A Study to Assess the Anti-Emetic Efficacy of Ginger in Children and Adolescents Receiving Chemotherapy

NCT00940368 | Unknown Phase 3 DMC

• 1 other identifier: T-10/27.02.2009
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Ginger root powder is found to be significantly effective,when given as an add-on therapy in reducing chemotherapy induced nausea and vomiting in children and adolescents receiving chemotherapy. It is very cost effective and as compared to the other add-on therapy drug like aprepitant.

Conditions

Nausea; Vomiting

Keywords

Nausea; Vomiting; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Reduction in the Incidence and Severity of Chemotherapy Induced Nausea and Vomiting

  6 months

Study Arms (2)

Ginger arm

EXPERIMENTAL

The patients in this arm will be randomly selected in each cycle of chemotherapy. The unit of randomization is the cycle of chemotherapy. In each cycle of chemotherapy of all patients recruited in the study will be categorized using the computer generated random numbers. The patients in the ginger arm; Group A will be getting ginger powder capsules according to their body weight;ie;there are two weight categories within Group A: Category 1- 20kg-40kg Category 2- 40kg-60kg Category 1 will receive 2 capsules 3 times a day,ie; 1gram ginger powder per day Category 2 will receive 5 capsule divided in 3 doses per day,ie; 2gram ginger powder per day

Dietary Supplement: Provision of capsules containing ginger powder or placebo

Placebo arm

PLACEBO COMPARATOR

Patients (children and adolescents) will be included in this arm after randomization of the cycle of chemotherapy of the patient. Starch powder/Glucose powder is used as placebo.The patients in the placebo arm; Group B will be getting ginger powder capsules according to their body weight;ie;there are two weight categories within Group B: Category 1- 20kg-40kg Category 2- 40kg-60kg Category 1 will receive 2 capsules 3 times a day,ie; 1gram placebo powder per day Category 2 will receive 5 capsule divided in 3 doses per day,ie; 2gram placebo powder per day

Dietary Supplement: Provision of capsules containing ginger powder or placebo

Interventions

Provision of capsules containing ginger powder or placebo DIETARY_SUPPLEMENT

The patients(children and adolescents) will be provided with Capsules containing either ginger powder or placebo on the three days when they receive chemotherapy. For weight category 1(20-40kg),6 capsules are given in three divided doses and the amount of ginger powder administered per day is 1 gram. For weight category 2(40-60kg), 5 capsules are given in three divided doses and the amount of ginger powder administered per day is 2 gram.

Also known as: Tulsi Ayurvedic Products & Research(P)LTd,U.P.,India

Ginger arm; Placebo arm

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All patients must have a histologically confirmed diagnosis of Osteosarcoma/ Malignant Fibrohistiocytoma of bone that is currently being treated with chemotherapy with high emetogenic potential chemotherapeutic agent(Cisplatin at a dose 120mg/m2 ; Adriamycin 75 mg/m2)
• Age group : 8-21 yrs.
• Weight : greater than or equal to 20 kg and less than 40 kg in Category 1
• Weight : greater than or equal to 40 kg and less than 60 kg in Category 2
• Patients who are willing to participate in study.
• Patients or their parents who can understand Hindi or English.

You may not qualify if:

• Patients of age \<8 yrs or age \>21 yrs.
• Weight \< 20 kg and greater than or equal to 40 kg in Category 1
• Weight \< 40 kg and greater than or equal to 60 kg in Category 2
• Patients receiving chemotherapy with drugs other than Cisplatin.
• Patients receiving a dosage of chemotherapy with Cisplatin\<120 mg/m2.

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

Dr. B.R. Ambedkar Institute Rotary Cancer Hospital

New Delhi, National Capital Territory of Delhi, 110049, India

RECRUITING

Related Publications (1)

• Pillai AK, Sharma KK, Gupta YK, Bakhshi S. Anti-emetic effect of ginger powder versus placebo as an add-on therapy in children and young adults receiving high emetogenic chemotherapy. Pediatr Blood Cancer. 2011 Feb;56(2):234-8. doi: 10.1002/pbc.22778. Epub 2010 Sep 14.

  PMID: 20842754 DERIVED

MeSH Terms

Conditions

Nausea; Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anu K, BSc.Nursing

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Kamlesh K Sharma, MSc.Nursing

  All India Institute of Medical Sciences

  STUDY DIRECTOR

• Sameer Bakhshi, MD

  All India Institute of Medical Sciences

  STUDY CHAIR

• Y K Gupta, MD,FAMS,FIPS

  All India Institute of Medical Sciences

  STUDY CHAIR

Central Study Contacts

Anu K, BScNursing

CONTACT

9109891661848; anukaiims@gmail.com

Kamlesh K Sharma, MScNursing

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 15, 2009
• First Posted: July 16, 2009
• Study Start: June 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: January 1, 2010
• Last Updated: July 28, 2009

Record last verified: 2009-07

Locations

IN (1)