Homeopathic Treatment of Fatigue in Children Receiving Chemotherapy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Lillian Sung, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01662076
First received: August 2, 2012
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Cancer
Other: Homeopathic Remedies
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Feasibility Pilot Trial of Individualized Homeopathic Treatment of Fatigue in Children Receiving Chemotherapy

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Feasibility of recruitment [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Feasibility of administration [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To describe changes in generic and cancer specific quality of life as measured by the PedsQL Generic Core Scales and Acute Cancer Module


Estimated Enrollment: 10
Study Start Date: August 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01662076

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Lillian Sung, MD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Lillian Sung, Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01662076     History of Changes
Other Study ID Numbers: 1000027444
Study First Received: August 2, 2012
Last Updated: May 15, 2014
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
Cancer
Fatigue
Chemotherapy
Pediatrics
Homeopathy

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014