Alpha-Lipoic Acid in Breast Cancer Patients
Atslēgvārdi
Abstrakts
Apraksts
Fifty breast cancer patients with stage from stage I to stage III will be involved in this study. Staging is done according to the American joint committee on cancer: TNM staging of breast cancer.
- All participants will be recruited from Ayadi AL-Mostakbal Oncology Center. The study will be approved by Research Ethics Committee of Damanhour University. All participants will give their consent.
- All 50 patients will be scheduled to receive 4 cycles of AC: cycled every 21 days followed by weekly cycle of taxol for 12 weeks.
Patients will be classified as follow:
- Group one: 25 patients will receive four cycles of AC followed by weekly taxol for 12 weeks.
- Group two: 25 patients will receive the same regimen as group 1 in addition to oral 600 mg alpha lipoic acid (ALA) once daily.
All patients will be submitted to:
1. Full patient history and clinical examination.
2. Venous blood will be collected before the first cycle of chemotherapy and after the last cycle of chemotherapy.
1- Cardio-toxcity assessment: i. Echo-cardiogram. ii. Troponin I. iii. The Brain Natriuretic Peptide (BNP). 2- Neurotoxicity assessment: i. National Cancer Institute common Terminology criteria for Adverse Effect grading: NCI-CTCAE version 4.0.
ii. Neurotoxicity questionnaire from the validated Functional Assessment of cancer therapy/gynecologic oncology group taxane specific neurotoxicity questionnaire: FACT-Taxane.
iii. MMP 3 a marker for neuropathic pain. iv. Neurotensin 3- Oxidative stress and inflammatory markers: i. Malondialdehyde (MDA). ii. TNF-alpha
Datumi
| Pēdējoreiz pārbaudīts: | 11/30/2019 |
| Pirmais iesniegtais: | 03/28/2019 |
| Paredzētā reģistrācija iesniegta: | 04/07/2019 |
| Pirmais izlikts: | 04/08/2019 |
| Pēdējais atjauninājums iesniegts: | 12/22/2019 |
| Pēdējā atjaunināšana ievietota: | 12/25/2019 |
| Faktiskais studiju sākuma datums: | 02/28/2019 |
| Paredzamais primārās pabeigšanas datums: | 11/30/2020 |
| Paredzamais pētījuma pabeigšanas datums: | 12/30/2020 |
Stāvoklis vai slimība
Iejaukšanās / ārstēšana
Dietary Supplement: Chemotherapy+alpha lipoic acid
Drug: Chemotherapy
Fāze
Roku grupas
| Roka | Iejaukšanās / ārstēšana |
|---|---|
| Experimental: Chemotherapy • Group one: 25 patients will receive four cycles of AC followed by weekly taxol for 12 weeks. | |
| Experimental: Chemotherapy+alpha lipoic acid • Group two: 25 patients will receive four cycles of AC followed by weekly taxol for 12 weeks. in addition to oral 600 mg alpha lipoic acid (ALA) once daily. | Dietary Supplement: Chemotherapy+alpha lipoic acid 600 mg Alpha-lipoic acid daily (an antioxidant that's in many foods, and it's made naturally in the investigator's bodies). |
Atbilstības kritēriji
| Vecums, kas piemērots studijām | 18 Years Uz 18 Years |
| Dzimumi, kas ir piemēroti studijām | Female |
| Pieņem veselīgus brīvprātīgos | Jā |
| Kritēriji | Inclusion Criteria: 1. All patients age ≥ 18 and < 70 years old with confirmed stage from stage I to stage III. 2. No evidence of metastases at initial assessment. 3. Patients has to have a good performance status (ECOG 0-2) according to Eastern Cooperative Oncology Group (ECOG) score. 4. Adequate baseline hematologic values (absolute neutrophilic count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, and hemoglobin level ≥ 10g/dL). 5. Patients with adequate liver function (serum creatinine < 1.5 mg/dL) and adequate renal function (serum creatinine < 1.5 mg/dL, creatinine clearance (CrCl) > 45 ml/min). 6. Either pre operative or post operative chemotherapy are allowed. Exclusion Criteria: 1. Evidence of metastases at initial assessment. 2. Pregnancy or breast-feeding patients. 3. Prior exposure to neurotoxic chemotherapy was not allowed (no carboplatin, vincristine, vinblastine, paclitaxel, or docetaxol ) for 6 months prior study treatment. 4. Clinical evidence of serious cardiac illness (myocardial dysfunctional, angina pectoris requiring anti-angina medication, poorly controlled hypertension, and uncontrolled arrhythmias). 5. Patients with a reduced cardiac output with a left ventricular ejection fraction (LVEF) ejection fraction < 50%. 6. Patients who had evidence of pre-existing peripheral neuropathy resulting from another reason (diabetes). 7. Patients with a history of allergy to alpha-lipoic acid. 8. Concomitant use of multivitamins (vitamin E), opioids, anticonvulsants, tricyclic antidepressants, other neuropathic pain medication modifying agents (e.g., gabapentin, lamotrigine, carbamazepine, phenytoin, or tricyclic antidepressants) are not allowed |
Rezultāts
Primārie rezultāti
1. Cardiotoxcity assessment [three months]
2. Neurotoxicity assessment [three months]
3. oxidative stress and inflammatory markers [three months]
