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| Name | Class |
|---|---|
| Dar EL Salam Cancer Hospital | UNKNOWN |
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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* Blood samples will be withdrawn 2 times (week 1 and week 12) to measure the following: (Stored in -80 C till the end of the study)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)
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:
Throughout the treatment process, both groups will be monitored for any side effects concerning the alpha lipoic acid or the chemotherapeutic regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Chemotherapy only | No Intervention | will receive chemotherapy only (paclitaxel for 12 weeks). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alpha Lipoic Acid 600 MG Oral Capsule | Drug | Single 600 mg daily dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At baseline of treatment and After 12 weeks of the paclitaxel-based therapy (at the end of therapy) |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
The scale of numbers of the answers is:
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Monitoring alpha lipoic acid related adverse reactions: Headache, heartburn, nausea and vomiting are nearly the most common adverse effects concerning alpha lipoic acid. | through study completion, an average of 1 year. |
| Monitoring the chemotherapy toxicity and side effects. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shaimaa M Shaker, Pharmacist | Contact | +2001119894331 | +20 | shaimaamohamed63@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Manal H El Hamamsy, Doctorate | Ain Shams University - Faculty of Pharmacy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dar El Salam Cancer Hospital (Harmel Hospital) | Recruiting | Cairo | El Malek El Saleh | 11559 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30264707 | Result | 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. | |
| 36382727 | Result | Rostom 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. |
| Label | URL |
|---|---|
| a full description of the MMSE | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009422 | Nervous System Diseases |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D008063 | Thioctic Acid |
| ID | Term |
|---|---|
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| 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:
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. | 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:
| 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. | 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. | 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. | 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. | At baseline and After 12 weeks of the paclitaxel-based therapy (at the end of therapy) |
National Cancer Institute common Terminology criteria for Adverse Effect grading: NCI-CTCAE version 4.0. for evaluation of chemotherapy toxicities. |
| through study completion, an average of 1 year. |
| Monitoring Drug-Drug interactions. | Including chemotherapeutic agents and any other add-on medication. | through study completion, an average of 1 year. |
| 33705788 | Result | Brown 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. |
| 32554133 | Result | Bellens 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. |
| 21600374 | Result | Janelsins 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. |
| 22619725 | Result | Lee 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. |
| 19786984 | Result | Emadi 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. |
| 17131349 | Result | Inagaki 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. |
| 24777126 | Result | Schultz C, Engelhardt M. Anatomy of the hippocampal formation. Front Neurol Neurosci. 2014;34:6-17. doi: 10.1159/000360925. Epub 2014 Apr 16. |
| 31651976 | Result | Anderson 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. |
| 33985854 | Result | Yap 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. |
| 15135924 | Result | Sommer 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. |
| 35596774 | Result | Werida 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. |
| 21073761 | Result | Odabasoglu 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. |
| 9378235 | Result | Biewenga 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. |
| 30721699 | Result | Haghighatdoost F, Hariri M. The effect of alpha-lipoic acid on inflammatory mediators: a systematic review and meta-analysis on randomized clinical trials. Eur J Pharmacol. 2019 Apr 15;849:115-123. doi: 10.1016/j.ejphar.2019.01.065. Epub 2019 Feb 2. |
| 12457622 | Result | Al-Majed AA, Gdo AM, Al-Shabanah OA, Mansour MA. Alpha-lipoic acid ameliorates myocardial toxicity induced by doxorubicin. Pharmacol Res. 2002 Dec;46(6):499-503. doi: 10.1016/s1043661802002311. |
| 35510329 | Result | Aliomrani M, Mesripour A, Mehrjardi AS. Creatine and Alpha-Lipoic Acid Antidepressant-Like Effect Following Cyclosporine A Administration. Turk J Pharm Sci. 2022 Apr 29;19(2):196-201. doi: 10.4274/tjps.galenos.2021.27217. |
| 29291932 | Result | Costa DSJ, Loh V, Birney DP, Dhillon HM, Fardell JE, Gessler D, Vardy JL. The Structure of the FACT-Cog v3 in Cancer Patients, Students, and Older Adults. J Pain Symptom Manage. 2018 Apr;55(4):1173-1178. doi: 10.1016/j.jpainsymman.2017.12.486. Epub 2017 Dec 30. |
| 34562992 | Result | Limpawattana P, Manjavong M. The Mini-Cog, Clock Drawing Test, and Three-Item Recall Test: Rapid Cognitive Screening Tools with Comparable Performance in Detecting Mild NCD in Older Patients. Geriatrics (Basel). 2021 Sep 16;6(3):91. doi: 10.3390/geriatrics6030091. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D003067 |
| Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D005227 | Fatty Acids |
| D008055 | Lipids |