Impact of the preoperative use of synbiotics in colorectal cancer patients: A prospective, randomized, double-blind, placebo-controlled study

Nutrition ◽  
2019 ◽  
Vol 58 ◽  
pp. 40-46 ◽  
Author(s):  
Camila Brandão Polakowski ◽  
Massakazu Kato ◽  
Vinicius Basso Preti ◽  
Maria Eliana Madalozzo Schieferdecker ◽  
Antonio Carlos Ligocki Campos
Keyword(s):  
Colorectal Cancer ◽  
Cancer Patients ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Colorectal Cancer Patients

The role of reduced glutathione on oxaliplatin-induced neuropathy in colorectal cancer patients

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 19539-19539
Author(s):  
G. Lelli ◽  
G. Romano ◽  
R. Ardito ◽  
A. Bochicchio ◽  
A. Capobianco ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Cancer Patients ◽  
Sensory Neuropathy ◽  
Treatment Interruption ◽  
Sensory Loss ◽  
Controlled Study ◽  
Common Side Effect ◽  
Oxaliplatin Treatment ◽  
Randomised Controlled ◽  
Colorectal Cancer Patients

19539 Background: Peripheral sensory neuropathy is a common side-effect of oxaliplatin based chemotherapy. The neuropathy is cumulative and dose-related. Symptoms include sensory ataxia and dysesthesia of the limbs, mouth, throat and larynx, and may be exacerbated by exposure to cold. Studies suggest that Glutathione (GSH) is neuroprotective against oxaliplatin-induced neuropathy. Methods: From Jan. 2004, 83 consecutive colorectal cancer patients (pts) elegibile to oxaliplatin-based regimen were treated with GSH 1500 mg/mq over a 15-minute infusion period before oxaliplatin. Treatment-related toxicity was evaluated based on National Cancer Institute (NCI) Criteria. Results: After four cycles of chemotherapy, 5 pts (6%) experienced G1 neurotoxicity. After eight cycles, 2 pts (2.4%) experienced G2 sensory neuropathy (duration < 7 days) and 8 (9.6%) pts G1. After 12 cycles, G3 sensory neuropathy was observed in 2 pts (2.4%), G2 in 8 (9.6%) and G1 in 11 pts (13%). Neither G4 sensory neuropathy was registered nor treatment interruption was required. Conclusions: These findings suggest that use of GSH may protect from oxaliplatin-induced neuropathy. In fact, in our series, only 2 (2.4%) pts experienced severe paresthesia interfering with daily activities and none hade permanent sensory loss. However, only a well designed randomised controlled study will definitely prove the protective effect of GSH on oxaliplatin induced neurotoxicity. No significant financial relationships to disclose.

Results of the X-PECT study: A phase III randomized double-blind, placebo-controlled study of perifosine plus capecitabine (P-CAP) versus placebo plus capecitabine (CAP) in patients (pts) with refractory metastatic colorectal cancer (mCRC).

2012 ◽  
Vol 30 (18_suppl) ◽  
pp. LBA3501-LBA3501 ◽  
Author(s):  
Johanna C. Bendell ◽  
Thomas J. Ervin ◽  
Neil N. Senzer ◽  
Donald A. Richards ◽  
Irfan Firdaus ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Phase Ii ◽  
Median Overall Survival ◽  
Phase Iii ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Randomized Phase Ii ◽  
Phase Iii Study

LBA3501 Background: Perifosine (P) is an oral, synthetic alkylphospholipid that inhibits or modifies signal transduction pathways including AKT, NFkB and JNK. A randomized phase II study examined P-CAP vs. CAP in pts with 2nd or 3rd line mCRC. This study showed improvement in mTTP (HR 0.254 [0.117, 0.555]) and mOS (HR 0.370 [0.180,0.763]). Based on these results, a randomized phase III study of P-CAP vs. CAP with a primary endpoint of overall survival (OS) in pts with refractory mCRC was initiated. Methods: The study was a prospective, randomized, double-blind, placebo-controlled randomized phase III trial. Eligible pts had mCRC which was refractory to all standard therapies. Pts randomized 1:1 to Arm A = P-CAP (P 50 mg PO QD + CAP 1000 mg/m2PO BID d1-14) or Arm B = CAP (placebo + CAP 1000 mg/m2 PO BID d 1-14). Cycles were 21 days. Baseline tumor block collection and a biomarker cohort of pts with pre- and on-treatment tumor and blood samples were performed. Results: Between 3/31/10 and 8/12/11, 468 pts were randomized, 234 pts were in each arm. Baseline demographics were balanced between the arms: age < 65y (A: 65%, B: 58.5%), male (A: 57.7%, B: 53.0%), ECOG PS 0 (A: 39.7%, B: 39.7%), K-ras mutant (A: 50.4%, B: 51.3%), and median number of prior therapies (A: 4, B: 4). As of 3/19/12, median follow up was 6.6 months. Median overall survival: Arm A = 6.4 mo, Arm B = 6.8 mo, HR 1.111 [0.905,1.365], p = 0.315. Median overall survival for K-ras WT pts: Arm A = 6.6 mo, Arm B = 6.8 mo, HR 1.020 [0.763,1.365], p = 0.894; K-ras mutant pts: Arm A = 5.4 mo, Arm B = 6.9 mo HR 1.192 [0.890,1.596], p = 0.238. Conclusions: Despite promising randomized phase II data, this phase III study shows no benefit in overall survival adding perifosine to capecitabine in the refractory colorectal cancer setting. Response rate, progression free survival, and safety data will be presented. Biomarker analysis is pending to see if subgroups of patients may have potential benefit.

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