Homeopathic Treatment of Fatigue in Children Receiving Chemotherapy

Cancer Clinical Trial

Official title:

A Feasibility Pilot Trial of Individualized Homeopathic Treatment of Fatigue in Children Receiving Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01662076
• Other study ID #: 1000027444
• Status: Completed
• Phase: Phase 3
• First received: August 2, 2012
• Last updated: May 19, 2015
• Start date: August 2012
• Est. completion date: May 2014

Study information

• Verified date: May 2015
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

Cancer-related fatigue has been described as a subjective feeling of physical, emotional, and/or cognitive tiredness. Fatigue is frequently identified as one of the most troublesome symptoms in pediatric cancer patients. Fatigue affects children with cancer throughout the trajectory of their disease. Treatment interventions for cancer-related fatigue have been largely unsuccessful. Homeopathy involves treatment of patients with diluted natural substances aimed at stimulating the body's healing system. In the efficacy trial literature, individualized homeopathy shows the most promise over other forms of homeopathic intervention. Individualized homeopathic treatment involves a unique yet established method of case taking. During the consultation, the homeopath asks a series of broad questions to elicit subjective symptoms related to the patient's disease, their medical history, as well as particular characteristics (physical or psychological) related to the individual. This study will recruit children receiving chemotherapy to undergo homeopathic remedies to treat their fatigue. This study hypothesizes that homeopathic treatment will effectively treat fatigue.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 18 Years

Eligibility

Inclusion Criteria:

• Diagnosed with any type of cancer. Patients may have newly diagnosed, relapsed or a second malignant disease.

• Receiving any type of chemotherapy administered intermittently (i.e. not continuous administration) with or without radiation treatment

• Discharge from SickKids is anticipated to occur following completion of the current inpatient chemotherapy or chemotherapy is being administered as an outpatient

• Between 2 and 18 years of age (age range for which instruments are available and children may be able to comply with homeopathy) A score on the Symptoms Distress Scale (SDS) of 2 or higher

• Able to ingest medications in lactose/sucrose globule or liquid form

• Reside within Greater Toronto area or willing to travel to the Riverdale Homeopathic Clinic. Participants living outside of the Greater Toronto area who wish to receive home visits may be eligible provided that permission is granted by the homeopath investigator

• A parent or caregiver must be able to read and write in English.

• Patients who are currently receiving CAM including homeopathy are eligible.

Exclusion Criteria:

• Previous history of allergy to the homeopathic products

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cancer

Intervention

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).

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of recruitment	The primary objective is to determine the feasibility of recruiting patients for a study of individualized homeopathy in paediatric patients receiving chemotherapy for cancer.	baseline	No
Secondary	Feasibility of administration	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	14 days	No
Secondary	Changes in fatigue	To describe changes in fatigue scores according to the Symptom Distress Scale (SDS) and the PedsQL Multidimension Fatigue Scale	Change from baseline to 14 days	No
Secondary	Changes in quality of life	To describe changes in generic and cancer specific quality of life as measured by the PedsQL Generic Core Scales and Acute Cancer Module	Change from baseline to 14 days	No