Clinical trial · Interventional
Nutraceuticals Versus Usual Care in the Prevention or Reduction of CIPN in Patients Treated With Docetaxel as Neoadjuvant/Adjuvant Breast Cancer Therapy
Protocol Comparing a Nutraceutical Formulation Consisting of Omega-3 Fatty Acids, Vitamin D, and Vitamins B6 Plus B12 Versus No Treatment in the Prevention or Reduction of Chemotherapy Induced Peripheral Neuropathy (CIPN) in Patients Treated With Docetaxel as Neoadjuvant/Adjuvant Breast Cancer Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Retirement of the Principal Investigator
Summary
Brief summary (as posted)
The trial will utilize Nutraceuticals (Vitamin D 2000IU oral once daily, Vitamin B6 100 mg oral once daily, Vitamin B12 100 mcg oral once daily, Omega-3 Fatty Acids 900 mg oral three times a day) in patients treated with Docetacel as Neoadjuvant or Adjuvant Breast cancer Therapy. The trial is being conducted to see if the use of Nutraceuticals will prevent or reduce Chemotherapy Induced Peripheral Neuropathy (CIPN).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peripheral Neuropathy in Breast Cancer Patient | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Omega-3 Fatty Acids | Dietary Supplement | — | UNRESOLVED |
| Vitamin B12 | Dietary Supplement | — | UNRESOLVED |
| Vitamin B6 | Dietary Supplement | — | UNRESOLVED |
| Vitamin D | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention Group
- description
- The intervention group will receive a daily dose of Vitamin D 2000 IU, Vitamin B6 100 mg, Vitamin B12 100 mcg and Omega-3 Fatty Acids 2700 mg \[900 mg TID (600 mg EPA, 300 mg DHA)\].
- interventionNames
- Dietary Supplement: Vitamin D
- Dietary Supplement: Vitamin B6
- Dietary Supplement: Vitamin B12
- Dietary Supplement: Omega-3 Fatty Acids
- type
- NO_INTERVENTION
- label
- Reference Group
- description
- Reference group will receive usual care.
Primary outcomes (1)
- measure
- Chemotherapy Induced Peripheral Neuropathy Assessment
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Female 18-70 years of age * Biopsy proven invasive breast carcinoma * Scheduled to receive docetaxel (3-6 cycles) * Have values for liver (AST, ALT, Bilirubin) and renal function (CREAT), within 1.5 times normal values as drawn per standard of care. * ECOG 0-2 * Be able to provide informed consent * Willingness to adhere to regimen Exclusion Criteria: * Metastatic disease * Any peripheral neuropathy * Known HIV (testing not required) * Diseases causing malabsorption i.e.: Inflammatory Bowel Disease, Celiac and Whipple's Disease * Patients with seafood allergies * Patients on Warfarin or with a documented clinically significant bleeding disorder
References
Publications (0)
Data not yet available