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
  Purpose

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.


Condition Intervention Phase
Nausea
Vomiting
Dietary Supplement: Provision of capsules containing ginger powder or placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • Reduction in the Incidence and Severity of Chemotherapy Induced Nausea and Vomiting [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2009
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
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

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

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

Ages Eligible for Study:   8 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00940368

Contacts
Contact: Anu K, BScNursing 9109891661848 anukaiims@gmail.com
Contact: Kamlesh K Sharma, MScNursing

Locations
India
Dr. B.R. Ambedkar Institute Rotary Cancer Hospital Recruiting
New Delhi, Delhi, India, 110049
Contact: Anu K, BSc. Nursing    9109891661848    anukaiims@gmail.com   
Contact: Kamlesh K Sharma, MSc. Nursing    91098911336985    kamlesh_con@yahoo.co.in   
Principal Investigator: Anu K, BSc. Nursing         
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
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
  More Information

No publications provided by All India Institute of Medical Sciences, New Delhi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anu K, AIIMS
ClinicalTrials.gov Identifier: NCT00940368     History of Changes
Other Study ID Numbers: T-10/27.02.2009
Study First Received: July 15, 2009
Last Updated: July 24, 2009
Health Authority: India: Institutional Review Board

Keywords provided by All India Institute of Medical Sciences, New Delhi:
Nausea
Vomiting
Chemotherapy

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Antiemetics
Emetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents

ClinicalTrials.gov processed this record on August 19, 2014