Know Cancer

forgot password

A Randomized, Four-Arm Study Comparing Reiki, Yoga, Meditation, or Patient Education Group for Addressing Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)

18 Years
90 Years
Not Enrolling
Peripheral Neuropathy

Thank you

Trial Information

A Randomized, Four-Arm Study Comparing Reiki, Yoga, Meditation, or Patient Education Group for Addressing Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)

Chemotherapy-induced peripheral neuropathy (CIPN) is a side effect that occurs with many of
the most common chemotherapeutic agents used to treat cancer. Typically, CIPN is experienced
as tingling, burning, numbness, or pain in the upper and lower extremities and other parts
of the body. Severity of symptoms can range from bothersome to disabling and can have
profoundly negative effects on quality of life. Although the specific incidence or
prevalence of CIPN is unknown, it is generally estimated at 30 to 40 percent in patients who
have received the classes of chemotherapeutic agents used to treat breast, colon, and lung,
cancers, and lymphomas. There are no treatments or drugs that consistently ameliorate or
lead to the reversal of CIPN symptoms.Typically, symptoms of CIPN are considered along with
other pain symptoms and treated with opioids and analgesics. Additionally, the prescription
of anticonvulsant medications and tricyclic antidepressants can help alleviate neuropathic
pain. While these strategies can provide relief from cancer-related pain, they often yield
limited results for symptoms of CIPN. With few allopathic treatment alternatives for
attenuating the symptoms of CIPN, people living with these symptoms have few options other
than to endure them.

Unlike treatments based upon nociceptive and neuropathic models of pain that regard the pain
response as the outcome of a finite and mechanistic chain of biochemical events,
complementary treatments acknowledge the interpenetrating nature of the relationships
between body, mind, and spirit. Typically, complementary or integrative health strategies
incorporate psychological, emotional, and spiritual elements along with biochemical
strategies when addressing pain. Of particular interest in the proposed pilot study are
complementary techniques that include Yoga, Meditation, and Reiki.

Utilizing a pretest-posttest control group design with random assignment, this four-arm
experimental pilot study will be undertaken to determine the feasibility of three
complementary approaches in reducing the signs and symptoms of CIPN. This design was chosen
for its ability to support causal inference while managing threats to internal and external
design validity. The use of random assignment in the development of intervention and
comparison groups will strengthen the ability of this design to manage threats to internal
validity more efficiently. This pilot study involves the collection of quantitative data
from self-administered instruments that have been designed to measure health related quality
of life, symptoms of neurotoxicity, psychological distress, and mindfulness.

Inclusion Criteria:

- participants must be of at least 18 years of age,

- participants must have persistent symptoms of CIPN resulting from treatment with
vinca alkaloid, taxane, platinum class chemotherapies or immunomodulators
(Thalidomide) or antineoplastic agents (Velcade) for a known cancer diagnosis

- participants must have completed chemotherapy at least three months prior to
beginning the study,

- participants cannot concurrently receive chemotherapy treatment for cancer, nor

- actively take part in one of the complementary modalities offered in this pilot

- participants will be required to have an ability to comfortably speak, read, and
understand English.

- participants must be fully oriented and possess the capacity to understand and
provide informed consent for participation in the study.

Exclusion Criteria:

- failure to meet any one of the inclusion criteria

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Outcome Measure:

FACT GOG-ntx scale

Outcome Description:

This scale measures two outcomes:symptoms of neurotoxicity and quality of life. The FACT GOG-ntx combines the 27-item general Functional Assessment of Cancer Therapy scale (FACT-G) with an 11-item neurotoxicity subscale. Completion of the FACT-G does not require assistance and can be completed in less than five minutes. Cronbach's coefficient for each item on this scale has been demonstrated at 0.70 or higher, and the instrument is sensitive to respondent changes over time.

Outcome Time Frame:

change from baseline in quality of life and symptoms of neurotoxicity in 6 weeks

Safety Issue:


Principal Investigator

Paul G Clark, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

George Mason University


United States: Institutional Review Board

Study ID:




Start Date:

May 2010

Completion Date:

March 2012

Related Keywords:

  • Peripheral Neuropathy
  • chemotherapy induced peripheral neuropathy
  • cancer
  • psychological distress
  • mindfulness
  • complementary and alternative
  • Peripheral Nervous System Diseases
  • Demyelinating Diseases
  • Polyneuropathies
  • Nerve Compression Syndromes
  • Neurologic Manifestations
  • Neurotoxicity Syndromes



Life with Cancer Family CenterFairfax, Virginia  22031