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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01983592
|Ottawa Integrative Cancer Centre|
|Ottawa, Ontario, Canada, K1Y2E5|
|Principal Investigator:||Dugald Seely, ND||Canadian College of Naturopathic Medicine|