Homeopathic Treatment of Fatigue in Children Receiving Chemotherapy
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|ClinicalTrials.gov Identifier: NCT01662076|
Recruitment Status : Completed
First Posted : August 10, 2012
Last Update Posted : May 20, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Other: Homeopathic Remedies||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Feasibility Pilot Trial of Individualized Homeopathic Treatment of Fatigue in Children Receiving Chemotherapy|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
Experimental: Sublingual or Oral Liquid Homeopathy
The homeopathic remedy will be administered as 1 lactose/sucrose globule 2.5 mm in diameter to be administered sublingually up to 3 times per day or as 0.2 ml of a 30% ethanol based liquid homeopathic remedy administered orally up to 3 times per day. The homeopathic remedy and/or the homeopathic remedy potency can be changed on a daily basis during the course of treatment. However, only one homeopathic remedy and potency will be administered at a given time.
Other: Homeopathic Remedies
The homeopathic remedy will be administered as either 1 globule sublingual or 0.2 mL oral (depending on chosen formulation) up to 3 times per day. The homeopath will decide which formulation will be used. Homeopathic remedies prepared according to the standards as set out by Health Canada. The caregiver or patient will be asked to administer the homeopathic remedy at least 30 minutes before or after taking other medications, food and strong smelling substances (such as camphor, mint, or coffee).
- Feasibility of recruitment [ Time Frame: baseline ]The primary objective is to determine the feasibility of recruiting patients for a study of individualized homeopathy in paediatric patients receiving chemotherapy for cancer.
- Feasibility of administration [ Time Frame: 14 days ]To determine the feasibility of administering individualized homeopathy in pediatric cancer patients receiving chemotherapy for cancer by describing the proportion of participants who complete at least 10 days of treatment
- Changes in fatigue [ Time Frame: Change from baseline to 14 days ]To describe changes in fatigue scores according to the Symptom Distress Scale (SDS) and the PedsQL Multidimension Fatigue Scale
- Changes in quality of life [ Time Frame: Change from baseline to 14 days ]To describe changes in generic and cancer specific quality of life as measured by the PedsQL Generic Core Scales and Acute Cancer Module
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01662076
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Principal Investigator:||Lillian Sung, MD||The Hospital for Sick Children|