An N-of-1 Study of Homeopathic Treatment of Fatigue in Patients Receiving Chemotherapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by The Canadian College of Naturopathic Medicine
Sponsor:
Collaborators:
Canadian CAM Research Fund
Ottawa Integrative Cancer Centre
Information provided by (Responsible Party):
The Canadian College of Naturopathic Medicine
ClinicalTrials.gov Identifier:
NCT01983592
First received: November 7, 2013
Last updated: December 7, 2013
Last verified: December 2013
  Purpose

Fatigue is frequently identified as one of the most troublesome symptoms in cancer patients and there are very few conventional therapies which can address the symptom of fatigue in patients who are undergoing cancer treatment.

This study will be testing whether the administration of a complementary therapy (individualized homeopathy) to a patient undergoing chemotherapy treatment is feasible and whether this treatment can lessen the fatigue symptoms of adults. The study will also test whether the n-of-1 study design is feasible in this population.


Condition Intervention Phase
Fatigue
Effects of Chemotherapy
Other: Homeopathic medicine
Other: Unmedicated lactose/sucrose globule
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An N-of-1 Study of Homeopathic Treatment of Fatigue in Patients Receiving Chemotherapy

Resource links provided by NLM:


Further study details as provided by The Canadian College of Naturopathic Medicine:

Primary Outcome Measures:
  • Multidimensional Fatigue Inventory (MFI) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    The Multidimensional Fatigue Inventory (MFI) is a 20-item, multi-dimensional, self-report instrument designed to measure fatigue. It covers the following 5 dimensions: 1) General Fatigue, 2) Physical Fatigue, 3) Mental Fatigue, 4) Reduced Motivation and 5) Reduced Activity.


Secondary Outcome Measures:
  • EORTC-QLQ-C30 [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    The EORTC QLQ-C30 is a 30-item multi-dimensional questionnaire developed to assess the quality of life of cancer patients in the following four domains: functional scales; symptom scales; global quality of life; and single items.


Estimated Enrollment: 1
Study Start Date: December 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Homeopathic medicine
The study medication will be administered in one of two forms: (1) 3.5 mm diameter lactose/sucrose globule to be administered sublingually; or (2) 3.5 mm diameter lactose/sucrose globule dissolved in 250 ml spring water and administered orally. The medication will be administered as either 1 globule sublingual or 5 mL oral remedy/water up to 3 times per day. The dosage regimen is varialble at the discretion of the study clinician.
Other: Homeopathic medicine
Intervention must begin within 5 days of chemotherapy cycle completion. Intervention will continue until the next cycle of chemotherapy. The initial consultation will involve a verbal interview between the homeopath and the participant. The practitioner will then choose a single homeopathic remedy that will focus on the reduction of fatigue. Only one homeopathic remedy and potency will be administered at a given time. The participant will be asked to take the study medication at least 30 minutes before or after taking other medications, food and strong smelling substances.
Placebo Comparator: Unmedicated lactose/sucrose globule
The placebo will be administered in one of two forms: (1) 3.5 mm diameter lactose/sucrose globule to be administered sublingually; or (2) 3.5 mm diameter lactose/sucrose globule dissolved in 250 ml spring water and administered orally. The medication will be administered as either 1 globule sublingual or 5 mL oral remedy/water up to 3 times per day. The dosage regimen is varialble at the discretion of the study clinician.
Other: Unmedicated lactose/sucrose globule

Detailed Description:

This is an n-of-1 pilot trial of individualized homeopathic treatment of fatigue in a single adult who is undergoing any type of chemotherapy administered intermittently (i.e. not continuously). The participant will have a homeopathic consultation within 3 days of a round of chemotherapy ("treatment period") and will be administered either verum or placebo according to a binary randomization allocation sequence unknown to both the clinician and participant. During the subsequent treatment period the participant will be given the other allocation (verum or placebo). The following pairs of allocations will also be randomized with treatment continuing for as long as the participant is undergoing chemotherapy treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with any type of cancer. Patient may have newly diagnosed, relapsed or a second malignant disease.
  • Receiving any type of cytotoxic chemotherapy with 6 or more cycles post study enrollment administered intermittently every two or three weeks with no planned radiation treatment.
  • Is experiencing fatigue due to the chemotherapy treatments. (or has a score of 2 or higher on the fatigue item of the Symptom Distress Scale)
  • Above 18 years of age.
  • Able to ingest medications in lactose/sucrose globule or liquid form.

Exclusion Criteria:

  • Previous history of allergy to the homeopathic products.
  • Pregnant or lactating
  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: NCT01983592

Contacts
Contact: David Brule, Homeopath david.brule@utoronto.ca

Locations
Canada, Ontario
Ottawa Integrative Cancer Centre Recruiting
Ottawa, Ontario, Canada, K1Y2E5
Contact: Dugald Seely, ND       dseely@ccnm.edu   
Sub-Investigator: David Brule, Homeopath         
Sponsors and Collaborators
The Canadian College of Naturopathic Medicine
Canadian CAM Research Fund
Ottawa Integrative Cancer Centre
Investigators
Principal Investigator: Dugald Seely, ND Canadian College of Naturopathic Medicine
  More Information

No publications provided

Responsible Party: The Canadian College of Naturopathic Medicine
ClinicalTrials.gov Identifier: NCT01983592     History of Changes
Other Study ID Numbers: 194318
Study First Received: November 7, 2013
Last Updated: December 7, 2013
Health Authority: Canada: Health Canada

Keywords provided by The Canadian College of Naturopathic Medicine:
Homeopathy
Fatigue
Chemotherapy
Cancer

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014