None listed
Conditions
Brief summary
The aim of this study is to evaluate whether Chinese herbal topical wash (Huo Xue Tong Luo Decoction) can relieve and/or prevent Oxaliplatin-induced peripheral neuropathy in gastrointestinal cancer patients. Who is it for? You may be eligible to join this study if you aged 18 years or above and are going to receive XELOX chemotherapy for gastrointestinal cancer. Study details Study participants will be allocated by chance (allocation ratio of 2:1) to one of the two intervention groups. One group will receive Huo Xue Tong Luo Decoction solution while the second group receives a placebo solution. Participants will use provided solutions to separately soak hands and feet for 20 minutes once a day for five consecutive days during each chemotherapy cycle (8 cycles). Participants will be required to complete a quantitative thermal testing from baseline, midway through each chemotherapy cycle and at the end of 3 months follow-up along with pain and QoL questionnaires in order for researchers to monitor whether the intervention is safe and whether it is effectively treating Oxaliplatin-induced peripheral neuropathy. It is hoped that the findings of this trial will establish the benefits of Huo Xue Tong Luo Decoction as topical wash for the prevention and treatment of Oxaliplatin-induced peripheral neuropathy in gastrointestinal cancer patients.
Interventions
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 s
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.
Sponsors
Western Sydney University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Exclusion criteria
1. Previous receipt of other neurotoxic chemotherapy (e.g. taxanes, platinum salts or vinca alkaloids) or pre-existing peripheral neuropathy (grade 1 or higher) caused by other chemotherapy 2. Pre-existing peripheral neuropathy or a history of peripheral neuropathy greater than grade 1 (National Cancer Institute Common Terminology Criteria for Adverse Events) due to any cause other than chemotherapy or participants with any co-existing condition that may impair peripheral nerve function (e.g. diabetes, peripheral vascular disease, HIV, alcohol, toxins, hereditary factors and nerve compression injuries) 3. Concurrent receipt of any agents preventing or treating neuropathy (e.g. glutamine, valproic acid, gabapentin, lamotrigine, topical lidocaine patch or gel, capsaicin cream, amifostine) 4. Pregnancy or potential to fall pregnancy 5. Having other complementary medicine treatments (e.g. acupuncture, moxibustion, cupping, internally used herbal formula, externally used herbal formula) for any other current conditions 6. Lifetime or current severe mental illness 7. Other medical conditions which would preclude study intervention or make study participation unsafe such as inflammatory skin disease, ongoing infection, and moderate and severe chronic heart failure
Outcome results
None listed