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

Not yet recruiting

• Conditions: Malignant neoplasm of breast,

• Registration Number: CTRI/2020/03/023762
• Lead Sponsor: Tata memorial hospita

Brief Summary

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As it helps in the prevention of the paclitaxel induced peripheral neuropathy the frozen gloves and socks can be used for the patient in future for treatment

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-03-03
• Study Start: 2020-09-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 20

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

• 1.Previous treatment with taxane chemotherapy 2.Medical history of Reynaud’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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Tata memorial hospital, Parel; 🇮🇳 Mumbai, MAHARASHTRA, India

Tata memorial hospital, Parel

🇮🇳Mumbai, MAHARASHTRA, India

MEERA SHARAD ACHAREKAR

Principal investigator

9769993848

machrekar@actrec.gov.in