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

NCT01983592 | Completed Phase 1

• 1 other identifier: 194318
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatigue; Effects of Chemotherapy

Keywords

Homeopathy; Fatigue; Chemotherapy; Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• EORTC-QLQ-C30

  7 days

Study Arms (2)

Homeopathic medicine

ACTIVE COMPARATOR

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

Unmedicated lactose/sucrose globule

PLACEBO COMPARATOR

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

Interventions

Homeopathic medicine 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.

Homeopathic medicine

Unmedicated lactose/sucrose globule OTHER

Unmedicated lactose/sucrose globule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Previous history of allergy to the homeopathic products.
• Pregnant or lactating

Sponsors & Collaborators

• The Canadian College of Naturopathic Medicine: lead
• Canadian CAM Research Fund: collaborator
• Ottawa Integrative Cancer Centre: collaborator

Study Sites (1)

Ottawa Integrative Cancer Centre

Ottawa, Ontario, K1Y2E5, Canada

Location

MeSH Terms

Conditions

Fatigue; Neoplasms

Interventions

Homeopathy

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Dugald Seely, ND

  Canadian College of Naturopathic Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2013
• First Posted: November 14, 2013
• Study Start: December 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 27, 2016

Record last verified: 2016-01

Locations

CA (1)