Study of Chlorophllin for reducing chemotherapy and radiotherapy treatment side effects in head and neck cancers

Phase 2

Conditions: Health Condition 1: C139- Malignant neoplasm of hypopharynx,unspecifiedHealth Condition 2: C119- Malignant neoplasm of nasopharynx,unspecifiedHealth Condition 3: C109- Malignant neoplasm of oropharynx,unspecifiedHealth Condition 4: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx

Registration Number: CTRI/2023/07/055047

Lead Sponsor: Tata Memorial Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

A.Patients with histologically proven Squamous Cell Carcinoma of the Oropharynx, Nasopharynx, Oral Cavity, Larynx and Hypopharynx planned for curative intent RT (either definitive or post-op).

B. Patients who have not received any other cancer directed treatment in the past.

C. Patients willing to sign the informed consent form.

Exclusion Criteria

A. Patients who have received NACT before local therapy

B. Patients > 70 years of age

C. Patients with severe comorbidities ( > 2 ACE 27 score)

D. Patients with baseline feeding tube

E. Synchronous / Metachronous Primaries

F. Non-Squamous Histology

G. Patients receiving non-platinum concurrent chemotherapy

H. Treated with palliative intent

I. Not reliable for follow up

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patient with any incidence of grade 3 or higher toxicity in 4 domains: Dermatitis, Mucositis, Dysphagia, Xerostomia) by CTCAE v 5.0 assessed during the course of RT to after 3 months post Ral Acute toxicity burdenTimepoint: After 3 months of Radiation Therapy

Secondary Outcome Measures

Name	Time	Method
A. Acute grade 2 dermatitis, Acute grade 2 mucositis Acute grade 2 dysphagia <br/ ><br> Acute grade 2 <br/ ><br>xerostomia assessed by CTCAE version 5.0 scintigraphy. <br/ ><br>B. Acute grade 2 hematologic toxicities. <br/ ><br>C. Late grade 2 skin toxicity late grade 2 subcutaneous fibrosis Late grade 2 dysphagia, Late grade 2 <br/ ><br>xerostomia, Late Grade 2 Hypothyroidism. <br/ ><br>D. EORTC QLQC 30 & HN 43 questionnaire at baseline conclusion & at all follow ups. <br/ ><br>E. Local Control Locoregional Control, Disease free survival and Overall survival <br/ ><br>F. Compliance to treatment <br/ ><br>G. TAME score comparisonTimepoint: at any time during the course of RT to 3 months post completion of RT