2030: worldwide trends in non-communicable disease mortality and progress towards Sustainable Development Goal target 3.4. Lancet. 2018 Sep 22;392(10152):1072-1088. doi: 10.1016/S0140-6736(18)31992-5. Epub 2018 Sep 20.
- Results publication: PubMed 36382727Rostom Y, Abdelmoneim SE, Shaker M, Mahmoud N. Presentation and management of female breast cancer in Egypt. East Mediterr Health J. 2022 Oct 30;28(10):725-732. doi: 10.26719/emhj.22.076.
- Results publication: PubMed 33705788Brown T, McElroy T, Simmons P, Walters H, Ntagwabira F, Wang J, Byrum SD, Allen AR. Cognitive impairment resulting from treatment with docetaxel, doxorubicin, and cyclophosphamide. Brain Res. 2021 Jun 1;1760:147397. doi: 10.1016/j.brainres.2021.147397. Epub 2021 Mar 8.
- Results publication: PubMed 32554133Bellens A, Roelant E, Sabbe B, Peeters M, van Dam PA. A video-game based cognitive training for breast cancer survivors with cognitive impairment: A prospective randomized pilot trial. Breast. 2020 Oct;53:23-32. doi: 10.1016/j.breast.2020.06.003. Epub 2020 Jun 12.
- Results publication: PubMed 21600374Janelsins MC, Kohli S, Mohile SG, Usuki K, Ahles TA, Morrow GR. An update on cancer- and chemotherapy-related cognitive dysfunction: current status. Semin Oncol. 2011 Jun;38(3):431-8. doi: 10.1053/j.seminoncol.2011.03.014.
- Results publication: PubMed 22619725Lee JH, Nan A. Combination drug delivery approaches in metastatic breast cancer. J Drug Deliv. 2012;2012:915375. doi: 10.1155/2012/915375. Epub 2012 Apr 26.
- Results publication: PubMed 19786984Emadi A, Jones RJ, Brodsky RA. Cyclophosphamide and cancer: golden anniversary. Nat Rev Clin Oncol. 2009 Nov;6(11):638-47. doi: 10.1038/nrclinonc.2009.146. Epub 2009 Sep 29.
- Results publication: PubMed 17131349Inagaki M, Yoshikawa E, Matsuoka Y, Sugawara Y, Nakano T, Akechi T, Wada N, Imoto S, Murakami K, Uchitomi Y. Smaller regional volumes of brain gray and white matter demonstrated in breast cancer survivors exposed to adjuvant chemotherapy. Cancer. 2007 Jan 1;109(1):146-56. doi: 10.1002/cncr.22368.
- Results publication: PubMed 24777126Schultz C, Engelhardt M. Anatomy of the hippocampal formation. Front Neurol Neurosci. 2014;34:6-17. doi: 10.1159/000360925. Epub 2014 Apr 16.
- Results publication: PubMed 31651976Anderson JE, Trujillo M, McElroy T, Groves T, Alexander T, Kiffer F, Allen AR. Early Effects of Cyclophosphamide, Methotrexate, and 5-Fluorouracil on Neuronal Morphology and Hippocampal-Dependent Behavior in a Murine Model. Toxicol Sci. 2020 Jan 1;173(1):156-170. doi: 10.1093/toxsci/kfz213.
- Results publication: PubMed 33985854Yap NY, Toh YL, Tan CJ, Acharya MM, Chan A. Relationship between cytokines and brain-derived neurotrophic factor (BDNF) in trajectories of cancer-related cognitive impairment. Cytokine. 2021 Aug;144:155556. doi: 10.1016/j.cyto.2021.155556. Epub 2021 May 10.
- Results publication: PubMed 15135924Sommer C, Kress M. Recent findings on how proinflammatory cytokines cause pain: peripheral mechanisms in inflammatory and neuropathic hyperalgesia. Neurosci Lett. 2004 May 6;361(1-3):184-7. doi: 10.1016/j.neulet.2003.12.007.
- a full description of the MMSELink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Manal H El Hamamsy, Doctorate principal investigator
Ain Shams University - Faculty of Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alpha Lipoic Acid 600 MG Oral Capsule in people with Breast Cancer and Alpha Lipoic Acid, run by Ain Shams University at 1 site in Egypt.
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 8 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 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Shaimaa M Shaker, Pharmacist (+2001119894331 ext. +20, shaimaamohamed63@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor Necrotizing Factor Alpha Serum Levels (time frame: At baseline of treatment and After 12 weeks of the paclitaxel-based therapy (at the end of therapy)). 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 NCT06406127, which also lists 20 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 9 May 2024.