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Clinical Trials/NCT01991080
NCT01991080UnknownNot Applicable

Examining the Relationship Between Relaxation Combined With Biofeedback or Wheat Germ Juice to the Immune Indices and Quality of Life Measures in Patients With Colorectal Cancer Who Receive Prophylactic Chemotherapy After Surgery

Rambam Health Care Campus1 site in 1 country200 target enrollmentStarted: December 2013Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Enrollment
200
Locations
1
Primary Endpoint
Primary Outcome

Study Overview

Brief Summary

The immune system plays an important role in the fight against cancer. According to certain studies, Levels of cytokines secreted by the immune cells were found as predictors of prognosis and survival among cancer patients, as well as disease recurrence. Previous studies, including meta-analyses, reported that chronic emotional stress or depression were associated with higher levels of pro-inflammatory cytokines. Practicing relaxation was found to decrease psychological symptoms among cancer patients, such as depression, anger, hostility and anxiety symptoms, as well as physical symptoms.

Wheatgrass juice is an extract squeezed from the mature sprouts of wheat seeds (Triticum aestivum). Currently, there are only a few laboratory and medical studies that examine the beneficial effects of wheatgrass consumption. Controlled clinical trials have found that wheatgrass juice may reduce chemotherapy-induced myelotoxicity, accompanied by fever and infection without harming the chemotherapy effectiveness among breast cancer patients6.

Aims

  1. To examine the differences in immune measures (serum and micro-particles levels of the cytokines IL-6, IL-8, IL-10 and IL-12), and in physical and psychological well-being measures (anxiety, depression, pain, fatigue, nausea) at three time points and between two intervention methods (biofeedback-assisted relaxation and wheatgrass consumption) and between the intervention groups vs. a control group, among colorectal cancer patients.
  2. To assess the mediating role of optimism, perceived control and well-being measures (anxiety, depression, pain, fatigue, nausea) among colorectal cancer patients in the relations between the interventions (biofeedback-assisted relaxation and wheatgrass consumption) and the immune measures (serum and micro-particles levels of cytokines IL-6, IL-8 IL-10 and IL-12 ), and the mediating role of well-being measures on the relations between optimism and perceived control with immune measures.

Methods Participants will include 120 colorectal cancer patients aged 18+, with Eastern performance status of ≤ 2 and disease stage II or III, who receive adjuvant chemotherapy of Capcitabine or FU-5 treatment, conjoined with Oxaliplatin, or Capcitabine alone following curative surgery at Rambam Health Care Campus. The estimated number of participants was calculated based on Green's equation (1991): 50+8X 7 A comparison between the two treatment groups, as well as a comparison between each treatment group and the control group (80 subjects) will allow inclusion of up to four background parameters in each of the regressions, according to Green's equation.

Detailed Description

The immune system plays an important role in the fight against cancer. According to certain studies, Levels of cytokines secreted by the immune cells were found as predictors of prognosis and survival among cancer patients, as well as disease recurrence1. Pro-inflammatory cytokines, such as IL-6, IL-8 and IL-10 were found to be negative prognostic factors in different cancer types, including colorectal cancer, while IL-12 was found in several studies to be a positive prognostic factor. However, inconclusive results were found for the role of IL-12 and anti-inflammatory cytokines in cancer prognosis.

Previous studies, including meta-analyses, reported that chronic emotional stress or depression were associated with higher levels of pro-inflammatory cytokines2; furthermore, there is some, albeit inconclusive, evidence that they may predict lower survival rates3. Moreover, there is further evidence that personal resources such as optimism and control perceptions may have an effect on psychological and physical well-being (i.e., low level of psychological or physical symptoms in reaction to stressful events) and dysregulate immune functions such as levels of pro-inflammatory cytokines.

Practicing relaxation was found to decrease psychological symptoms among cancer patients, such as depression, anger, hostility and anxiety symptoms, as well as physical symptoms, including fatigue, insomnia and pain. In addition, relaxation may reduce nausea and vomiting following chemotherapy.

Several studies of cancer patients have reported positive associations between relaxation-based interventions and immune measures, such as an elevated rate of T-cell subpopulations as well as increased IL-4 production and decreased IL-10 production4. Similarly, biofeedback-assisted relaxation was associated with enhanced natural killer cell activity, lymphocyte responsiveness, and the number of peripheral blood lymphocytes5. However, results are not always conclusive, and the few studies investigating the relationship between relaxation training and immune measures have often included small and uncontrolled samples.

Wheatgrass juice is an extract squeezed from the mature sprouts of wheat seeds (Triticum aestivum). Currently, there are only a few laboratory and medical studies that examine the beneficial effects of wheatgrass consumption. These studies tend to report positive effects with minimal side effects among patients with arthritis, thalassemia and ulcerative colitis. Lab research has demonstrated that wheatgrass consumption caused a prolonged latent period of skin cancer in mice. Controlled clinical trials have found that wheatgrass juice may reduce chemotherapy-induced myelotoxicity, accompanied by fever and infection without harming the chemotherapy effectiveness among breast cancer patients6.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •colon cancer patients receiving adjuvant treatment as described above after hysterectomy surgery.
  • •stage II or III disease
  • •age over 18 years.
  • •functional status (PS) ≤ 2 (0-2 WHO performance status)
  • •patients hospital Rambam Medical Center
  • •signing of the informed consent form

Exclusion Criteria

  • •patients taking psychiatric drugs because of depression, anxiety or another disorder that requires psychiatric intervention.
  • •comorbidity that directly affects the immune indices (such as autoimmune diseases, immune deficiency)
  • •difficulty in understanding the Hebrew language-these patients can be included in the control group

Arms & Interventions

Biofeedback

Active Comparator

The patients will undergo biofeedback relaxation therapy

Intervention: Wheatgerm juice (Drug)

Biofeedback

Active Comparator

The patients will undergo biofeedback relaxation therapy

Intervention: biofeedback (Behavioral)

Wheatgerm juice

Active Comparator

patients will drink Wheatgerm juice

Intervention: biofeedback (Behavioral)

Wheatgerm juice

Active Comparator

patients will drink Wheatgerm juice

Intervention: Wheatgerm juice (Drug)

Outcomes

Primary Outcomes

Primary Outcome

Time Frame: six months or end of adjuvant chemotherapy

1.The differences in the level of the inflammatory cytokines IL-6, 8-6, IL10, IL-12, in serum and microparticles. between two methods of intervention (relaxation in combination with biofeedback or wheatgrass juice consumption) or control group of patients with colorectal cancer under chemotherapy adjuvant treatment.

Secondary Outcomes

  • Secondary(six months or end of adjuvant chemotherapy treatment)
  • secondary(Six months or end of adjuvant chemotherapy)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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