Colon Cancer Clinical Trial
Official title:
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
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.
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.
Aims
In light of the lack of studies examining the effects of wheatgrass consumption on immune
and well-being measures, as well as limited data from few studies regarding the effects of
biofeedback-assisted relaxation on immune parameters, the aims of the current study are as
follow:
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
Cooperative Oncology Group (ECOG) performance status of ≤ 2 and disease stage II or III, who
receive adjuvant chemotherapy of Capecitabine (Xeloda) or FU-5 treatment, conjoined with
Oxaliplatin, or Capecitabine 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 (The Regression Model requires 50 participants + 8 participants for each variable).
Possible parameters that will be monitored using the regression analysis will be: age,
gender, blood Albumin level, morbidity (including: diabetes, hypertension, heart disease,
stroke, arthritis), optimism and control perception. 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. Due to the large number of background parameters
that can be potential confounding variables, only parameters with significant association to
the dependent variables will be included. In the univariate statistical analysis, analysis
of variance (ANOVA) will be conducted in order to compare the study groups. In addition, a
comparison of outcome parameters before and after the intervention period will be conducted
using paired t-tests and Repeated measure analysis. As the calculated sample size and the
statistical power are sufficient for the regression analysis (multivariate statistical
analysis), they are also suitable for the univariate statistical analysis.
Following recruitment, participants will be randomly divided into 2 intervention groups:
biofeedback-assisted relaxation or wheatgrass consumption. The control group will consist of
subjects who were not interested in participating in the active intervention, but agreed to
contribute blood samples during chemotherapy treatments for the purpose of the study. This
study design was selected as expected recruitment rate will not allow for a random
allocation for test and control groups. However, this control will enable us to compare
immune parameters of patients who refused to participate in this study, with those who were
allocated to each group, in order to neutralize the effect of the oncology treatment and to
compare the groups. In addition, each treatment group can be evaluated for immune and
well-being parameters, each subject's pre-treatment status serving as a control for his
post-treatment status.
Blood samples will be collected at baseline (the onset of chemotherapy), and then again 3
and 6 months later for measuring the levels of cytokines (IL-6, IL-8, IL-10, IL-12) in the
serum and in micro-particles. Well-being will be assessed at the same 3 time points via
questionnaires, including emotional and physical symptoms: anxiety, depression, pain, nausea
and vomiting, and chronic fatigue levels. Demographical and medical information will be
taken from the medical records. The two study interventions will continue for 6 months (the
chemotherapy treatment period). (1) Biofeedback-assisted relaxation intervention group:
participants will receive biofeedback devices to practice relaxation at home. Four sessions
will be conducted with a psychologist specializing in biofeedback therapy. During these
sessions, relaxation techniques will be learned and practiced. (2) Wheatgrass intervention
group: Each patient will be supplied with frozen wheatgrass juice divided into daily doses
of 60 cc. Patients will be asked to drink one dose every morning on an empty stomach.
Study importance and potential contribution This is a first study to examine the possible
effects of biofeedback-assisted relaxation vs. wheatgrass juice on immune and well-being
parameters among colorectal cancer patients. To the best of our knowledge, this is the first
study to investigate the possible effects of biofeedback-assisted relaxation on serum levels
of the pro-inflammatory cytokines. Using a randomized controlled design with three time
points and a homogenous sample in terms of disease parameters, type of treatment and
functional status will allow us to obtain valid results regarding the psychological and
physical parameters of well-being and pro-inflammatory biomarkers. Possible verification of
the study hypotheses will add to the theoretical knowledge on the effects of personal
resources and psychological well-being on immune measures and may suggest potential ways to
improve well-being as well as cancer-related symptoms, and even disease course among
colorectal cancer patients
;
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