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

NCT ID: NCT01983592

Last Updated: 2016-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-09-30

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.

Conditions

Fatigue; Effects of Chemotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Homeopathic medicine

Intervention Type: OTHER

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

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.

Group Type: PLACEBO_COMPARATOR

Unmedicated lactose/sucrose globule

Intervention Type: OTHER

Interventions

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.

Intervention Type: OTHER

Unmedicated lactose/sucrose globule

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian CAM Research Fund

UNKNOWN

Sponsor Role: collaborator

Ottawa Integrative Cancer Centre

UNKNOWN

Sponsor Role: collaborator

The Canadian College of Naturopathic Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dugald Seely, ND

Role: PRINCIPAL_INVESTIGATOR

Canadian College of Naturopathic Medicine

Locations

Ottawa Integrative Cancer Centre

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

194318

Identifier Type: -

Identifier Source: org_study_id