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

Primary Purpose

Fatigue, Effects of Chemotherapy

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Homeopathic medicine
Unmedicated lactose/sucrose globule
Sponsored by
The Canadian College of Naturopathic Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatigue focused on measuring Homeopathy, Fatigue, Chemotherapy, Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ottawa Integrative Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Homeopathic medicine

Unmedicated lactose/sucrose globule

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Multidimensional Fatigue Inventory (MFI)
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
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.

Full Information

First Posted
November 7, 2013
Last Updated
January 26, 2016
Sponsor
The Canadian College of Naturopathic Medicine
Collaborators
Canadian CAM Research Fund, Ottawa Integrative Cancer Centre
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1. Study Identification

Unique Protocol Identification Number
NCT01983592
Brief Title
An N-of-1 Study of Homeopathic Treatment of Fatigue in Patients Receiving Chemotherapy
Official Title
An N-of-1 Study of Homeopathic Treatment of Fatigue in Patients Receiving Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Canadian College of Naturopathic Medicine
Collaborators
Canadian CAM Research Fund, Ottawa Integrative Cancer Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Effects of Chemotherapy
Keywords
Homeopathy, Fatigue, Chemotherapy, Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Homeopathic medicine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Unmedicated lactose/sucrose globule
Arm Type
Placebo Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Homeopathic medicine
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Unmedicated lactose/sucrose globule
Primary Outcome Measure Information:
Title
Multidimensional Fatigue Inventory (MFI)
Description
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.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
EORTC-QLQ-C30
Description
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.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dugald Seely, ND
Organizational Affiliation
Canadian College of Naturopathic Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ottawa Integrative Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y2E5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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