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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by All India Institute of Medical Sciences, New Delhi.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT00940368
First received: July 15, 2009
Last updated: July 24, 2009
Last verified: July 2009

July 15, 2009
July 24, 2009
June 2009
December 2009   (final data collection date for primary outcome measure)
Reduction in the Incidence and Severity of Chemotherapy Induced Nausea and Vomiting [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00940368 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study to Assess the Anti-Emetic Efficacy of Ginger in Children and Adolescents Receiving Chemotherapy
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Health Services Research
  • Nausea
  • Vomiting
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.

Other Name: Tulsi Ayurvedic Products & Research(P)LTd,U.P.,India
  • Experimental: 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

    Intervention: Dietary Supplement: Provision of capsules containing ginger powder or placebo
  • Placebo Comparator: 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

    Intervention: Dietary Supplement: Provision of capsules containing ginger powder or placebo
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. Epub 2010 Sep 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
January 2010
December 2009   (final data collection date for primary outcome measure)

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.
Both
8 Years to 21 Years
No
Contact: Anu K, BScNursing 9109891661848 anukaiims@gmail.com
Contact: Kamlesh K Sharma, MScNursing
India
 
NCT00940368
T-10/27.02.2009
Yes
Anu K, AIIMS
All India Institute of Medical Sciences, New Delhi
Not Provided
Principal Investigator: Anu K, BSc.Nursing All India Institute of Medical Sciences, New Delhi
Study Director: Kamlesh K Sharma, MSc.Nursing All India Institute of Medical Sciences, New Delhi
Study Chair: Sameer Bakhshi, MD All India Institute of Medical Sciences, New Delhi
Study Chair: Y K Gupta, MD,FAMS,FIPS All India Institute of Medical Sciences, New Delhi
All India Institute of Medical Sciences, New Delhi
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP