Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04896164
Status:
RECRUITING
Last Update Posted:
2023-11-24
First Post:
2021-05-15
Brief Title:
Randomized Trial of Curcumin to Reduce Mucositis in Autologous Transplant Setting
Sponsor:
Tata Memorial Centre
Organization:
Tata Memorial Centre
Study Overview
Official Title:
Phase III Randomized Double Blind Placebo Controlled Study of Curcumin to Reduce Mucositis in Autologous Transplant Setting
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Mucositis is a very common complication in bone marrow transplant setting It is a result of injury to the gut caused by high dose chemotherapy Currently there are no universal protocols that have been accepted as a standard to prevent and treat mucositis in the transplant setting Post transplant upto 80 of patients suffer from a severe mucositis Proinflammatory cytokines play a major role in the development of mucositis Interventions that decrease the levels of these cytokines may be beneficial in preventing mucositis This study is aimed at evaluating the role of curcumin in reducing cytokine levels and the incidence and duration of mucositis in patients undergoing autologous stem cell transplantation
Detailed Description:
Mucositis is an inevitable side-effect of intensive conditioning therapy used for hematopoietic stem cell transplantation and affects the quality of life of patients undergoing transplant The incidence of oral mucositis WHO grades 34 with certain myeloablative conditioning regimens has been reported in up to 90 with range of severe mucositis WHO grade 34 from 10 to 78 Pro-inflammatory cytokines such as IL-1 IL-6 IL-8 IL-17 TNF-α TGF-B IFN-γ and certain prostaglandins play a central role in its pathogenesis Transcription factors such as NF-kappa B modify the genetic expression of these cytokines and enzymes which are critical in producing tissue damage
A number of agents and methods have been investigated to prevent or reduce mucositis in transplant setting Some of them are amifostine caphasol palifermin cryotherapy chlorhexidine glutamine GM-CSF histamine misoprostol laser therapy and traumeel but only palifermin and cryotherapy have shown significant benefit
Curcumin polyphenol derivative with low toxicity profile is commonly used in India for its anti-inflammatory actions Curcumin inhibits various inflammatory cytokines through inhibition of Nuclear Factor Kappa- β It is derived from the plant Curcuma longa In vitro studies have shown potent anti-inflammatory activity at concentrations of 1 umolL
The investigators conducted the first study evaluating the role of curcumin on oral mucositis in transplant setting In this pilot study n40 patients who received curcumin lozenges n30 had decreased levels of salivary TGF-β IL-17 and serum PGE2 compared to patients who did not receive the curcumin lozenges n10 Patients who received the curcumin lozenges had higher levels of serum IL-8 which is a prohealing cytokine The incidence of grade 3 and 4 oral mucositis and diarrhea was less in those who received curcumin lozenges Curcumin lozenges were also well tolerated and none of the 30 patients who were administered curcumin developed any treatment related grade 34 toxicity This encouraging data is the basis of the current phase III randomized study comparing curcumin lozenges to placebo to assess the ability of curcumin to reduce the incidence and duration of oral mucositis in patients undergoing autologous bone marrow transplantation
The formulation being used is a Solip Lipid Curcumin microParticle SLCP The formulation is developed by Pharmanza Herbals Pvt Ltd Gujarat India Gota et al reported a phase I clinical trial of SLCP where upto 4 grams of the formulation containing 20-30 curcumin was evaluated for safety and pharmacokinetics in patients with high-risk osteosarcoma Ref The SLCP formulation showed oral bioavailability of curcumin with linear pharmacokinetics Average peak plasma concentration of 41 ngmL was observed at the highest dose level of 4g All doses were well tolerated and no adverse events were observed Based on these observations on safety and bioavailability and the reported anti-inflammatory properties of curcumin it was envisaged that it could be potentially useful for the prophylaxis and treatment of oral mucositis following high-dose chemotherapy
A number of agents and methods have been investigated to prevent or reduce mucositis in transplant setting Some of them are amifostine caphasol palifermin cryotherapy chlorhexidine glutamine GM-CSF histamine misoprostol laser therapy and traumeel but only palifermin and cryotherapy have shown significant benefit
Curcumin polyphenol derivative with low toxicity profile is commonly used in India for its anti-inflammatory actions Curcumin inhibits various inflammatory cytokines through inhibition of Nuclear Factor Kappa- β It is derived from the plant Curcuma longa In vitro studies have shown potent anti-inflammatory activity at concentrations of 1 umolL
The investigators conducted the first study evaluating the role of curcumin on oral mucositis in transplant setting In this pilot study n40 patients who received curcumin lozenges n30 had decreased levels of salivary TGF-β IL-17 and serum PGE2 compared to patients who did not receive the curcumin lozenges n10 Patients who received the curcumin lozenges had higher levels of serum IL-8 which is a prohealing cytokine The incidence of grade 3 and 4 oral mucositis and diarrhea was less in those who received curcumin lozenges Curcumin lozenges were also well tolerated and none of the 30 patients who were administered curcumin developed any treatment related grade 34 toxicity This encouraging data is the basis of the current phase III randomized study comparing curcumin lozenges to placebo to assess the ability of curcumin to reduce the incidence and duration of oral mucositis in patients undergoing autologous bone marrow transplantation
The formulation being used is a Solip Lipid Curcumin microParticle SLCP The formulation is developed by Pharmanza Herbals Pvt Ltd Gujarat India Gota et al reported a phase I clinical trial of SLCP where upto 4 grams of the formulation containing 20-30 curcumin was evaluated for safety and pharmacokinetics in patients with high-risk osteosarcoma Ref The SLCP formulation showed oral bioavailability of curcumin with linear pharmacokinetics Average peak plasma concentration of 41 ngmL was observed at the highest dose level of 4g All doses were well tolerated and no adverse events were observed Based on these observations on safety and bioavailability and the reported anti-inflammatory properties of curcumin it was envisaged that it could be potentially useful for the prophylaxis and treatment of oral mucositis following high-dose chemotherapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CTRI201809015846 | REGISTRY | Clinical Trials Registry - India CTRI | None |