Effect of Alpha Lipoic Acid on Chemotherapy Induced Neurological Changes in Breast Cancer Patients

NCT06406127 | Recruiting Phase 4 DMC

• 1 other identifier: RHDIRB2020110301 REC #247
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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 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 \* Blood samples will be withdrawn 2 times (week 1 and week 12) to measure the following: (Stored in -80 C till the end of the study)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)

Conditions

Breast Cancer; Alpha Lipoic Acid; Paclitaxel; Neurologic Disorder; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (7)

• 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 - 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.

• 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 - 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.

Other Outcomes (3)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  through study completion, an average of 1 year.

• Monitoring the chemotherapy toxicity and side effects.

  through study completion, an average of 1 year.

• Monitoring Drug-Drug interactions.

  through study completion, an average of 1 year.

Study Arms (2)

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).

Drug: Alpha Lipoic Acid 600 MG Oral Capsule

Chemotherapy only

NO INTERVENTION

will receive chemotherapy only (paclitaxel for 12 weeks).

Interventions

Alpha Lipoic Acid 600 MG Oral Capsule DRUG

Single 600 mg daily dose

Also known as: No drug

Chemotherapy + Alpha Lipoic Acid

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead
• Dar EL Salam Cancer Hospital: collaborator

Study Sites (1)

Dar El Salam Cancer Hospital (Harmel Hospital)

Cairo, El Malek El Saleh, 11559, Egypt

RECRUITING

Related Publications (20)

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Related Links

• a full description of the MMSE

MeSH Terms

Conditions

Breast Neoplasms; Nervous System Diseases

Interventions

Thioctic Acid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Study Officials

• Manal H El Hamamsy, Doctorate

  Ain Shams University - Faculty of Pharmacy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shaimaa M Shaker, Pharmacist

CONTACT

+2001119894331; shaimaamohamed63@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacist

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: May 9, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)