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

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

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.

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

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: An N-of-1 Study of Homeopathic Treatment of Fatigue in Patients Receiving Chemotherapy
• Study Start Date: December 2013
• Actual Primary Completion Date: August 2015
• Actual Study Completion Date: September 2015

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

Canada, Ontario

Ottawa Integrative Cancer Centre

Ottawa, Ontario, Canada, K1Y2E5

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

• Responsible Party: The Canadian College of Naturopathic Medicine
• ClinicalTrials.gov Identifier: NCT01983592 History of Changes
• Other Study ID Numbers: 194318
• First Posted: November 14, 2013
• Last Update Posted: January 27, 2016
• Last Verified: January 2016

Keywords provided by The Canadian College of Naturopathic Medicine:

Homeopathy; Fatigue; Chemotherapy; Cancer

Additional relevant MeSH terms:

Fatigue; Signs and Symptoms