Abstract 188P
Background
The effects of saffron on mood disorders have already been established. More recently, its anti-neoplastic effects have provoked a great attention. This study aims to assess the effects of crocin administration during doxorubicin-based chemotherapy of breast cancer on anxiety, depression, and chemotherapy toxicity profile.
Methods
Seventy-two patients with non-metastatic Her2/neu positive or triple-negative breast cancer were enrolled and randomly assigned to receive either 30 mg/day of crocin or placebo during chemotherapy [2:2]. Beck's Depression and Anxiety Inventories were used at baseline and end of the trial. Also, the ECOG Common Toxicity Criteria were applied to assess chemotherapy side-effects.
Results
36 patients were enrolled in each group (Table). Table: 188P
Patients characteristics
| Variables | crocin (n=36) | Placebo (n=36) | p-Value |
| LVI + | 14 (38.9%) | 13 (36.1%) | 0.80∗ |
| HR + | 13 (36.1%) | 11 (30.6%) | 0.61∗ |
| Her2 + | 24 (66.7%) | 17 (44.4%) | 0.06∗ |
| Ki67 (<14%) | 3 (8.3%) | 7 (20%) | 0.18∗ |
| Molecular group Her2 + TNBC | 24 (66.7%) 12 (33.3%) | 17 (47.2%) 19 (52.8%) | 0.09∗ |
| Tumor grade (III) | 22 (61.1%) | 18 (50%) | 0.34∗ |
| Pathologic stage I II III | 2 (8.7%) 15 (65.2%) 6 (26.1%) | 7 (28%) 13 (52%) 5 (20%) | 0.23† |
| Clinical stage II III | 1 (7.7%) 12 (92.3%) | 1 (9.1%) 10 (90.9%) | 1∗ |
| Primary Surgery | 23 (63.9%) | 25 (69.4%) | 0.67∗ |
| Sx of node | |||
| ALND SLNB SLNB+ALND | 15 (57.7%) 2 (7.7%) 9 (34.6%) | 18 (64.3%) 5 (17.9%) 5 (17.9%) | 0.26∗ |
| CT regimen AC-T AC-TH TAC | 12 (34.3%) 22 (62.9%) 1 (2.9%) | 19 (52.7%) 16 (44.4%) 1 (2.9%) | 0.89∗ |
After the intervention, the degree of anxiety and depression decreased significantly in the crocin group (p=.001 for both) and increased significantly in the placebo-group (p=.006 and p=.036, respectively). There were significantly higher grade II-IV leukopenia (47.2% vs 19.4%, p=.012) in the crocin group, and grade II-IV hypersensitivity-reaction (30.6% vs. 5.6%, P=.006) in addition to neurological disorders (66.7% vs. 41.7%, p=.03) in the placebo-group. With a median follow-up of 16 months, tumor recurrences were reported in one patient (2.7 %) of crocin (bone metastasis) and six patients (16.6 %) of placebo group (local recurrence: 1 patient, brain metastasis: 3 patients, bone metastasis: 2 patients).
Conclusions
The results indicate that using crocin during chemotherapy in patients with breast cancer has ameliorated anxiety and depression. Moreover, leucopenia increased whereas hypersensitivity reaction and neurological disorders decreased in the crocin group. Also, a trend towards survival improvement was observed which is going to be investigated on longer follow up.
Clinical trial identification
IRCT20160706028815N4.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Mashhad University of Medical Sciences.
Disclosure
All authors have declared no conflicts of interest.