Participants will take 11 capsules per day containing DHA-enriched triglyceride oil (1 g capsules containing at least 400 mg DHA) for a total of 5 g DHA/day divided into three times daily with meals or as tolerated.

Participants will take 11 capsules per day containing corn/soy oil blend capsules divided into three times daily with meals or as tolerated.

Breast Cancer

Participants will take 11 capsules of DHA oil for 12-18 weeks (84-126 days), beginning on day 1 of initial cycle of chemotherapy, and continuing for 4-6 cycles of chemotherapy prior to definitive breast surgery. Study will end when subject undergoes breast surgery.

Docosahexaenoic acid (DHA)

Participants will take 11 capsules of placebo (corn/soy oil blend) for 12-18 weeks (84-126 days), beginning on day 1 of initial cycle of chemotherapy, and continuing for 4-6 cycles of chemotherapy prior to definitive breast surgery. Study will end when subject undergoes breast surgery.

Placebo oral capsule

Cross Cancer Institute

Docosahexaenoic Acid (DHA) for Women With Breast Cancer in the Neoadjuvant Setting

Ki67 will be measured by image analysis at baseline biopsy and at experimental end (surgical excision).

Changes in level of DHA incorporation in plasma phospholipids will be assessed to identify the range of DHA incorporation in this patient population. Fatty acid composition of plasma phospholipids will be measured after lipid extraction, phospholipid separation on thin layer chromatography followed by methylation and separation identification by gas-liquid chromatography.

Systemic immune function will be assessed on stored plasma by U-PLEX Biomarker Group 1 electrochemiluminescent multiplex assays (MesoScale Discovery).

If incorporation of DHA in plasma phospholipids is variable within the DHA treatment arm, possible factors that may influence incorporation (e.g. age of participants) will be explored between high and low incorporators.

Breast tissue from participants receiving DHA or placebo will be assessed for markers of apoptosis (e.g. caspase-3) by immunohistochemistry and calculated by image analysis.

Pathological complete response in resected breast tissue and all sampled axillary nodes will be assessed as absence of invasive cancer on haematoxylin and eosin evaluation as per standard of care.

Rate of chemotherapy associated grade 3 and 4 toxicities, and chemotherapy- associated hospitalizations will be compared between DHA and placebo arms.

The Cross Cancer Institute and the University of Alberta encourages and supports the responsible and ethical sharing of data from clinical trials. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov.

AHS Cancer Control Alberta

Canadian Institutes of Health Research (CIHR)

University of Alberta

Dietary supplementation with "OnLife" to improve signs and symptoms of CIPN in adult colon cancer patients who experienced a CIPN after adjuvant oxaliplatin-containing chemotherapy.

Dietary supplementation with "OnLife" to improve signs and symptoms of CIPN in adult breast cancer patients who experienced a CIPN after adjuvant paclitaxel regimen.

CIPN in Adjuvant Colon Cancer Patients

CIPN in Adjuvant Breast Cancer Patients

Daily dosing of dietary supplement OnLife

OnLife

Praxis für interdisziplinäre Onkologie & Hämatologie

Observational STudy to Evaluate the EFfectiveness of OnLife® in Improving CIPN in Patients With Colon or Breast Cancer After End of Adj. Therapy

An Observational STudy to Evaluate the EFfectiveness of OnLife® in Improving Chemotherapy-induced peripherAl NeurOpathy in Patients With Colon or Breast Cancer After End of Adjuvant Therapy

Incidence of grade 0/1/2/3/4 peripheral sensory and/ or motor neuropathy according to CTCAE v4.03 after end of adjuvant oxaliplatin-containing regimen (colon cancer) or adjuvant paclitaxel regimen (breast cancer)

Questionnaire EORTC QLQ-C30 is used to determine patients' health-related quality of life.

Questionnaire EORTC QLQ-CIPN20 is used to elicit patients' experience of symptoms and functional limitations related to CIPN.

Drug treatment of neuropathic pain is observed over the time of the OnLife® application and the month after the end of OnLife® application

linolenic acid/rinnavähk

Docosahexaenoic Acid (DHA) for Women With Breast Cancer in the Neoadjuvant Setting

Observational STudy to Evaluate the EFfectiveness of OnLife® in Improving CIPN in Patients With Colon or Breast Cancer After End of Adj. Therapy

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