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

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ClinicalTrials.gov Identifier: NCT01983592
Recruitment Status : Completed
First Posted : November 14, 2013
Last Update Posted : January 27, 2016
Sponsor:
Collaborators:
Canadian CAM Research Fund
Ottawa Integrative Cancer Centre
Information provided by (Responsible Party):
The Canadian College of Naturopathic Medicine

Tracking Information
First Submitted Date  ICMJE November 7, 2013
First Posted Date  ICMJE November 14, 2013
Last Update Posted Date January 27, 2016
Study Start Date  ICMJE December 2013
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2013)
Multidimensional Fatigue Inventory (MFI) [ Time Frame: 7 days ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01983592 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2013)
EORTC-QLQ-C30 [ Time Frame: 7 days ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An N-of-1 Study of Homeopathic Treatment of Fatigue in Patients Receiving Chemotherapy
Official Title  ICMJE An N-of-1 Study of Homeopathic Treatment of Fatigue in Patients Receiving Chemotherapy
Brief Summary

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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Fatigue
  • Effects of Chemotherapy
Intervention  ICMJE
  • 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.
  • Other: Unmedicated lactose/sucrose globule
Study Arms  ICMJE
  • 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.
    Intervention: Other: Homeopathic medicine
  • 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.
    Intervention: Other: Unmedicated lactose/sucrose globule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 13, 2013)
1
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01983592
Other Study ID Numbers  ICMJE 194318
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The Canadian College of Naturopathic Medicine
Study Sponsor  ICMJE The Canadian College of Naturopathic Medicine
Collaborators  ICMJE
  • Canadian CAM Research Fund
  • Ottawa Integrative Cancer Centre
Investigators  ICMJE
Principal Investigator: Dugald Seely, ND Canadian College of Naturopathic Medicine
PRS Account The Canadian College of Naturopathic Medicine
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP