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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


Phase 3
8 Years
21 Years
Open (Enrolling)
Both
Nausea, Vomiting

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research

Outcome Measure:

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

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Anu K, BSc.Nursing

Investigator Role:

Principal Investigator

Investigator Affiliation:

All India Institute of Medical Sciences, New Delhi

Authority:

India: Institutional Review Board

Study ID:

T-10/27.02.2009

NCT ID:

NCT00940368

Start Date:

June 2009

Completion Date:

January 2010

Related Keywords:

  • Nausea
  • Vomiting
  • Nausea
  • Vomiting
  • Chemotherapy
  • Nausea
  • Vomiting

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