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.