Randomized Trial of Curcumin to Reduce Mucositis in Autologous Transplant Setting

NCT04896164 | Unknown Phase 3 DMC

• 2 other identifiers: 900503CTRI/2018/09/015846
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Mucositis (Ulcerative)

Keywords

Curcumin; Mucositis; Autologous stem cell transplant

Outcome Measures

Primary Outcomes (1)

• Incidence of grade 3 and 4 oral mucositis

  In both groups, patients will be evaluated clinically for oral mucositis. The incidence of grade III/IV oral mucositis will be recorded as per WHO grading criteria.

  Day+28

Secondary Outcomes (28)

• Incidence of any grade of oral mucositis.

  Day+28

• Duration of grade 3 and 4 oral mucositis in both groups

  Day+28

• Incidence of use of Total Parenteral Nutrition

  Day+28

• Duration of use of Total Parenteral Nutrition

  Day+28

• Serum TNF alpha AUC (0-14)

  Day+14

Study Arms (2)

Investigational arm

EXPERIMENTAL

Patients in the investigational arm will receive curcumin lozenges (4 gm BD containing 400 mg curcumin BD) as prophylaxis from two days prior to receiving high dose chemotherapy .

Drug: Curcumin Lozenges

Control arm

PLACEBO COMPARATOR

patients in the control arm will receive matching placebo lozenges from two days prior to receiving high dose chemotherapy

Other: Placebo Lozenges

Interventions

Curcumin Lozenges DRUG

Curcumin lozenges (each containing 100 mg of curcumin) will be given at a dose of 4 lozenges (total dose 400 mg curcumin) BD. Formulation is Solid Lipid Curcumin Particle (SLCP). Oral curcumin lozenges will be given from two days prior to receiving high dose chemotherapy till day+28 of transplant.

Also known as: Longvida (Pharmanza Herbal Pvt Ltd.)

Investigational arm

Placebo Lozenges OTHER

Placebo lozenges will be given from two days prior to receiving high dose chemotherapy till day+28 of transplant.

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients 18 years and above.
• Patients who give written informed consent
• Patients with performance status - 0,1 or 2 (ECOG scale)
• Patients receiving any of the following high dose chemotherapy regimens for autologous transplant in any indicated malignant disease.
• Melphalan- 200 mg/m2 or more (MEL-200 mg/m2)
• Busulfan and Melphalan (BuMEL)
• Carmustine (BCNU), Etoposide, Cytosine Arabinoside and Melphalan ( BEAM)
• Patients who have creatinine clearance \> 50 ml/min
• Patients with serum bilirubin levels \< 2mg/dl. and serum liver enzymes (ALT or AST or both) lesser than 5 times the upper limit of normal value.

You may not qualify if:

• Patients who are on NSAIDs, aspirin, antioxidants or systemic steroids for more than 3 months and the last dose taken within the last one week.
• Patients being treated for active infection at the time of starting high dose chemotherapy.

Sponsors & Collaborators

• Tata Memorial Centre: lead

Study Sites (1)

Tata Memorial Centre

Navi Mumbai, Maharashtra, 410210, India

RECRUITING

MeSH Terms

Conditions

Stomatitis; Ulcer; Mucositis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Navin Khattry, MD, DM

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Navin Khattry, MD, DM

CONTACT

022-27405000; nkhattry@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The test drug and the placebo are available in USP grade plastic bottles. The bottles are identical in all respect. Each bottle have a unique identifier number provided by the manufacturer. The transplant physician, patients and the blinded statistician will remain blinded to the treatment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and BMT convener

Model Details: Patients receiving high dose chemotherapy with any of the conditioning regimens specified in the inclusion criteria will be randomized in two arms. Central telephonic randomization will be carried out with the help of a computer generated random sequence using permuted blocks.

Study Record Dates

• First Submitted: May 15, 2021
• First Posted: May 21, 2021
• Study Start: December 16, 2018
• Primary Completion: May 16, 2025
• Study Completion: May 16, 2025
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)