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

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01983592
• Other study ID #: 194318
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 7, 2013
• Last updated: January 26, 2016
• Start date: December 2013
• Est. completion date: September 2015

Study information

• Verified date: January 2016
• Source: The Canadian College of Naturopathic Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Effects of Chemotherapy
• Fatigue

Intervention

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.
• Unmedicated lactose/sucrose globule

Locations

Country	Name	City	State
Canada	Ottawa Integrative Cancer Centre	Ottawa	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
The Canadian College of Naturopathic Medicine	Canadian CAM Research Fund, Ottawa Integrative Cancer Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 days	No
Secondary	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.	7 days	No