Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2025-12-27 @ 9:38 PM
Study NCT ID:
NCT01983592
Status:
COMPLETED
Last Update Posted:
2016-01-27
First Post:
2013-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An N-of-1 Study of Homeopathic Treatment of Fatigue in Patients Receiving Chemotherapy
Sponsor:
The Canadian College of Naturopathic Medicine
Organization:
Study Overview
Official Title:
An N-of-1 Study of Homeopathic Treatment of Fatigue in Patients Receiving Chemotherapy
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: