Clinical trial NCT01569269: Effects of Reiki, Yoga, Meditation, on the Physical and Psychological Symptoms of Chemotherapy-Induced Peripheral Neuropathy
Official title: A Randomized, Four-Arm Study Comparing Reiki, Yoga, Meditation, or Patient Education Group for Addressing Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Neuropathy
Keywords: chemotherapy induced peripheral neuropathy
cancer
psychological distress
mindfulness
complementary and alternative
Lead sponsor: George Mason University
Sponsor class: OTHER
First posted: 2012-04-03
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to test whether people with symptoms of chemotherapy-induced peripheral neuropathy (CIPN) receive physical or psychological benefits from participating in a six-week Reiki, Yoga, Meditation, or Educational experience.

Detailed description: 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.

Eligibility criteria: 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 study.
* 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

Primary outcomes:
measure: FACT GOG-ntx scale
timeFrame: change from baseline in quality of life and symptoms of neurotoxicity in 6 weeks
Secondary outcomes:
measure: The Brief Symptom Inventory - 18 (BSI-18)
timeFrame: change from baseline in quality of life and symptoms of neurotoxicity in 6 weeks
measure: Mindful Attention Awareness scale (MAAS)
timeFrame: change from baseline in quality of life and symptoms of neurotoxicity in 6 weeks
Other outcomes:
Locations:
city: Fairfax
country: United States
facility: Life with Cancer Family Center
state: Virginia
Study officials:
affiliation: George Mason University
name: Paul G Clark, PhD
role: PRINCIPAL_INVESTIGATOR
References: