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NCT Number: NCT01983592

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

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.

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Key information

Conditions

Fatigue Effects of Chemotherapy Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Ottawa Integrative Cancer Centre

Ottawa, Ontario, K1Y2E5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Unmedicated lactose/sucrose globule

Other

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

The Canadian College of Naturopathic Medicine

Other

Collaborators

  • Canadian CAM Research Fund
  • Ottawa Integrative Cancer Centre

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 14, 2013
Registry last updated
Jan 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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