The Relationship Between Relaxation or Wheat Germ Juice to the Immune Indices and Quality of Life (QoL) in Colorectal Cancer Patients on Adjuvant Chemotherapy

NCT01991080 | Unknown

• 1 other identifier: Biofeedback
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Colon Cancer

Keywords

biofeedback; relaxation; Wheat germ juice

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

  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.

  six months or end of adjuvant chemotherapy

Secondary Outcomes (3)

• Secondary

  six months or end of adjuvant chemotherapy treatment

• secondary

  six months or end of adjuvant chemotherapy

• secondary

  Six months or end of adjuvant chemotherapy

Study Arms (2)

Wheatgerm juice

ACTIVE COMPARATOR

patients will drink Wheatgerm juice

Behavioral: biofeedback; Drug: Wheatgerm juice

Biofeedback

ACTIVE COMPARATOR

The patients will undergo biofeedback relaxation therapy

Behavioral: biofeedback; Drug: Wheatgerm juice

Interventions

biofeedback BEHAVIORAL

Patients will go through biofeedback sessions

Also known as: Patients will go through biofeedback sessions

Biofeedback; Wheatgerm juice

Wheatgerm juice DRUG

Patient will drink wheatgerm juice

Also known as: Patient will drink wheatgerm juice

Biofeedback; Wheatgerm juice

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 Center6. signing of the informed consent form

You may not qualify if:

• 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)3. difficulty in understanding the Hebrew language-these patients can be included in the control group

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Oncology Institute, Rambam Health Care Campus

Haifa, 31096, Israel

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Gil Bar-Sela, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2013
• First Posted: November 25, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 8, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)