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

A randomized placebo controlled pilot study to evaluate the efficacy of three month therapy of ubidecarenone in patients with cisplatin based regimen induced cachexia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/11/047338
Enrollment
60
Registered
2022-11-15
Start date
Unknown
Completion date
Unknown
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: R64- Cachexia

Interventions

Intervention1: Ubidecarenone (Coenzyme Q): Dose: 100 mg Frequency: Once a day Route of administration: Oral Duration of Intervention: 3 months Control Intervention1: PLACEBO: Dose: 100 mg Frequency:

Sponsors

ADITYA VIKRAM SINGH
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

India

Contacts

Public ContactADITYA VIKRAM SINGH

JAWAHARLAL NEHRU MEDICAL COLLEGE AND HOSPITAL ALIGARH MUSLIM UNIVERSITY

fahmad32@yahoo.com7417735300

Outcome results

None listed

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