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

A Phase 2 randomized study to assess the radioprotective effect of oral chlorophyllin in acute toxicity reduction for Head Neck cancer patients receiving radiation / chemoradiation. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/055047

Enrollment

220

Registered

2023-07-11

Start date

Unknown

Completion date

Unknown

Last updated

2023-07-25

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

Conditions

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

Interventions

Intervention1: sodium Copper Chlorophyllin: In the intervention arm, in addition to the routine standard of care patients will be started on CHL 750 mg OD (provided by IDRS lab, Bengaluru) 7 days prio

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

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

Measure

Time frame

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

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Countries

India

Contacts

Public ContactDr Shwetabh Sinha

Tata Memorial Hospital

shwetabhsinha23@gmail.com02224177000

Outcome results

None listed

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