NCT02238587

Brief 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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

September 12, 2014

Status Verified

September 1, 2014

Enrollment Period

11 months

First QC Date

September 8, 2014

Last Update Submit

September 9, 2014

Conditions

Head-and-neck Cancer

Keywords

Gandoerma Spores Powder Capsules, head-and-neck cancer.

Outcome Measures

Primary Outcomes (1)

  • Immune modulation such as tumor necrosis factors-α 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

Secondary Outcomes (1)

  • Life quality

    Change from baseline in life quality at 6 months

Study Arms (2)

Placebo/Ganoderma

PLACEBO COMPARATOR

In control group, oral placebos for 6 weeks. Then the patients in control groups are switched, Ganoderma Spores Powder Capsules 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.

Other: Control groupDietary Supplement: Ganoderma Spores Powder Capsules

Ganoderma

EXPERIMENTAL

In experimental group, Ganoderma Spores Powder Capsules for 12 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.

Dietary Supplement: Ganoderma Spores Powder Capsules

Interventions

Control groupOTHER

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.

Placebo/Ganoderma
Ganoderma Spores Powder CapsulesDIETARY_SUPPLEMENT

In experimental group, Ganoderma Spores Powder Capsules for 12 weeks.

GanodermaPlacebo/Ganoderma

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital

Changhua County, Taiwan

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Kuender D. Yang, PhD

    Chang Bing Show Chwan Memorial Hospital

    STUDY DIRECTOR

  • Ching-Yeh Hsiung

    Chang Bing Show Chwan Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ching-Yeh Hsiung

CONTACT

886-975617327hsiungcy@hotmail.com

Kuender D. Yang

CONTACT

886-975617006yangkd.yeh@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Professor

Study Record Dates

First Submitted

September 8, 2014

First Posted

September 12, 2014

Study Start

June 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

September 12, 2014

Record last verified: 2014-09

Locations

TW(1)