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 Applicable
- Conditions
- Health Condition 1: C50- Malignant neoplasm of breast
- Registration Number
- CTRI/2020/03/023762
- Lead Sponsor
- Tata memorial hospita
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 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.
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.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 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. <br/ ><br>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. <br/ ><br>Timepoint: prevention of periphral neuropathy after 2nd cycle upto 12th cycle of weekly paclitaxel injection infusion