Homeopathic Treatment of Fatigue in Children Receiving Chemotherapy

NCT01662076 | Completed Phase 3

• 1 other identifier: 1000027444
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Cancer; Fatigue; Chemotherapy; Pediatrics; Homeopathy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Feasibility of administration

  14 days

• Changes in fatigue

  Change from baseline to 14 days

• Changes in quality of life

  Change from baseline to 14 days

Study Arms (1)

Sublingual or Oral Liquid Homeopathy

EXPERIMENTAL

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

Interventions

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).

Sublingual or Oral Liquid Homeopathy

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Previous history of allergy to the homeopathic products

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Neoplasms; Fatigue

Interventions

Materia Medica

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• Lillian Sung, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: August 2, 2012
• First Posted: August 10, 2012
• Study Start: August 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 20, 2015

Record last verified: 2015-05

Locations

CA (1)