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To check effectiveness of oral Ketamine as an analgesic adjuvant to oral Morphine, Amitriptyline and Pregabalin on cancer pain relief, opioid analgesic consumption and functional improvement in cancer patients

Effect of Oral Ketamine as Analgesic Adjuvant to Oral Morphine, Amitriptyline and Pregabalin on cancer pain relief, opioid analgesic consumption and functional improvement in patients with cancer: Prospective, Double Blind, Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/02/023296
Enrollment
44
Registered
2020-02-13
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: C50- Malignant neoplasm of breast Health Condition 2: C40-C41- Malignant neoplasms of bone and articular cartilage Health Condition 3: C15-C26- Malignant neoplasms of digestive organs Health Condition 4: C51-C58- Malignant neoplasms of female genital organs Health Condition 5: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx Health Condition 6: C60-C63- Malignant neoplasms of male genital organs Health Condition 7: C30-C39- Malignant neoplasms of respiratory and i

Interventions

Intervention1: Oral Ketamine: Ketamine 50 mg per milliliter Injection administered orally 0.5 mg/kg, three times a day Control Intervention1: Placebo [Oral Normal Saline]: Placebo solution, administer

Sponsors

HCG Cancer Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age 18 to 75 years Patients with malignant solid tumors Patients with cancer pain of Numerical Rating Scale greater than or equal to 4, not controlled by Oral Morphine 60 mg per day and, neuropathic pain medications Oral Amitriptyline 50 mg per day and Oral Pregabalin 150 mg per day

Exclusion criteria

Exclusion criteria: Patients who had received Ketamine for chronic pain within 6 months Comorbidities contraindicating the use of Ketamine(e.g. history of hypertension or on antihypertensive therapy, history of heart failure, history of angina & myocardial infarction in last 6 weeks, aneurysm, cerebral trauma) Patient with history of substance use disorder Patients not able to take oral drugs Patients with coexisting liver or renal disease Patients who received radiotherapy or surgical therapy within past 2 months Patients having pain as a side effect of chemotherapy Patients with brain metastases of cancer

Design outcomes

Primary

MeasureTime frame
Pain intensity (Numerical Rating Scale 0-10) Opioid analgesic consumption (Morphine equivalent)Timepoint: Before Enrollment Day 1, 2 and 3 End of week 1, 2, 3 and 4—

Secondary

MeasureTime frame
Functional improvement (Brief Pain Inventory - Short form Mean Interference Scale)Timepoint: Before Enrollment Day 1, 2 and 3 End of week 1, 2, 3 and 4—

Countries

India

Contacts

Public ContactDr Jay Panchal

Community Oncology Center

dr.geetajoshi@gmail.com9824075707

Outcome results

None listed

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