Clinical trial NCT01662076: Homeopathic Treatment of Fatigue in Children Receiving Chemotherapy
Official title: A Feasibility Pilot Trial of Individualized Homeopathic Treatment of Fatigue in Children Receiving Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer
Keywords: Cancer
Fatigue
Chemotherapy
Pediatrics
Homeopathy
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2012-08-10
Enrollment: 9
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of recruitment
timeFrame: baseline
Secondary outcomes:
measure: Feasibility of administration
timeFrame: 14 days
measure: Changes in fatigue
timeFrame: Change from baseline to 14 days
measure: Changes in quality of life
timeFrame: Change from baseline to 14 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Lillian Sung, MD
role: PRINCIPAL_INVESTIGATOR
References: