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

Nausea Clinical Trial

Official title:

A Study to Evaluate the Anti-Emetic Effect of Ginger Powder Vs Placebo as an Add-on Therapy in Children and Adolescents Receiving Chemotherapy : A Randomized Controlled Trial

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00940368
• Other study ID #: T-10/27.02.2009
• Status: Unknown status
• Phase: Phase 3
• First received: July 15, 2009
• Last updated: July 24, 2009
• Start date: June 2009
• Est. completion date: January 2010

Study information

• Verified date: July 2009
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: Anu K, BScNursing
• Phone: 9109891661848
• Email: anukaiims[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 60
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nausea
• Vomiting

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
India	Dr. B.R. Ambedkar Institute Rotary Cancer Hospital	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, New Delhi

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in the Incidence and Severity of Chemotherapy Induced Nausea and Vomiting		6 months