MedPath

A study to assess the effect of 3-month therapy of Ubidecarenone in treating cancer drug induced muscle wasting.

Phase 4
Conditions
Health Condition 1: R64- Cachexia
Registration Number
CTRI/2022/11/047338
Lead Sponsor
ADITYA VIKRAM SINGH
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. Patients of either gender with age equal to or more than 18 years 2. Patients with diagnosis of any stage of cancer and receiving cisplatin based regimen 3. Patients having the ability to understand and sign a written informed consent document

Exclusion Criteria

1. Patient receiving concomitant medication(s) known to cause or aggravate cancer

chemotherapy induced cachexia

2. Patient receiving any other investigational agent

3. Psychological or sociological conditions, addictive disorders, or family problems that would

preclude adherence with study drug or compliance with the protocol

4. Difficulty while swallowing oral medications due to prolonged emesis, mucositis, esophageal

dysfunction, etc

5. History of allergy to Ubidecarenone

6. Patient with any infectious disease like TB, HIV-AIDS requiring pharmacotherapy

7. Patient with history of uncontrolled co-morbid conditions like diabetes mellitus,

hypertension, chronic kidney disease, autoimmune diseases like amyloidosis

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Difference in CASCO scale (Cachexia Score) rating and Body composition analysis of cancer chemotherapy induced cachexia patients after 3 months of interventionTimepoint: 3 months
Secondary Outcome Measures
NameTimeMethod
Correlation of physical and biochemical parameters with severity of cancer chemotherapy induced cachexiaTimepoint: 3 months;Difference in Body Composition Analysis (BCA) of cancer chemotherapy induced cachexia patientsTimepoint: 3 months;Difference in Quality of Life score (QoL) of cancer chemotherapy induced cachexia patients using CASCO questionnaire (Cachexia Score questionnaire)Timepoint: 3 months;Levels of leptin in cancer chemotherapy induced cachexia patientsTimepoint: 3 months
© Copyright 2025. All Rights Reserved by MedPath