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a study to assess the effect of iced gloves and socks in prevention of tingling prickling numbness and muscle weakness in hand and foot of breast cancer patients caused by paclitaxel chemotherapy injection in tertiary care cancer hospital

a study to assess the feasibility safety and efficacy of frozen gloves & socks application on prevention of pacllitaxel induced peripheral neuropathy in breast cancer patient in tertiary carecancer hospital

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/03/023762
Enrollment
20
Registered
2020-03-04
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: C50- Malignant neoplasm of breast

Interventions

Intervention1: southwest technology elasto gel frozen gloves and socks: In dominating hand and foot we will apply frozen gloves & socks (elasto gel temp is -10 to -20 degrees Celsius). for prevention

Sponsors

Tata memorial hospita
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Adult >18yrs. 2.Prescribed Paclitaxel as a single or multimodal treatment for breast cancer diagnosis for 12 weeks. 3.No disorders of the nails or skin of the hand at the start of treatment 4.Able to provide informed consent in English/Hindi/Marathi/Bengali. 5.No baseline arteriovenous thrombosis/claudication or hypersensitivity disorder, allergy.

Exclusion criteria

Exclusion criteria: 1. Previous treatment with taxane chemotherapy 2. Medical history of Reynaudâ??s phenomenon, distal metastases,ungual pathology,arteriopathy, cold intolerance, peripheral neuropathy of any grade. 3. Not fit for participation in the opinion of the treating oncologist/physician.

Design outcomes

Primary

MeasureTime frame
This study will investigate the feasibility and safety of cryotherapy, in the form of frozen gel gloves & socks, with respect to the prevention of paclitaxel-induced peripheral neuropathy in cancer patients.Timepoint: to check if the frozen gloves(temp -10 deg to -20 deg) which is to be used in the study is safe and tolerable by the patient or not at the time of administration of paclitaxel injection infusion

Secondary

MeasureTime frame
1) To assess the efficacy of frozen gel gloves & socks, with respect to the prevention of paclitaxel-induced peripheral neuropathy in cancer patients. 2) To assess the incidence and severity of peripheral neuropathy in the ice treated limb as compared to nontreated side prevention of paclitaxel induced peripheral neuropathy. Timepoint: prevention of periphral neuropathy after 2nd cycle upto 12th cycle of weekly paclitaxel injection infusion

Countries

India

Contacts

Public Contactvaishali anandrao chalke

Tata Memorial Centre

machrekar@actrec.gov.in9769993848

Outcome results

None listed

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