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.

â??Evaluation of the effect of foot bathing on peripheral neuropathy in patients receiving oxaliplatin containing chemotherapy for colorectal cancer at Tata Memorial Hospital.â??

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/04/032906

Enrollment

516

Registered

2021-04-19

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C189- Malignant neoplasm of colon, unspecified

Interventions

Intervention1: Warm foot bath therapy: In experimental arm, Warm foot bath therapy Each session-15min. Participants will receive warm foot bath therapy prior oxaliplatin for 15min.and post oxaliplatin

but only receive routine treatment. Control Intervention1: standard routine treatment No interventions: In experimental arm, Warm foot bath therapy Each session-15min. Participants will receive warm f

but only receive standard routine treatment.

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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 -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.	—

Measure

Time frame

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 -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

Measure	Time frame
1.To evaluate the safety and feasibility of the study. 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. Timepoint: Baseline assessment- 1st day of first CT cycle using FACT-GOG NTX tool -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.	—

Measure

Time frame

1.To evaluate the safety and feasibility of the study. 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. Timepoint: Baseline assessment- 1st day of first CT cycle using FACT-GOG NTX tool -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.

—

Countries

India

Contacts

Public ContactChaitali Laxman Gavandalkar

College of Nursing,Tata Memorial Hospital

dsouza.angaikwad@gmail.com9833784429

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026