A study to compare efficacy of Abhyanga with Mahanarayana taila as an add on to the standard of care versus standard of care alone in chemotherapy induced peripheral neuropathy

Phase 3

Not yet recruiting

• Conditions: Drug-induced polyneuropathy. Ayurveda Condition: TVAK^-GATAVATAH,

• Registration Number: CTRI/2023/11/059688
• Lead Sponsor: Dr Namboodiri Aiswarya Raman

Brief Summary

This is a non randomized, clinical, control trial, comparing the efficacy of  Mahanarayana taila abhyanga ( on the affected parts- hands and/or feet) as and add on to the standard of care(60mg-1 tablet)( prescribed by the oncologist) compared to the administration of only the standard of care(60mg), daily, for 21 days, for chemotherapy induced peripheral neuropathy. The trial involves 30 participants suffering from chemotherapy induced peripheral neuropathy with 15 participants in each intervention and comparator group. The study will be conducted for 21 days in the Department of Oncology and Department of Integrative medicine at Amrita Institute of Medical Sciences , Kochi, Kerala. Primary and secondary outcomes will be measured on 22nd day after treatment. Primary outcome measure is changes in the symptoms of chemotherapy induced peripheral neuropathy measured using psychometric evaluation of the functional assessment of Cancer therapy / Gynecologic Oncology group- Neurotoxicity (FACT/GOG-NTX) questionnaire , Pain quality assessment (P-QAS) questionnaire and European organization for research and treatment of cancer quality of life questionnaire (EORTC QLQ-CIPN20). Secondary outcome measure observes change in grade of peripheral neuropathy based on NCI-CTCAE ( National cancer institute- common terminology criteria for adverse events) criteria. The study hypothesis is whether Abhyanga with Mahanarayana taila as an add on to the standard of care is effective in reducing the FACT-GOG, NCI-CTCAEv5, P-QAS and QLQ-CIPN20 scores of chemotherapy induced peripheral neuropathy in cancer patients between 18 to 60 years of age.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-02-11
• Study Start: 2023-11-19

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 1)Neuropathy attributed to chemotherapeutic agents with no prior history of attributable cause for chemotherapy induced peripheral neuropathy.
• 2)Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 3.
• 3)Self-reported neuropathy score greater than or equal to 3 on 0-10 scale and/or grade 2 or 3 neuropathy according to NCI-CTCAEv5 criteria.
• 4)Life expectancy more than 3 months.

Exclusion Criteria

• 1)Peripheral neuropathy other than those induced by neurotoxic chemotherapeutic agents. 2)Abnormal cognition and speech.
• causing difficulty in comprehension, expression and signing informed consent 3)Age below 18 and above 60 years. 4)Pregnancy, lactating mothers.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2)EORTC QLQ-CIPN20- The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20-Item Scale	On 22nd day
3)P-QAS- Pain Quality Assessment Scale	On 22nd day
Changes in symptoms of chemotherapy induced peripheral neuropathy based on:	On 22nd day
1)FACT/GOG-NTX- Psychometric evaluation of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group – Neurotoxicity questionnaire	On 22nd day

Secondary Outcome Measures

Name	Time	Method
Change in grade of peripheral neuropathy based on NCI-CTCAEv5	On 22nd day

Trial Locations

Locations (1)

Amrita Institute of Medical Sciences; 🇮🇳 Ernakulam, KERALA, India

Amrita Institute of Medical Sciences

🇮🇳Ernakulam, KERALA, India

Dr Namboodiri Aiswarya Raman

Principal investigator

9789006880

namboodiri.aishwarya@gmail.com