Skip to main content
OpenTrials
Completed

NCT Number: NCT01662076

Homeopathic Treatment of Fatigue in Children Receiving Chemotherapy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cancer Fatigue Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Homeopathic Remedies

Other

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 10, 2012
Registry last updated
May 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.