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

The Canadian College of Naturopathic Medicine

Status and phase: Completed; Phase 2; Phase 1

Conditions: Effects of Chemotherapy; Fatigue

Treatments: Other: Unmedicated lactose/sucrose globule; Other: Homeopathic medicine

Study type: Interventional

Funder types: Other

Identifiers

NCT01983592

194318

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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1 participants in 2 patient groups, including a placebo group

Homeopathic medicine

Active Comparator group

Description:

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.

Treatment:

Other: Homeopathic medicine

Unmedicated lactose/sucrose globule

Placebo Comparator group

Description:

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.

Treatment:

Other: Unmedicated lactose/sucrose globule