Clinical trial NCT00940368: A Study to Assess the Anti-Emetic Efficacy of Ginger in Children and Adolescents Receiving Chemotherapy
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Nausea
Vomiting
Keywords: Nausea
Vomiting
Chemotherapy
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2009-07-16
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Reduction in the Incidence and Severity of Chemotherapy Induced Nausea and Vomiting
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Dr. B.R. Ambedkar Institute Rotary Cancer Hospital
state: Delhi
Study officials:
affiliation: All India Institute of Medical Sciences
name: Anu K, BSc.Nursing
role: PRINCIPAL_INVESTIGATOR
affiliation: All India Institute of Medical Sciences
name: Kamlesh K Sharma, MSc.Nursing
role: STUDY_DIRECTOR
affiliation: All India Institute of Medical Sciences
name: Sameer Bakhshi, MD
role: STUDY_CHAIR
affiliation: All India Institute of Medical Sciences
name: Y K Gupta, MD,FAMS,FIPS
role: STUDY_CHAIR
References:
citation: 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.