Nutraceuticals Versus Usual Care in the Prevention or Reduction of CIPN in Patients Treated With Docetaxel as Neoadjuvant/Adjuvant Breast Cancer Therapy

AHS Cancer Control Alberta

Status and phase: Terminated; Phase 2

Conditions: Peripheral Neuropathy in Breast Cancer Patient

Treatments: Dietary Supplement: Vitamin D; Dietary Supplement: Vitamin B6; Dietary Supplement: Omega-3 Fatty Acids; Dietary Supplement: Vitamin B12

Study type: Interventional

Funder types: Other

Identifiers

NCT02795572

CIPNN-SMG-CCI-01

Details and patient eligibility

About

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).

Full description

Phase 2, Single Centre, Open-label 2 Arm Randomized Trial. The intervention group will receive a daily dose of Vitamin D, Omega-3-fatty acids, Vitamin B6, and Vitamin B12. The reference group will have usual care.

Dose of Nutraceuticals: Vitamin D 2000 IU 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 (600 mg EPA, 300 mg DHA)

Population: Breast Cancer patients undergoing either neoadjuvant or adjuvant therapy with docetaxel.

106 participants in total will be needed with accrual being completed in hopefully 1 years' time. Study Investigators will screen the candidates for the study.

Enrollment: 13 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Intervention Group

Experimental 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 \[900 mg TID (600 mg EPA, 300 mg DHA)\].

Treatment:

Dietary Supplement: Omega-3 Fatty Acids

Dietary Supplement: Vitamin B6

Dietary Supplement: Vitamin D

Dietary Supplement: Vitamin B12

Reference Group

No Intervention group

Description:

Reference group will receive usual care.