Table 1.
DHA WIN assessment schedule based on SPIRIT
| Timepoint | Study period | |||||||||||||
| Chemotherapy | ||||||||||||||
| Enrolment | Cycle 1 | Cycle 2 | Cycle 3 | Cycle 4 | Cycle 5 | Cycle 6 | Surgery | |||||||
| −t1 | Day 1* | Day 20 | Day 1 | Day 20 | Day 1 | Day 20 | Day 1 | Day 20 | Day 1 | Day 20 | Day 1 | Day 20 | tx | |
| Enrolment | ||||||||||||||
| Eligibility screen | X | |||||||||||||
| Informed consent | X | |||||||||||||
| Randomisation | X | |||||||||||||
| Interventions† | ||||||||||||||
| DHA 4.4 g/day (11–1 g capsules) |
|
|||||||||||||
| Vegetable oil placebo (11–1 g capsules/day) |
|
|||||||||||||
| Medication diary |
|
|||||||||||||
| Assessment of compliance |
X | X | X | X | X | X | ||||||||
| Assessments | ||||||||||||||
| Baseline/Ongoing | ||||||||||||||
| Demographic data collection | X | |||||||||||||
| Tumour analysis for grade/ER/PR/HER2‡ | X | |||||||||||||
| Physical exam/anthropometric measurements | X | X | X | X | X | X | X | X | ||||||
| Relevant medical history/current medical conditions | X | X | X | X | X | X | X | X | ||||||
| ESAS questionnaire | X | X | X | X | X | X | X | X | X | |||||
| Blood chemistry | X | X§ | ||||||||||||
| CBC and differential | X | X | X§ | |||||||||||
| Adverse events | X | X | X | X | X | X | X | X | ||||||
| Assessment of relevant toxicities | X | X | X | X | X | X | X | |||||||
| Primary outcome | ||||||||||||||
| Tumour analysis of Ki67 | X | X | ||||||||||||
| Secondary outcome | ||||||||||||||
| Assessment of immune function | X | X | X§ | |||||||||||
| Assessment of DHA incorporation | X | X | X | X | X | X | X | |||||||
| Tumour analysis of apoptosis and TILs | X | X | ||||||||||||
| Exploratory outcomes | ||||||||||||||
| Grade 1, 2 neuropathy assessment | X | X | X | X | X | X | X | |||||||
| Pathological complete response | X | |||||||||||||
| Breast conservation | X | |||||||||||||
| Assessment of surgical blood loss | X | |||||||||||||
| Study-associated questionnaires | ||||||||||||||
| Food Frequency Questionnaire¶ | X | |||||||||||||
| Quality of life questionnaire | X | X | ||||||||||||
| Godin Leisure-Time Exercise Questionnaire | X | X | X | X | X | X | X | |||||||
*Day 1 is day 1 of chemotherapy cycle.
†If patients’ chemotherapy is delayed due to associated toxicities, they will be encouraged to continue taking the DHA/placebo capsules as tolerated.
‡From previously collected biopsy.
§Tests required at the end of the last round of chemotherapy (ie, end of cycle 4, 5 or 6 as per patients’ individual treatment plan).
¶Food Frequency Questionnaire can be completed anytime within the first cycle (21 days) of chemotherapy.
CBC, complete blood count; DHA, docosahexaenoic acid; ER, estrogen receptor; ESAS, Edmonton Symptom Assessment System; HER2, human epidermal growth factor receptor 2; PR, progesterone receptor; SPIRIT, Standard Protocol Items: Recommendations for Interventional Trials; TILs, tumour infiltrating lymphocytes.