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

NCT ID: NCT00940368

Last Updated: 2009-07-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2010-01-31

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.

Detailed Description

Cisplatin is a chemotherapeutic agent with high emetogenic potential. High doses of Cisplatin (120 mg/m2) induces nausea and vomiting in 90 % of patients. More than 60% of patients experience nausea and vomiting even if they are getting the conventional anti emetic medications.

Children and adolescents with cancer are using complementary and alternative medicine (CAM) to relieve symptoms, reduce side effects of treatment, and cope with the emotional aspects of having a life-threatening illness. Parental decisions about using CAM should be based on studies of efficacy and safety .

Ginger is already used in traditional folk medicine to treat nausea and vomiting.Additionally, ginger's ability to block 5-HT3 receptors and its free-radical scavenging action in the gut suggests that it may be beneficial for reducing both the prevalence and severity of chemotherapy induced nausea and vomiting.

Ginger is an easily available and cost effective substance in Indian scenario; (1gm costs less than one rupees). A dose of 1-2 gm of ginger is found to have favourable effects in reducing the incidence of nausea and vomiting. There are not much side-effects of ginger have been established so far, except mild stomach upset, increased burping and nausea seen in very few patients after the ingestion of ginger. Ginger is a widely available,affordable and acceptable natural substance which is to be included as an additional treatment option for chemotherapy induced nausea and vomiting which will significantly improve the health, compliance with treatment and quality of life of patients receiving chemotherapy.

Conditions

Nausea; Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Ginger arm

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

Group Type: EXPERIMENTAL

Provision of capsules containing ginger powder or placebo

Intervention Type: 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.

Placebo arm

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

Group Type: PLACEBO_COMPARATOR

Provision of capsules containing ginger powder or placebo

Intervention Type: 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.

Interventions

Provision of capsules containing ginger powder or placebo

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Tulsi Ayurvedic Products & Research(P)LTd,U.P.,India

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

All India Institute of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

AIIMS

Principal Investigators

Anu K, BSc.Nursing

Role: PRINCIPAL_INVESTIGATOR

All India Institute of Medical Sciences

Kamlesh K Sharma, MSc.Nursing

Role: STUDY_DIRECTOR

All India Institute of Medical Sciences

Sameer Bakhshi, MD

Role: STUDY_CHAIR

All India Institute of Medical Sciences

Y K Gupta, MD,FAMS,FIPS

Role: STUDY_CHAIR

All India Institute of Medical Sciences

Locations

Dr. B.R. Ambedkar Institute Rotary Cancer Hospital

New Delhi, National Capital Territory of Delhi, India

Site Status: RECRUITING

Countries

India

Central Contacts

Anu K, BScNursing

Role: CONTACT

anukaiims@gmail.com

9109891661848

Kamlesh K Sharma, MScNursing

Role: CONTACT

Facility Contacts

Anu K, BSc. Nursing

Role: primary

anukaiims@gmail.com

9109891661848

Kamlesh K Sharma, MSc. Nursing

Role: backup

kamlesh_con@yahoo.co.in

91098911336985

References

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.

Reference Type: DERIVED

PMID: 20842754 (View on PubMed)

Other Identifiers

T-10/27.02.2009

Identifier Type: -

Identifier Source: org_study_id