Can Chinese herbal topical wash relieve and/or prevent Oxaliplatin-induced peripheral neuropathy?

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2017
INTERVENTION: Huo Xue Tong Luo Decoction will be provided as a whole concentrated granulated extract (45 g) (Salvia miltiorrhiza; Carthamus tinctorius L.;Paeonia veitchii; Ligusticum Siense; Angelica sinensis; Prunus persica; Rehmannia glutinosa; Polygonum bistort; Ginger) for topical use. Participants will dissolve daily sachets in a basin with 3 litres of warm water (approximately 37‐ 40 degrees) at home. Once the sachet is dissolved, participants will soak both hands in the basin for 20 minutes, and then soak both feet for 20 minutes once per day. Discard the solution when finished. Participants will have a total of 40 days using HXTLD treatments (5 days/per cycle x 8 cycles) over the six months of chemotherapy treatment. To ensure compliance, the participants have to return each cycle’s home diary and the empty sachets at each next visit. Participants will complete eight cycles’ home intervention records with one follow up home intervention record. CONDITION: chemotherapy‐induced peripheral neuropathy colorectal cancer gastric cancer gastrointestinal cancer oesophageal cancer PRIMARY OUTCOME: Change in the reduction of severity and/or delay onset of peripheral neuropathy by cold‐evoked pain threshold measured by thermal quantitative sensory testing (QST) SECONDARY OUTCOME: A composite secondary outcome: Change in dose administered, dose reductions or delays caused by OXL PN by review medical records. Acute pain symptom/cumulative sensory peripheral neurptoxicity/total motor/autonomic scores measured by the European Organization for Research and Treatment of Cancer quality of life questionnaire to assess CIPN (EORTC QLQ‐ CIPN20) Assess the incidence and severity of acute neurotoxic symptoms measured by Oxaliplatin Acute Symptom Questionnaire Change in cumulative sensory peripheral neurotoxicity/total motor/autonomic scores measured by the European Organization for Research and Treatment of Cancer quality of life questionnaire to assess CIPN (EORTC QLQ‐ CIPN20) Change in overall neuropathic pain measured by numerical rating scale (NRS) Change in quality of life measured by QLQ‐C30 questionnaire—Quality of life questionnaire‐core 30, European Organisation for Research and Treatment of Cancer (HRQOL QLQ‐C30) Drop‐out rate caused by discontinuation of oxaliplatin by review medical records. Muscle tenderness as measured by Pressure Pain threshold (PPT) To assess any side‐effects of Chinese herbal medicine in patients measured by safety assessments using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI‐CTCAE4.0) INCLUSION CRITERIA: 1. Gastrointestinal cancer patients (age greater than 18) receiving XELOX chemotherapy (oral capecitabine and Oxaliplatin chemotherapy combination) 2. Expected life expectancy greater than 9 months 3. Australia‐modified Karnofsky Performance Status (AKPS) Score > 70 4. White blood cell count [WBC] greater than 3.4 ×109/L 5. Absolute neutrophil count [ANC] greater than 1500/µL 6. Platelets greater than 100 ×109/L 7. Haemoglobin greater than 10.0 g/Dl 8. Creatinine greater than 1.5 times the upper normal limit 9. Full understanding of the study information provided by the investigator 10. Willing to comply with study treatment and data collection requirements
Epistemonikos ID: 1b32ac0fd1ab515932c33c38f9cbf4ae1895880f
First added on: Aug 25, 2024