Use of Chlorophyllin to reduce ulcers of the mouth after high doses of chemotherapy and radiation given before transplant

Chlorophyllin as an adjunct for Reducing Oral Mucositis in Myeloablative Total Body Irradiation

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/066144

Enrollment

Registered

2024-04-23

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

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

Conditions

Health Condition 1: C969- Malignant neoplasm of lymphoid, hematopoietic and related tissue, unspecified

Interventions

Intervention1: sodium copper chlorophyllin (CHL): oral sodium copper chlorophyllin (CHL) at a dose of 750mg once daily (OD) on empty stomach. CHL will be administered 48 hours prior to initiation of c

Eligibility

Inclusion criteria

Inclusion criteria: -First allogeneic stem cell transplant -Total body irradiation dose (fractionated) =8Gy

Exclusion criteria

Exclusion criteria: -Known hypersensitivity or contraindications against sodium chlorophyllin (CHL)

Design outcomes

Primary

Measure	Time frame
To evaluate incidence of grade III and IV Oral mucositis in patients receiving CHL with myeloablative total body irradiation (TBI) based regimens.Timepoint: day+28 post transplant	—

Secondary

Measure	Time frame
-To evaluate duration of grade 3-4 oral mucositis -To evaluate incidence and duration of total parenteral nutrition (TPN) -To evaluate incidence and duration of opioid analgesics -To evaluate other treatment related grade III and IV toxicities including nausea, vomiting, and diarrhoea -To evaluate time to engraftment -To estimate the cumulative incidence (CI) of acute GVHD at 100 days post allogeneic hematopoietic cell transplantation (allo-HCT). -Evaluate the Non-relapse mortality (NRM) Timepoint: 2 years	—

Measure

Time frame

-To evaluate duration of grade 3-4 oral mucositis -To evaluate incidence and duration of total parenteral nutrition (TPN) -To evaluate incidence and duration of opioid analgesics -To evaluate other treatment related grade III and IV toxicities including nausea, vomiting, and diarrhoea -To evaluate time to engraftment -To estimate the cumulative incidence (CI) of acute GVHD at 100 days post allogeneic hematopoietic cell transplantation (allo-HCT). -Evaluate the Non-relapse mortality (NRM) Timepoint: 2 years

—

Countries

India

Contacts

Public ContactDr Sumeet Mirgh

Advanced Centre for Treatment Research and Education in Cancer Tata Memorial Centre

drsumeetmirgh@gmail.com8130140245

Outcome results

None listed

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