Effect of Alpha Lipoic Acid on Chemotherapy Induced Neurological Changes in Breast Cancer Patients
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Tumor Necrotizing Factor Alpha Serum Levels
研究概览
简要总结
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* Blood samples will be withdrawn 2 times (week 1 and week 12) to measure the following: (Stored in -80 C till the end of the study)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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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 -
- •Patient Health Questionnaire (PHQ) score from 0 - 9.
排除标准
- •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.
研究组 & 干预措施
Chemotherapy + Alpha Lipoic Acid
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).
干预措施: Alpha Lipoic Acid 600 MG Oral Capsule (Drug)
结局指标
主要结局
Tumor Necrotizing Factor Alpha Serum Levels
时间窗: 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).
次要结局
- Response assessment by questionnaire - FACT-COG Test(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)(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(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(At baseline and After 12 weeks of the paclitaxel-based therapy (at the end of therapy))
- Response assessment by questionnaire - Mini Mental State Examination (MMSE)(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)(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)(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.)
研究者
Shaimaa Mohamed SafaaElDin
Pharmacist
Ain Shams University