NCT01983592

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: The Canadian College of Naturopathic Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-08-01
• Completion: 2015-09-01
• First posted: 2013-11-14
• Last updated: 2016-01-27

Locations

1 site across 1 country: Canada