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Effects of Curcumin along with Radiotherapy of Oral Cancer

Effect of Curcumin on Radiation induced Oral Mucositis: A randomised controlled trial - ROMAC TRIAL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/12/006413
Enrollment
60
Registered
2015-12-04
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- â?¢Post surgical resection cases of Carcinoma Buccal Mucosa, Gingiva/Alveolus, Retromandibular Trigone, Oral Tongue, Lips, Floor of Mouth, Hard Palate â?¢Histology proven Squamous cell carcinoma

Interventions

Intervention1: Curcumin BCM95 (1000mg/day): Capsules Curcumin BCM95 (1000mg/day) per Oral for 6 weeks with Radiotherapy Intervention2: Placebo: Capsules Placebo daily for 6 weeks Intervention3: Curcum

Sponsors

Dr Tej Prakash Soni
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Post surgical resection cases of Carcinoma Buccal Mucosa, Gingiva/Alveolus, Retromandibular Trigone, Oral Tongue, Lips, Floor of Mouth, Hard Palate • Histology proven Squamous cell carcinoma • Age >18 years to • WHO Performance Status 0-1 • No prior history of Radiotherapy to head neck region

Exclusion criteria

Exclusion criteria: • Primary Site of Oropharynx, Nasopharynx, Larynx • History of previous Radiotherapy to head neck region • Histopathology other than squamous cell carcinoma

Design outcomes

Primary

MeasureTime frame
To determine whether supplementation of curcumin reduces the severity of Oral Mucositis in patients receiving radiotherapy for Oral CancersTimepoint: One year from enrollment of the first patient

Secondary

MeasureTime frame
TO DETERMINE THE QUALITY OF LIFETimepoint: 6 WEEKS PER PATIENT

Countries

India

Contacts

Public ContactDr Tej Prakash Soni

Bhagwan Mahaveer Cancer Hospital and Research Centre, Jaipur

drtejprakashsoni@yahoo.co.in9602240611

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 15, 2026