A study to select better pain killers while taking Radiation therapy along with chemotherapy for treatment of head and neck cancer.

Pain during concurrent chemoradiation in head and neck cancers: A Randomised study to compare analgesic effect of Diclofenac vs Tramadol

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/09/007302

Enrollment

128

Registered

2016-09-23

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: null- Patients who are receiving chemoradiation in head and neck cancer

Interventions

Intervention1: Diclofenac: Diclofenac is a NSAIDs (non steroidal anti-inflammatory drug )use for pain control dose is 50 mg thrice daily .Total duration of therapy will be 7 weeks Control Intervention

Eligibility

Inclusion criteria

Inclusion criteria: 1.Histologically or cytologically confirmed head and neck cancers receiving CTRT 2.Presence of radiation induced mucositis grade 1 or above 3.Pain related to mucositis on Visual analogue scale of 1 or more 4.ECOG PS 0-2 5.Normal haematological parameters 6.Normal Liver functions

Exclusion criteria

Exclusion criteria: 1.Use of analgesic for more than 1 week 2.Deranged serum creatinine > 1.5ULN 3.Known allergy to NSAID or tramadol

Design outcomes

Primary

Measure	Time frame
Pain ScoreTimepoint: 5,15,30,60,120,240,300 and 360 minutes.	—

Secondary

Measure	Time frame
1.Change in requirement of analgesic 2. Weight Loss 3. Quality of Life 4.ToxicityTimepoint: 1.1 week for chenge in requirement of analgesic 2.7 weeks for weight loss 3.7 weeks for quality of life 4.7 weeks for toxicity assessment	—

Countries

India

Contacts

Public ContactKavita Prakash Nawale

Tata Memorial Hospital

dramitjoshi74@gmail.com9769331525

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 18, 2026