Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Other Dietary Supplements

Vitamins

Paclitaxel

Albumin-Bound Paclitaxel

Thioctic Acid

Antioxidants

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Alpha-lipoic Acid

Folate

Vitamin B9

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).

will receive chemotherapy only (paclitaxel for 12 weeks).

Alpha Lipoic Acid 600 MG Oral Capsule

Shaimaa M Shaker, Pharmacist

Loay M Kassem, Physician

Manal H El Hamamsy, Doctorate

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  \* Blood samples will be withdrawn 2 times (week 1 and week 12) to measure the following: (Stored in -80 C till the end of the study)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

* 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.

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

Monitoring alpha lipoic acid related adverse reactions:

Headache, heartburn, nausea and vomiting are nearly the most common adverse effects concerning alpha lipoic acid.

National Cancer Institute common Terminology criteria for Adverse Effect grading: NCI-CTCAE version 4.0. for evaluation of chemotherapy toxicities.

Including chemotherapeutic agents and any other add-on medication.

All patients will be evaluated during the trial for 2 times via monitoring the Tumor Necrotizing Factor- alpha (TNF-α).

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.

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.

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.

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.

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.

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.

All patients will be evaluated during the trial for 2 times via monitoring Brain-Derived Neurotrophic Factor (BDNF) serum levels.

Dar EL Salam Cancer Hospital

Ain Shams University

Pharmacist

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Polycystic Ovary Syndrome

Primary Ovarian Insufficiency

Menopause, Premature

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Vasodilator Agents

Platelet Aggregation Inhibitors

Anticoagulants

Reproductive Control Agents

Pentoxifylline

Citric Acid

Sodium Citrate

Clomiphene

Enclomiphene

Zuclomiphene

Phosphodiesterase Inhibitors

Enzyme Inhibitors

Radiation-Protective Agents

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Estrogen Receptor Modulators

Selective Estrogen Receptor Modulators

Citrate

ALA is sold as a dietary supplement, either by itself or incorporated into a multivitamin product. it also has anti-oxidant effect.

Alpha lipoic acid (ALA)

Pentoxifylline is a methylxanthine derivative which acts as a vasodilator by increasing blood flow to tissues, inhibits inflammatory responses, and reduces blood viscosity by impeding platelet aggregation

Pentoxifylline (PTX)

is a medication used to treat infertility in women who do not ovulate

Clomiphene Citrate

Nagwa Al Sabri, Phd

This study evaluate the addition of PTX and ALA to clomiphene citrate in the treatment of polycystic ovary.

Clomiphene, PTX and ALA each used in treatment of pco but they do so by different mechanisms.

Clomifene is in the selective estrogen receptor modulator (SERM) family of medication. It works by causing the release of gonadotropin-releasing hormone by the hypothalamus, and subsequently gonadotropin from the anterior pituitary.

PTX and ALA are used in treatment of pco due its anti-oxidant effect.

prospective randomized controlled open label study

Efficacy of Pentoxifylline and Alpha Lipoic Acid in PCOS Resistant to Clomiphene Citrate

Evaluation of the Effect of Pentoxifylline and α-Lipoic Acid as Adjunctive Therapy in Patients With Clomiphene Citrate Resistant Polycystic Ovary Syndrome

Follicles measure more than 18 mm will be considered mature follicles.

Misr University for Science and Technology

principal investigator

Nutritional and Metabolic Diseases

Insulin Resistance

Hyperinsulinism

Metabolic Diseases

Glucose Metabolism Disorders

Hypoglycemic Agents

Insulin

Insulin, Globin Zinc

Alpha Lipoic Acid

Umesh Masharani, MD

Ira Goldfine, MD

The study will recruit 40 subjects with Polycystic Ovary Syndrome (PCOS) as defined by the NIH criteria. The subjects will be pre-screened for insulin sensitivity using fasting insulin and glucose levels and oral glucose tolerance test. The 20 most insulin resistant subjects will undergo measurements of in vivo insulin action by hyperinsulinemic, euglycemic clamp. Body composition will be measured by dual-energy X-ray absorptiometry (DEXA). Plasma lipids and markers of oxidative stress will be measured. They will then receive open label controlled release alpha lipoic acid (CRLA) at 800 mg twice daily for 16 weeks. After treatment hyperinsulinemic euglycemic clamps, DEXA, plasma lipids and markers of oxidative stress will be repeated.

Hypotheses: LA will improve insulin sensitivity in PCOS subjects; LA will reduce oxidative stress, testosterone levels and improve cardiovascular risk factors.

Insulin resistance commonly occurs in patients with Polycystic Ovary Syndrome (PCOS) and may be responsible for many of the long term complications of PCOS. Patients with PCOS are at increased risk for developing type 2 diabetes and the metabolic syndrome (hypertension, dyslipidemia and cardiovascular disease). Data suggest that oxidative stress contributes to insulin resistance and thus inhibitors of oxidative stress improve insulin action. Alpha Lipoic Acid (LA) is synthesized in the liver and other tissues and is a key component of several mitochondrial enzyme complexes responsible for oxidative glucose metabolism and cellular energy production. When used pharmacologically, LA functions as a safe and effective antioxidant, recycling vitamins C and E,elevating glutathione levels,and lowering reactive oxygen species. Cell culture studies reveal that LA reverses the effects of oxidative stress and improving insulin action. Preliminary clinical data indicate that antioxidants may improve insulin resistance in PCOS patients. We propose, therefore, to study LA's effects on insulin-stimulated glucose uptake (insulin clamp) in a well characterized population of insulin resistant PCOS patients. Because these patients usually present in the adolescent and teenage years, the development of safe, long-term, treatment strategies are needed.

Alpha Lipoic Acid and Polycystic Ovary Syndrome

National Institutes of Health (NIH)

University of California, San Francisco

Mouth and Tooth Diseases

Digestive System Diseases

Head and Neck Neoplasms

Stomatitis

Mucositis

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Respiratory System Agents

Nitric Oxide

35 patients will receive radiation therapy with or without platinum-based chemotherapy in addition to alpha lipoic acid 600 mg tablets twice daily (throughout the radiotherapy period). .

35 Patients will receive radiation therapy with or without platinum-based chemotherapy in addition to placebo tablets twice daily (throughout the radiotherapy period)

Alpha Lipoic Acid (ALA) is a drug which has been used in treatment of diabetic neuropathy . It act through enhancing nitric oxide-mediated endothelium-dependent vasodilation, thus improving microcirculation in patients with diabetic polyneuropathy. It is considered a safe drug, generally with a daily dose of 200 to 2400 mg/day is considered tolerable without significant side effects. Only gastrointestinal tracts side effects like nausea, vomiting, dyspepsia and abdominal pain have been described in some clinical trials. Also FDA experts confirm its safety and efficacy in humans

Alpha Lipoic Acid 600 MG Oral Tablets

placebo tablets of the same generic of active drug which contain all the same ingredients as active tablets except alpha lipoic acid

Placebo tablets

radiation or concurrent radiotherapy plus platinum-based chemotherapy

radiation or concurrent chemoradiation

Bishoy Anwar Rizk-Allah, bachelor

A prospective, randomized, controlled, single-blinded study will be conducted at Clinical Oncology department, Ain Shams University Hospitals, assessing the effect of Alpha Lipoic Acid on the incidence and severity of radiotherapy induced oral mucositis in Head and Neck cancer patients.

All patients presenting to the Clinical Oncology department, Ain Shams University Hospitals, will be assessed for eligibility as follow:

Inclusion criteria:

* Age \>18 years.
* Diagnosis of stage I, II, III or IV squamous cell carcinoma, nasopharyngeal carcinoma.
* Measurable disease on CT scan at baseline.
* Planned to receive radiotherapy with a total dose 60 grays or more divided on 30 fractions with or without cisplatin (100 mg/m2, administered intravenously every 21 days for three cycles or 40 mg/m2 administered weekly for up to 7 weeks).
* Adequate liver function (liver transaminases level \< 3 times upper normal limits and total bilirubin \< 1.5 times upper normal limits).
* Adequate kidney function (estimated glomerular filtration rate \>60 ml/min).
* Adequate bone marrow function (WBCs count \> 3000 cells/mm3, ANC count \>1500 cells/mm3 and platelets count \> 100,000 cells/mm3).

Exclusion criteria:

Patients will be excluded if they have any of the following:

* Diagnosis of Thyroid cancer.
* Presence of other primary cancers.
* Treatment with alpha lipoic acid for any other indication.
* Allergy to alpha lipoic acid.
* Pregnant or lactating women. Eligible patients will be randomized to either... Alpha Lipoic Acid Group (intervention group): 35 patients will receive radiation therapy with or without platinum-based chemotherapy in addition to alpha lipoic acid 600 mg tablets twice daily (throughout the radiotherapy period). The medication will be brought from EVA company ( an Egyptian drug company ) under the trade name of thiotacid 600 mg tablets.

Control Group: 35 Patients will receive radiation therapy with or without platinum-based chemotherapy plus placebo tablets of thiotacid throughout the radiation period

All patients will be followed up weekly to assess the incidence and severity of radiation induced oral mucositis using the radiotherapy oncology group criteria also blood samples will be drawn at baseline , after three weeks (middle of radiation period) at the end of radiation period to asses changes in CRP and TAC levels

A prospective, randomized, controlled, single blinded study

The Effect of Alpha Lipoic Acid on the Incidence and Severity of Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients

The patients will be followed up during the whole period of radiation and up to six weeks after radiation to evaluate the incidence and severity of radiation induced mucositis. Severity will be assessed by the oncologist using radiotherapy oncology group criteria (RTOG criteria)

For each patient, the time from the start of radiotherapy till the development of grade III or IV RIOM will be recorded.

Pain

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Stage II-IVB HNSCC patients receiving concurrent systemic therapy and radiation as standard of care will receive ALA before, during, and after treatment. The drug will have dose escalation in a 3+3 design. The first group of 3 patients will receive 600 mg twice a day. If there are no DLTs, the next 3 patients will receive the highest dose of 600 mg three times a day. If one or more patients develop a DLT at any of the dosing levels, the group will either be expanded or dropped to a lower dose level.

Stage II-IVB HNSCC patients receiving concurrent systemic therapy and radiation in the definitive, adjuvant, or palliative setting will receive ALA according to their prescribed dose level. ALA will be taken orally or per feeding tube. It will start 1 week prior to the start of CRT, continue on through CRT, and then continue for 2 weeks after the completion of CRT. Patients will be given dosing diaries to document date and time of each drug administration as well as any missed doses. They will also have weekly visits to report AEs and concurrent medications, have a history and physical exam, report VAS pain scores and OMAS scores, and fill FACT-HN surveys.

Jessica McDermott

This is a phase I, single-center, non-randomized, 3+3 dose-escalation study of alpha lipoic acid given during chemotherapy-radiation in HNSCC patients with non-metastatic disease.

The study will be completed when the MTD and RP2D are determined. This will be either when 2 or more patients have a DLT at a particular dose level, or when 6 patients have completed treatment at the highest dose level (600 mg TID). The final 3 patients enrolled at the highest tolerated dose will also complete PK studies.

3+3 Dose Escalation: Dose Level -2: ALA 300 mg daily Dose Level -1: ALA 600 mg daily Dose Level 1: ALA 600 mg BID Dose Level 2: ALA 600 mg TID

Alpha Lipoic Acid to Decrease Pain and Side Effects in Concurrent Treatment of HNSCC

Alpha Lipoic Acid to Decrease Treatment Related Pain and Side Effects During Concurrent Chemoradiation in HNSCC

The maximum tolerated dose will be the highest dose in the planned schema that is given without evidence of SAEs.

The RP2D will incorporate the MTD and PKs to determine the dose that is best tolerated as well as has the concentration necessary to be effective according to historical studies.

Adverse events will be documented to determine the primary endpoints as well as to categorize potential side effects that can be attributed to ALA. CTCAE version 5.0 will be used to categorize the AEs

Maximum plasma concentration will be evaluated on the 3 patients in the dose expansion group at the MTD. This will be studied when given with cisplatin for standardization to ensure concentration is similar to when ALA is given alone.

OMAS scores will give preliminary measures on efficacy of drug to control pain and improve quality of life which will be the primary focus in future studies. Total scores will be collected from 0 (no mucositis) to 45 (worse mucositis). Average OMAS and change from baseline to worst score will be evaluated.

VAS for pain will give preliminary measures on efficacy of drug to control pain which will be the primary focus in future studies. The VAS score is from 0-10 with 0 being no pain and 10 being the worse possible pain. Average VAS and change from baseline to worst score will be evaluated.

The Functional Assessment of Cancer Therapy - Head \& Neck (FACT-HN) will be used to evaluate quality of life measures at baseline and during treatment. This scale has the sub-categories of physical well being, social/family well-being, emotional well-being, functional well-being, and additional concerns. Each question is scaled from 0 (worst) to 4 (best). Each sub-category will be totaled and a total FACT-HN score will be calculated for each time point. Average sub-category and total scores will be calculated as well as change from baseline to worst scores during treatment.

Patients will document every dose of opioid medications taken during the study period. This will be used to used to calculated total opioid amounts taken (as oxycodone equivalents) as well as total duration of opioid use in days.

Progression free survival will be calculated as time to disease progression from start of treatment measured in weeks. This will be documented by PET/CT and/or CT neck and chest completed prior to start of treatment and approximately 3 and 6 months after treatment discontinuation

OS will be calculated as time from start of treatment to death as measured in weeks. This will be documented by survival follow-up during study visits

Cancer League of Colorado

University of Colorado, Denver

Infertility

Infertility, Female

Anti-Inflammatory Agents

Androgens

Letrozole

Follicle Stimulating Hormone

Aromatase Inhibitors

Chorionic Gonadotropin

This group will include 75 PCOS participants who will receive the standard treatment letrozole and the other commonly provided PCOS care (lifestyle modification, diet and exercise education, any other non-pharmacological method of management) according to the PCOS guidelines .Treatment with letrozole will begin after the baseline visit and for three cycles.

this will include 75 PCOS participants who will receive the standard treatment as letrozole with the same schedule of the control group and the other commonly provided PCOS care as previously described in addition to ALA, (Thiotacid®, EVAPHARMA, Egypt) in a dose of one tablet "600 mg" three times per day Each patient in the test group will start the ALA from day 3 of the menstrual period then daily until the day of human chorionic gonadotropin (HCG) injection

Alpha-lipoic acid (ALA), also known as 1,2-dithiolane-3-pentanoic acid or thioctic acid, is found in the mitochondria. It acts as an enzymatic cofactor for various enzymes in the Kreb's cycle. ALA has many beneficial properties making it a potential candidate for various clinical disorders. It is considered the universal or "ideal" antioxidant as it is both water-soluble and fat-soluble facilitating its passage across membran. ALA has direct as well as indirect anti-inflammatory effects. Being a potent antioxidant leads to a reduction in oxidative stress which in turn reduces inflammation, meaning ALA indirectly has anti-inflammatory effects. To add to ALA's benefits, it has anti-inflammatory properties that are independent of its antioxidant effects.

Alpha lipoic acid

Letrozole is an aromatase inhibitor that controls the conversion of androgen to estrogen and increases ovarian androgens. The administration of letrozole in the follicular phase removes the effect of negative estrogen feedback on the pituitary and hypothalamus, thus increasing the gonadotropins\]. When Letrozole blocks estrogen production, it encourages the body to produce more follicle-stimulating hormone (FSH).The additional FSH stimulates egg development and increases the likelihood of ovulation. Kar, S. Found that letrozole has excellent pregnancy rates compared to clomiphene citrate, Letrozole should be considered at par with clomiphene citrate as first-line drug for ovulation induction in infertile PCOS women.

Muoaz A. Sallam, Teaching assistance

Sara M. Zaki, Professor

Marwa A. Ahmed, Professor

This research study aims to investigate the effect of adding Alpha lipoic acid (ALA) supplement to letrozole treatment in infertile women with polycystic ovary syndrome (PCOS). The study will include 150 PCOS participants seeking fertility treatment. They will be randomly divided into two groups - control and intervention. Both groups will receive standard PCOS care including lifestyle counseling. The control group will be treated with letrozole only. The dose will start at (2.5 mg) for 5 days and can increase up to (7.5 mg) based on response. The intervention group will take ALA supplements along with letrozole treatment. ALA tablets (600mg) will be given three times daily starting from day 3 of the menstrual cycle till human chorionic gonadotropin (HCG) injection day. Letrozole dose for the intervention group will also follow the same incremental protocol as the control group. Patient monitoring will involve trans-vaginal ultrasound scans on certain cycle days to check follicle growth and the thickness of uterus lining. Once a follicle reaches 18mm in size, an intramuscular HCG injection will be given. Couples will be asked to have intercourse 36 hours after the injection.

Pregnancy will be tested two weeks later if menstruation does not occur. Metabolic, hormonal, and ultrasound parameters will be recorded at baseline and follow-ups. All adverse effects of the treatment will be noted. The study period will be a maximum of 3 treatment cycles or untill pregnancy is achieved. Outcome measures include ovulation and pregnancy rates. The effect of ALA on metabolic parameters (fasting glucose, fasting insulin, BMI and HOMA-IR), hormone levels (mid-luteal progesterone and serum estradiol), and follicular growth will also be assessed. Proper sample size and randomization methods will be followed. A Statistical analysis of collected data will help determine if ALA has additional benefits when combined with letrozole for PCOS fertility treatment. Finally, the results will be statistically analyzed. Statistical analysis will be done using the SPSS statistical software package.

Eligible participants will be randomly allocated to the control group or the intervention group with a ratio of 1:1 after obtaining informed consent.

The two study groups will be as follows:

Control group: this group will include 75 PCOS participants who will receive the standard treatment letrozole and the other commonly provided PCOS care (lifestyle modification, diet and exercise education, any other non-pharmacological method of management) according to the PCOS guidelines.

Treatment with letrozole will begin after the baseline visit, and for three cycles, the administration will start after a spontaneous or progesterone-induced menstruation. In the first cycle, "2.5" mg letrozole will be taken for 5 days starting from day 3 to 7 of the menses, if no pregnancy was detected, letrozole dose will be increased to "5 mg" in the next cycle, and finally, "7.5 mg" letrozole will be administered during the third cycle if the patient is still unable to conceive.

Interventional group: this will include 75 PCOS participants who will receive the standard treatment as letrozole with the same schedule as the control group and the other commonly provided PCOS care as previously described in addition to ALA, (Thiotacid®, EVAPHARMA, Egypt) in a dose of one tablet "600 mg" three times per day Each patient in the test group will start the ALA from day 3 of the menstrual period, then daily until the day of human chorionic gonadotropin (HCG) injection.

Baseline assessment:

After enrollment, baseline data and demographics will be obtained from each participant including:

* Age and body mass index will be calculated in Kg/m\^2.
* Serum FSH, LH, TSH, prolactin, androgens, including free and total testosterone and SHBG.
* Ultrasound measurements including antral-follicles count and detection of Polycystic ovaries "defined as either 12 or more follicles measuring 2 to 9 mm in diameter or an increased ovarian volume \>10 cm\^3.".
* Menstrual cyclicity, presence of first degree relatives with diabetes mellitus , smoking status, comorbidities, medication history .
* All subjects will be educated about their diet and physical activity, and they will be asked not to start any new medications during the study without informing the principal investigator.

Patients monitoring and follow-up. All the participants included in the study after a spontaneous or progesterone-induced menstrual cycle will be randomly assigned to either Control group or Interventional group and will be monitored by trans-vaginal ultrasound to assess follicular diameter and endometrial thickness on the 10th day of the cycle, then on 12th , 14th and the 20th days of the cycle for assessment of dominant follicle ( ≥ 18 mm) on TVUS. The number of dominant follicles and the endometrial thickness will be documented for each menstrual cycle.

* When at least one dominant follicle is detected, participants will receive an intramuscular injection of 10 000 IU human chorionic gonadotropin (HCG) (Choriomon, IBSA).
* An HCG injection will be given when at least one follicle measuring at least 18 mm is observed.
* Ovulation will also be confirmed by the evaluation of serum progesterone each cycle between cycle days 20-22 ( \> 5 ng/mL) and the test will be repeated 1 week later if the initial progesterone level is below the threshold to confirm ovulation.
* Couples will be instructed to have timed intercourse 36 hours after the HCG injection.
* Serum HCG will be determined 2 weeks after HCG injection in the absence of menstruation for the detection of pregnancy.
* Pregnant women will be required to stop all medication.
* Patients who do not have any dominant follicles, will start a new ovulation induction cycle in the following month.
* Treatment of the next cycle will start if menses occurs either spontaneously or by induction. The first day of the menses is considered the first day of the cycle and this is repeated for up to a total of 3 treatment cycles.
* For those who fail to achieve a dominant follicle, alpha lipoic acid will be stopped and restarted in the next cycle as before.

Effect of ALA Combined With Letrozole on Polycystic Ovary Syndrome Clinical Outcome in Infertile Females

Effect of Alpha-Lipoic Acid Supplementation on Polycystic Ovary Syndrome Clinical Outcome in Infertile Females Treated With Letrozole

which is defined as the proportion of cycles in which ovulation occurred in the whole follow-up period.

ultrasound visualization of one or more gestational sac with pulsating fetal pole

weight in kilograms, height in meters will be combined to report BMI in kg/m\^2

fasting insulin in (microU/L), fasting glucose in (nmol/L) will be combined to report HOMA-IR

Number of mature follicles in each ovary.

Nervous System Diseases

Peripheral Nervous System Diseases

Neuromuscular Diseases

Oral administration three times daily (morning, mid-day, night)

The baseline dose is 100 mg three times daily for four months. Dose escalation will occur until a maximum tolerated dose is found.

Jeffrey A. Allen, MD

This study is being done because peripheral neuropathy, a condition that interrupts sensation in your limbs, is a common side effect of paclitaxel. There is some evidence that alpha lipoic acid (ALA), an antioxidant compound, protects neurons after exposure to paclitaxel. The purpose of this study is to assess the safety and tolerability of ALA and to find the best dose of ALA in patients that receive chemotherapy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Alpha Lipoic Acid on Chemotherapy Induced Neurological Changes in Breast Cancer Patients	NCT06406127	Breast Cancer Alpha Lipoic Ac... Paclitaxel Neurologic Diso... Chemotherapy	Alpha Lipoic Ac...	18 Years - 75 Years	Ain Shams University
Efficacy of Pentoxifylline and Alpha Lipoic Acid in PCOS Resistant to Clomiphene Citrate	NCT05231980	Clomiphene Citr... Resistant Ovary... Polycystic Ovar...	Alpha lipoic ac... Pentoxifylline ... Clomiphene Citr...	18 Years - 39 Years	Ain Shams University
Alpha Lipoic Acid and Polycystic Ovary Syndrome	NCT00505427	Insulin Resista... Oxidative Stres...	Alpha Lipoic Ac...	18 Years - 50 Years	University of California, San Francisco
The Effect of Alpha Lipoic Acid on the Incidence and Severity of Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients	NCT05023863	Radiation-Induc...	Alpha Lipoic Ac... Placebo tablets radiation or co...	18 Years - 70 Years	Ain Shams University
Alpha Lipoic Acid to Decrease Pain and Side Effects in Concurrent Treatment of HNSCC	NCT04042935	HNSCC	Alpha Lipoic Ac...	18 Years - 100 Years	University of Colorado, Denver
Effect of ALA Combined With Letrozole on Polycystic Ovary Syndrome Clinical Outcome in Infertile Females	NCT06418347	Polycystic Ovar... Infertility, Fe...	Alpha lipoic ac... Letrozole	18 Years - 35 Years	Ain Shams University
Alpha Lipoic Acid to Decrease Pain and Side Effects in Concurrent Treatment of HNSCC	NCT04042935	HNSCC	Alpha Lipoic Ac...	18 Years - 100 Years	University of Colorado, Denver
Alpha-lipoic Acid in Patients at Risk for Paclitaxel Induced Neuropathy	NCT01313117	Peripheral Neur...	Alpha lipoic ac...	18 Years -	Northwestern University
The Effect of Alpha Lipoic Acid on the Incidence and Severity of Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients	NCT05023863	Radiation-Induc...	Alpha Lipoic Ac... Placebo tablets radiation or co...	18 Years - 70 Years	Ain Shams University
Alpha-lipoic Acid in Patients at Risk for Paclitaxel Induced Neuropathy	NCT01313117	Peripheral Neur...	Alpha lipoic ac...	18 Years -	Northwestern University
Efficacy of Pentoxifylline and Alpha Lipoic Acid in PCOS Resistant to Clomiphene Citrate	NCT05231980	Clomiphene Citr... Resistant Ovary... Polycystic Ovar...	Alpha lipoic ac... Pentoxifylline ... Clomiphene Citr...	18 Years - 39 Years	Ain Shams University

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