A clinical trial to study the effects of foot bathing in patients receiving oxaliplatin containing chemotherapy in patients with colorectal cancer at Tata Memorial Hospital.
- Conditions
- Health Condition 1: C189- Malignant neoplasm of colon, unspecified
- Registration Number
- CTRI/2021/04/032906
- Lead Sponsor
- Tata Memorial Centre Dr E Borges roadParelMumbai
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Age 18-65years and who volunteer for this study with written informed consent.
2.Stage II, III, IV CRC (Colorectal cancer) patients
3.Planned for receiving oxaliplatin based chemotherapy
1.The patients with history of pre-existing peripheral neuropathy at baseline screening
2.Patients who have received previous neurotoxic cytotoxic chemotherapy (taxanes, platinum salts or vinca alkaloids)
3.Patients with known diabetes mellitus, hypertension, alcohol abuse and neurological disorders, nutritional issues, renal disorders, peripheral vascular disease.
4.The patients with lupus, lyme disease, rheumatoid arthritis, Guillain-Barre Syndrome
5.Having any previous history of psychotic disorders or are on antipsychotic drugs.
6.Patients with painful lesions, allergic reactions, infections on lower extremities.
7.Patients with thrombocytopenia, dyselectrolytemia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the effects of foot bathing on peripheral neuropathy in patients receiving oxaliplatin containing chemotherapy for colorectal cancer.Timepoint: Baseline assessment- 1st day of first CT cycle using FACT-GOG NTX tool <br/ ><br>-Assessment of CIPN on 1st day of 2nd,3rd,4th,5th,6th chemotherapy cycle and assessment of CIPN and associated QOL using FACT-GOG NTX tool on 1st day of 2nd and 6th chemotherapy cycle and three months after completion of 6th cycle and six months after completion of 6th cycle.
- Secondary Outcome Measures
Name Time Method 1.To evaluate the safety and feasibility of the study. <br/ ><br>2.To compare the rate of grade 2 or worse cumulative neurotoxicity, between participants in control and experimental arm measured by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 till the end of 6months of therapy. <br/ ><br>Timepoint: Baseline assessment- 1st day of first CT cycle using FACT-GOG NTX tool <br/ ><br>-Assessment of CIPN on 1st day of 2nd,3rd,4th,5th,6th chemotherapy cycle and assessment of CIPN and associated QOL using FACT-GOG NTX tool on 1st day of 2nd and 6th chemotherapy cycle and three months after completion of 6th cycle and six months after completion of 6th cycle. <br/ ><br>