The Effect of Ganoderma on Patients With Head-and-neck Cancer

Head-and-neck Cancer Clinical Trial

Official title:

The Effect of Gandoerma Spores Powder Capsules on the Post-treatment Life Quality and Immune Modulation of the Patients With Head-and-neck Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02238587
• Other study ID #: 1020304
• Status: Recruiting
• Phase: N/A
• First received: September 8, 2014
• Last updated: September 9, 2014
• Start date: June 2014
• Est. completion date: May 2015

Study information

• Verified date: September 2014
• Source: Chang Bing Show Chwan Memorial Hospital
• Contact: Ching-Yeh Hsiung
• Phone: 886-975617327
• Email: hsiungcy[@]hotmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

To study the effect of Ganoderma Spores Powder Capsules on the life quality and immunity status of the patients with head-and-neck cancer after complete treatment (including surgery and / or radiotherapy and/or chemotherapy)

Description:

Ganoderma is known to modulate immunity and improve health. However, the mechanism is not clear. We hypothesize that patients who have completed standard treatment with/without radiotherapy might require biological modifier such as Ganoderma to improve life quality and immunity status.

A total of 100 patients are randomized to study and control groups. In study group, Ganoderma Spores Powder Capsules are given to the patients for 6 weeks, In control group, only placebos are given during the same period. Then the patients in study and control groups are switched, Ganoderma Spores Powder Capsules and placebos are given for 6 weeks. The data pertaining to their Life quality are collected using Quality of Life Questionnaire after the first 6 weeks and the second 6 weeks. The immunity status is also studied at the same time.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with head-and-neck cancer after complete treatment for at least 3 months (including surgery and/or radiotherapy and/or chemotherapy)

Exclusion Criteria:

• Patients with head-and-neck cancer under treatment or within 3 months after treatment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Head-and-neck Cancer

Intervention

Other:
• Control group
In control group, only placebos are given for 6 weeks. The patients who are in control groups are switched to receive Ganoderma Spores Powder Capsules for 6 weeks.

Dietary Supplement:
• Ganoderma Spores Powder Capsules
In experimental group, Ganoderma Spores Powder Capsules for 12 weeks.

Locations

Country	Name	City	State
Taiwan	Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital	Changhua County

Sponsors (1)

Lead Sponsor	Collaborator
Chang Bing Show Chwan Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immune modulation such as tumor necrosis factors-a or interleukin-6	Subjects will be assigned to receive placebo/Ganoderma or Ganoderma Spores Powder Capsules twice a day for 12 weeks. Peripheral blood and saliva will be collected at 3 different times: (1)baseline data: before oral intervention, (2)outcome data: at 6 and 12 weeks post-oral intervention.	Change from baseline in cytokines at 6 months	No
Secondary	Life quality	Health and life quality will assessed by Quality of Life Questionnaire at three different times: (1)baseline data: before intervention, (2)outcome data: at 6 and 12 weeks post-oral intervention.	Change from baseline in life quality at 6 months	No